Pfizer–BioNTech COVID-19 vaccine explained

Type:vaccine
Target:SARS-CoV-2
Vaccine Type:mrna
Tradename:Comirnaty
Licence Eu:yes
Dailymedid:Pfizer-BioNTech COVID-19 vaccine
Pregnancy Au:B1
Pregnancy Au Comment:[1]
Routes Of Administration:Intramuscular
Atc Prefix:J07
Atc Suffix:BN01
Legal Au:S4
Legal Au Comment:[2] [3] [4] [5] [6] [7] [8] [9] [10] [11]
Legal Br:Approved
Legal Br Comment:[12] [13]
Legal Ca:Rx-only
Legal Ca Comment:/ Schedule D[14] [15] [16]
Legal Uk:Conditional marketing authorization granted
Legal Uk Comment:[17] [18] [19]
Legal Us:Rx-only
Legal Us Comment:with standing order; Approved for those aged 12+; Emergency Use Authorization for those aged 6 months–11 years[20] [21] [22] [23] [24] [25] [26] [27]
Legal Eu:Marketing authorization granted
Legal Status:

Rx-only

Section 21[28] [29]

Full list of Pfizer-BioNTech vaccine authorizations

Cas Number:2417899-77-3
Pubchemsubstance:434370509
Drugbank:DB15696
Unii:5085ZFP6SJ
Kegg:D11971
Chembl:4650429
Synonyms:BNT162b2, COVID-19 mRNA vaccine (nucleoside-modified), COVID-19 Vaccine (mRNA)[30]

The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty,[31] is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with the American company Pfizer to carry out clinical trials, logistics, and manufacturing.[32] It is authorized for use in humans to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) that encodes a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.[33] Initial guidance recommended a two-dose regimen, given 21 days apart;[34] [35] this interval was subsequently extended to up to 42 days in the United States,[36] and up to four months in Canada.[37] [38]

Clinical trials began in April 2020; by November 2020, the vaccine had entered phaseIII clinical trials, with over 40,000 people participating.[39] Interim analysis of study data showed a potential efficacy of 91.3% in preventing symptomatic infection within seven days of a second dose and no serious safety concerns.[40] [41] Most side effects are mild to moderate in severity and resolve within a few days.[42] Common side effects include mild to moderate pain at the injection site, fatigue, and headaches.[43] [44] Reports of serious side effects, such as allergic reactions, remain very rare with no long-term complications documented.[45]

The vaccine is the first COVID19 vaccine to be authorized by a stringent regulatory authority for emergency use[46] [47] and the first to be approved for regular use.[48] In December 2020, the United Kingdom was the first country to authorize its use on an emergency basis. It is authorized for use at some level in the majority of countries.[49] [50] [51] [52] On 23 August 2021, the Pfizer–BioNTech vaccine became the first COVID-19 vaccine to be approved in the US by the Food and Drug Administration (FDA).[53] The logistics of distributing and storing the vaccine present significant challenges due to the requirement for its storage at extremely low temperatures.[54]

In August 2022, a bivalent version of the vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) was authorized for use as a booster dose in individuals aged twelve and older in the US.[55] [56] [57] [58] The following month, the BA.1 version of the bivalent vaccine (Comirnaty Original/Omicron BA.1 or tozinameran/riltozinameran)[59] was authorized as a booster for use in the UK.[60] [61] The same month, the European Union authorized both the BA.1 and the BA.4/BA.5 (tozinameran/famtozinameran) booster versions of the bivalent vaccine.

Medical uses

The Pfizer–BioNTech COVID-19 vaccine is used to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus, by eliciting an immune response to the S antigen. The vaccine is used to reduce morbidity and mortality from COVID-19.

The vaccine is supplied in a multidose vial as "a white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection". It must be thawed to room temperature and diluted with normal saline before administration.[62]

The initial course consists of two doses. The World Health Organization (WHO) recommends an interval of three to four weeks between doses. Delaying the second dose by up to twelve weeks increases immunogenicity, even in older adults, against all variants of concern. Authors of the Pitch study think that the optimal interval against the Delta variant is around eight weeks, with longer intervals leaving receptors vulnerable between doses.[63]

A third, fourth, or fifth dose can be added in some countries.[64] [65]

Effectiveness

A test-negative[66] case-control study published in August 2021, found that two doses of the BNT162b2 (Pfizer) vaccine had 93.7% effectiveness against symptomatic disease caused by the alpha (B.1.1.7) variant and 88.0% effectiveness against symptomatic disease caused by the delta (B.1.617.2) variant.[67] Notably, effectiveness after one dose of the Pfizer vaccine was 48.7% against alpha and 30.7% against delta, similar to effectiveness provided by one dose of the ChAdOx1 nCoV-19 vaccine.[68]

On 27 August, the U.S. Centers for Disease Control and Prevention (CDC) published a study reporting that the effectiveness against infection decreased from to when the Delta variant became predominant in the US, which may be due to unmeasured and residual confounding related to a decline in vaccine effectiveness over time.[69]

Unless indicated otherwise, the following effectiveness ratings are indicative of clinical effectiveness two weeks after the second dose. A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.[70] Effectiveness is generally expected to slowly decrease over time.[71]

On 12 November, Public Health England reported a possible but extremely small reduction in effectiveness against symptomatic disease from the Delta sublineage AY.4.2 at longer intervals after the second dose.[72]

Preliminary data suggest that the effectiveness against the Omicron variant starts to decline in about 10 weeks, either after the initial two-dose regimen or after the booster dose. For other variants, the effectiveness of the initial doses starts to decline in about six months.[73] A case-control study in Qatar from 1 January to 5 September 2021 found that effectiveness against infection peaked at in the first month after the second dose, followed by a slow decline that accelerated after the fourth month, reaching 20% at months 5 to 7. A similar trajectory was observed against symptomatic disease and against specific variants. Effectiveness against severe disease, hospitalization and death was more robust, peaking at in the second month and remaining almost stable through the sixth month, declining thereafter.[74]

On 21 October, a phase 3 trial showed that a booster dose given approximately 11 months after the second dose restored the protective effect to the efficacy level against symptomatic disease from the Delta variant.[75] [76]

On 8 December, Pfizer and BioNTech reported that preliminary data indicated that a third dose of the vaccine would provide a similar level of neutralizing antibodies against the Omicron variant as seen after two doses against other variants.[77]

On 14 December, private health insurer Discovery Health, in collaboration with the South African Medical Research Council, reported that real-world data from more than 211,000 cases of COVID-19 in South Africa, of which 78,000 were of the Omicron variant, indicate that effectiveness against the variant after two doses is about 70% against hospital admission and 33% against symptomatic disease. Protection against hospital admission is maintained for all ages and groups with comorbidities.[78]

A study of the bivalent booster effectiveness against severe COVID-19 outcomes in Finland, September 2022–January 2023, has shown that it reduced the risk of severe COVID-19 outcomes among the elderly. By contrast, among the chronically ill 18–64-year-olds the risk was similar among those who received bivalent vaccine and those who did not. Among the elderly a bivalent booster provided highest protection during the first two months after vaccination, but thereafter signs of waning were observed. The effectiveness among individuals aged 65–79 years and those aged 80 years or more was similar.[79]

Specific populations

Based on the results of a preliminary study, the U.S. Centers for Disease Control and Prevention (CDC) recommends that pregnant women get vaccinated with the COVID19 vaccine.[80] [81]

A statement by the British Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) reported that the two agencies had reached a conclusion that the vaccine is safe and effective in children aged between 12 and 15 years.[82] [83]

On 19 May 2021, experts commissioned by the Norwegian Medicines Agency concluded that the Pfizer-BioNTech vaccine is the likely cause of ten deaths of frail elderly patients in Norwegian nursing homes. They said that people with very short life expectancies have little to gain from vaccination, having a real risk of adverse reactions in the last days of life and of dying earlier.[84]

A 2021 report by the New South Wales Government (NSW Health) in Australia found that the Pfizer-BioNTech vaccine is safe for those with various forms of immunodeficiency or immunosuppression, though it does note that the data on said groups is limited, due to their exclusion from many of the vaccine earlier trials held in 2020. It notes that the World Health Organization advises that the vaccine is among the three COVID-19 vaccines (alongside that of Moderna and AstraZeneca) it deems safe to give to immunocompromised individuals, and that expert consensus generally recommends their vaccination. The report states that the vaccines were able to generate an immune response in those individuals, though it does also note that this response is weaker than in those that are not immunocompromised. It recommends that specific patient groups, such as those with cancer, inflammatory bowel disease and various liver diseases be prioritised in the vaccination schedules over other patients that do not have said conditions.[85]

On 20 September 2021, Pfizer announced that a clinical trial conducted in more than 2,200 children aged 5–11 has generated a "robust" response and is safe.[86] [87]

Adverse effects

See also: Vaccine adverse event.

In Phase III trials for the vaccine, there were no safety concerns and few adverse events.

Most side effects of the Pfizer–BioNTech COVID19 vaccine are mild to moderate in severity, and are gone within a few days. They are similar to other adult vaccines and are normal signs that the body is building protection to the virus. During clinical trials, the common side effects affecting more than one in 10 people are (in order of frequency): pain and swelling at the injection site, tiredness, headache, muscle aches, chills, joint pain, fever or diarrhea. Fever is more common after the second dose.

The European Medicines Agency (EMA) regularly reviews the data on the vaccine's safety. The safety report published on 8 September 2021 by the EMA was based on over 392million doses administered in the European Union. According to the EMA "the benefits of Comirnaty in preventing COVID19 continue to outweigh any risks, and there are no recommended changes regarding the use of this vaccine." Rare side effects (that may affect up to one in 1,000 people) include temporary one sided facial drooping and allergic reactions, such as hives or swelling of the face.

Allergy

Documented hypersensitivity to polyethylene glycol (PEG) (a very rare allergy) is listed as a contraindication to the COVID-19 Pfizer vaccine.[88] Severe allergic reaction has been observed in approximately eleven cases per million doses of vaccine administered.[89] [90] According to a report by the US Centers for Disease Control and Prevention, 71% of those allergic reactions happened within 15 minutes of vaccination and mostly (81%) among people with a documented history of allergies or allergic reactions. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) advised on 9December 2020 that people who have a history of "significant" allergic reaction should not receive the Pfizer–BioNTech COVID19 vaccine.[91] [92] [93] On 12 December, the Canadian regulator followed suit, noting that: "Both individuals in the U.K. had a history of severe allergic reactions and carried adrenaline auto injectors. They both were treated and have recovered."[94]

Myocarditis

In June 2021, the Israel's Ministry of Health announced a probable relationship between the second dose and myocarditis in a small group of 16–30-year-old men.[95] Between December 2020 and May 2021, there were 55 cases of myocarditis per 1million people vaccinated, 95% of which were classified as mild and most spent no more than four days in the hospital. Since April 2021, increasing number of cases of myocarditis and pericarditis have been reported in the United States in about 13 per 1million young people, mostly male and over the age of 16, after vaccination with the Pfizer–BioNTech or the Moderna vaccine.[96] [97] Most affected individuals recover quickly with adequate treatment and rest.[98] Since February 2022, the German Standing Committee on Vaccination recommends aspiration for COVID-19 vaccination as precautionary measure.[99]

Pharmacology

See also: RNA vaccine.

The BioNTech technology for the BNT162b2 vaccine is based on use of nucleoside-modified mRNA (modRNA) which encodes a mutated form of the full-length spike protein found on the surface of the SARS-CoV-2 virus,[100] triggering an immune response against infection by the virus protein.[101]

Sequence

The modRNA sequence of the vaccine is 4,284 nucleotides long.[102] It consists of a five-prime cap; a five prime untranslated region derived from the sequence of human alpha globin; a signal peptide (bases 55–102) and two proline substitutions (K986P and V987P, designated "2P") that cause the spike to adopt a prefusion-stabilized conformation reducing the membrane fusion ability, increasing expression and stimulating neutralizing antibodies;[103] a codon-optimized gene of the full-length spike protein of SARS-CoV-2 (bases 103–3879); followed by a three prime untranslated region (bases 3880–4174) combined from AES and mtRNR1 selected for increased protein expression and mRNA stability[104] and a poly(A) tail comprising 30 adenosine residues, a 10-nucleotide linker sequence, and 70 other adenosine residues (bases 4175–4284).[102] The sequence contains no uridine residues; they are replaced by 1-methyl-3'-pseudouridylyl.[102] The 2P proline substitutions in the spike proteins were originally developed for a Middle East respiratory syndrome (MERS) vaccine by researchers at the National Institute of Allergy and Infectious Diseases' Vaccine Research Center, Scripps Research, and Jason McLellan's team (at the University of Texas at Austin, previously at Dartmouth College).

Chemistry

In addition to the mRNA molecule, the vaccine contains the following inactive ingredients (excipients):[105] [94] [106]

The first four of these are lipids. The lipids and modRNA together form nanoparticles that act not only as carriers to get the modRNA into the human cells, but also as adjuvants.[107] ALC-0159 is a polyethylene glycol conjugate, i.e., a PEGylated lipid.[108]

Manufacturing

Pfizer and BioNTech are manufacturing the vaccine in their own facilities in the United States and in Europe. The license to distribute and manufacture the vaccine in China was purchased by Fosun, alongside its investment in BioNTech.

Manufacturing the vaccine requires a three-stage process. The first stage involves the molecular cloning of DNA plasmids that code for the spike protein by infusing them into Escherichia coli bacteria. For all markets, this stage is conducted in the United States,[109] at a small Pfizer pilot plant in Chesterfield, Missouri[110] [111] (near St. Louis). After four days of growth, the bacteria are killed and broken open, and the contents of their cells are purified over a week and a half to recover the desired DNA product. The DNA is bottled and frozen for shipment. Safely and quickly transporting the DNA at this stage is so important that Pfizer has used its company jet and helicopter to assist.[112]

The second stage is being conducted at a Pfizer plant in Andover, Massachusetts,[113] in the United States, and at BioNTech's plants in Germany. The DNA is used as a template to build the desired mRNA strands, which takes about four days. Once the mRNA has been created and purified, it is frozen in plastic bags about the size of a large shopping bag, of which each can hold up to 10million doses. The bags are placed on trucks which take them to the next plant.The third stage is being conducted at Pfizer plants in Portage, Michigan[114] (near Kalamazoo) in the United States, and Puurs in Belgium. This stage involves combining the mRNA with lipid nanoparticles, then filling vials, boxing vials, and freezing them. Croda International subsidiary Avanti Polar Lipids is providing the requisite lipids.[115] As of November 2020, the major bottleneck in the manufacturing process is combining mRNA with lipid nanoparticles. At this stage, it takes only four days to go from mRNA and lipids to finished vials, but each lot must then spend several weeks in deep-freeze storage while undergoing verification against 40 quality-control measures.

Before May 2021,[116] the Pfizer plant in Puurs was responsible for all vials for destinations outside the United States. Therefore, all doses administered in the Americas outside of the United States before that point in time required at least two transatlantic flights (one to take DNA to Europe and one to bring back finished vaccine vials).

In February 2021, BioNTech announced it would increase production by more than 50% to manufacture 2billion doses in 2021,[117] raised again at the end of March to 2.5billion doses in 2021.[118]

In February 2021, Pfizer revealed that the entire sequence initially took about 110 days on average from start to finish, and that the company is making progress on reducing the time to 60 days.[119] More than half the days in the production process are dedicated to rigorous testing and quality assurance at each of the three stages. Pfizer also revealed that the process requires 280 components and relies upon 25 suppliers located in 19 countries.

Vaccine manufacturers normally take several years to optimize the process of making a particular vaccine for speed and cost-effectiveness before attempting large-scale production. Due to the urgency presented by the COVID-19 pandemic, Pfizer and BioNTech began production immediately with the process by which the vaccine had been originally formulated in the laboratory, then started to identify ways to safely speed up and scale up that process.BioNTech announced in September 2020, that it had signed an agreement to acquire a manufacturing facility in Marburg, Germany, from Novartis to expand their vaccine production capacity.[120] Once fully operational, the facility would produce up to 750million doses per year, or more than 60million doses per month. The site will be the third BioNTech facility in Europe that produces the vaccine, while Pfizer operates at least four production sites in the United States and Europe.

The Marburg facility had previously specialized in cancer immunotherapy for Novartis.[121] By the end of March 2021, BioNTech had finished retrofitting the facility for mRNA vaccine production and retraining its 300 staff, and obtained approval to begin manufacturing. Besides making mRNA, the Marburg facility also performs the step of combining mRNA with lipids to form lipid nanoparticles, then ships the vaccine in bulk to other facilities for fill and finish (i.e., filling and boxing vials).

On 23 April 2021, the EMA authorized an increase in batch size and associated process scale up at Pfizer's plant in Puurs. This increase is expected to have a significant impact on the supply of the vaccine in the European Union.[122] [123]

At the end of April 2021, it was reported that Pfizer had started to export vaccine doses to Mexico and Canada from the Kalamazoo plant, which is much closer geographically to both countries than the Puurs plant.

Logistics

The vaccine is delivered in vials that, once diluted, contain 2.25 mL of vaccine, comprising 0.45 mL frozen and 1.8 mL diluent. According to the vial labels, each vial contains five 0.3 mL doses, however excess vaccine may be used for one, or possibly two, additional doses.[124] The use of low dead space syringes to obtain the additional doses is preferable, and partial doses within a vial should be discarded.[125] The Italian Medicines Agency officially authorized the use of excess doses remaining within single vials.[126] The Danish Health Authority allows mixing partial doses from two vials.[127] As of 8January 2021, each vial contains six doses.[128] [129] In the United States, vials will be counted as five doses when accompanied by regular syringes and as six doses when accompanied by low dead space syringes.[130] The vaccine can be stored at 2to for thirty days before use[131] [132] and at 25C or 30C [133] for up to two hours before use. During distribution the vaccine is stored in special containers that maintain temperatures between -80and.[134]

Low-income countries have limited cold chain capacity for ultracold transport and storage of a vaccine.[135] The necessary storage temperatures for the vaccine[136] [137] are much lower than for the similar Moderna vaccine. The head of Indonesia's Bio Farma Honesti Basyir said purchasing the vaccine is out of the question for the world's fourth-most populous country, given that it did not have the necessary cold chain capability. Similarly, India's existing cold chain network can handle only temperatures between 2and, far above the requirements of the vaccine.[138] [139]

History

Before COVID19 vaccines, creating a vaccine for an infectious disease from scratch had never before been produced in less than the five years it had taken in 1967 when Maurice Hilleman had set the modern record with a vaccine for mumps, followed by the vaccine for Ebola also taking five years.[140] As of 2019 no vaccine existed for preventing a coronavirus infection in humans.[141] The SARS-CoV-2 virus, which causes COVID19, was detected in December 2019,[142]

The development of the Pfizer- BioNTech COVID19 vaccine began when BioNTech founder and CEO Uğur Şahin while at his home in Mainz on Friday 24 January 2020, was checking out his regular websites when he noted a report in the science section of Der Spiegel website about novel respiratory illness that had affected approximately 50 people in Wuhan.He then came across a submission from Hong Kong-based researchers on the website of the medical journal The Lancet in which they discussed a cluster of pneumonia associated with coronavirus and an indication of person-to-person transmission that had affected a family that had recently returned from Wuhan.[143] The authors of the submission were of the opinion that they were observing the early stages of an epidemic,

While no infectious disease expert Şahin did some quick calculations based on Wuhan's population and transport links and came to the conclusion that if this virus was possible of person-to-person transmission then it could cause a morality rate somewhere between 0.3 and 10 out of every 100 inflected people to give a best case scenario of two million deaths worldwide. This would expose him, his family, colleagues to danger. At the time there were 1,000 internationally confirmed cases of the virus. Later that day he sent an email to Helmut Jeggle, chairman of BioNTech to alert him of his conclusions. The next day he discussed it with his wife Özlem Türeci and his belief that once it reached Germany local schools would be closed by April. During a telephone call with Jeggle that same day he discussed potential impact of such a virus.Şahin and Türeci had previously identified that the mRNA vaccine technology that the company had been developing offered the possibly of being used to create a suitable vaccine.[144] While the company had a small team which had started developing vaccines for infectious disease and had collaborating with Pfizer on a flu vaccine BioNTech was after 11 years of financial losses totalling more than €400 million was concentrating its efforts on developing mRNA as a means of fighting cancer. However, realizing the risk and believing that the company's proprietary mRNA technology at now at the stage where they had the tools to create a vaccine Şahin after discussing it with his wife, spent that weekend outlining the technical construction of eight possible vaccine candidates based on the company's mRNA platforms. He was assisted in his work by the SARS-CoV-2 genetic sequences having been previously published on 11 January 2020 by Edward C. Holmes in association with Zhang Yongzhen, a professor at the Chinese Center for Disease Control and Prevention on open-source website Virological.org. This triggered an urgent international response to prepare for an outbreak and hasten development of preventive vaccines.[145] [146]

On Monday 27 January Şahin had a series of meetings with the company's few infectious experts and the leaders of most of the departments to discuss his concerns about the virus and to announce his decision to establish a new project called 'Lightspeed' that would use all of the company's available resources to develop a vaccine.[39] He also decided that rather than follow the traditional method of developing a single prototype and then discard it if it didn't work and then start again they would develop and test multiple vaccines in parallel. They would then discard the least promising.

BioNTech approaches Pfizer about collaborating

At the board meeting the next day Şahin received permission to spend over the next weeks a limited amount of money that the company and its 1,300 personnel investigating the development of a vaccine, after which they would reevaluate whether to continue. The board then considered whether to build up their capability to fully manufacture, document, sell and distribute any potential vaccine they decided that this would take too long and it would be better to partner with a pharma giant. Since the company had been collaborating with Pfizer since 2018 on developing a mRNA vaccine for influenza. Şahin called Pfizer's chief scientific officer, Phil Dormitzer later that Tuesday to tell them what they were doing and ask if they were interested in collaborating with BioNTech. Dormitzer was lukewarm as he felt that this new virus would be able to controlled and confined to China by public health measures and a few hours later confirmed on behalf of Pfizer that they were not interested.

Consulting the Paul Ehrlich Institute

Prior to contacting Pfizer, Şahin had contacted Klaus Cichutek at the Paul Ehrlich Institute (PEI) in Langen, which was Germany's drug regulator to ask for his assistance in arranging a meeting with a panel of experts to discuss a vaccine development strategy and to determine what needed to be done to receive authorisations to undertake a clinical trial. As it was taking the Wuhan developments very seriously PEI was more than willing to help and had already initiated a vaccine development programme and was providing emergency advice to other drug makers and waiving its administration fees. it was more than willing to assist BioNTech and came back two days later to say that provided a detailed briefing dossier could be delivered in time would meet with them the next week.

Corinna Rosenbaum who was the lead project manager on the BioNTech flu project was asked to prepare what eventually was a 50-page dossier detailing how the company had the expertise and technology to create a safe vaccine. Crucial to the delivery of an mRNA vaccine to its cellular destination via an injection into a human muscle was the availability of a suitable wrapper made of lipid nano particles to protect it from the body's enzymes. The company had no experience in them they approached Acuitas Therapeutics whose proprietary wrapper technology was already being used in human trials and for which all of the necessary safety data was available. This would assist in gaining PEI approval. This small Canadian company of 25 staff was led by Tom Madden. An advantage of using Acuitas Therapeutics was that their ALC-0315 lipid formulation was already available at Polymun which was one of the only companies which had the expertise to immediately combine lipids with mRNA. Polymun was located near Vienna in Austria, an eight-hour drive from BioNTech's headquarters, which would be make it easier for material had to transported between the two companies. On Monday 3 February Acuitas Therapeutics agreed to assist. With Acuitas Therapeutics on board the briefing dossier was able to be completed and was sent to PEI late on Tuesday, 4 February, six days after work had commenced on compiling it.

On 6 February Şahin, Türeci and Rosenbaum together with Tom Madden and Chris Barbosa from Acuitas Therapeutics met with PEI who were happy with what BioNTech proposed, with the only point of contention being PEI rejecting BioNTech proposal to either skip altogether or run toxicology studies in parallel with clinical trials before human trials could begin.This was important as while the individual components had been shown by trials to not cause any significant issues in humans there was no safety data on the combination of mRNA and lipids. Toxicology studies on mice or rats normally took five months. At this point in time PEI main concerns were about whether there were any benefits in speeding up the normal process.For the vaccine to work it needed to deliver a stable accurate replica of the virus's spike protein so that the body's immune system could recognize and react to COVID19 if they became infected. In developing a stable replica, the team was assisted by advice from Barney S. Graham who had been studying the MERS virus, which was approximately 54% identical to the uploaded COVID-19 genetic code.

There were two options, one was to reproduce a full likeness of entire spike protein which would contain approximately 1,200 amino acids (protein building blocks) increase the risk of antibody-dependent enhancement (ADE) complications. The other was to reproduce only the tip of the spike protein which was known as binding domain receptor (RBD). RDB was simpler as it would contain approximately 200 amino acids and risk of ADE would be reduced. Şahin decided that BioNTech would explore both methods.

Development of parallel candidates

BioNTech decided to simultaneously develop in parallel in their laboratory in Mainz 20 possible COVID19 vaccine permutations in different doses based on all four versions of synthetic mRNA platforms that they had developed, modified mRNA (modRNA), uridine RNA (uRNA), self-amplifying mRNA (saRNA) and trans-amplifying mRNA (taRNA).[147]

Using the genetic sequences that were available on Virological.org a team at BioNTech led by Stephanie Hein used gene synthesis to create DNA hardcopies, which were to be used to create the templates to make the mRNA. These hardcopies each contained up to 4,000 nucleotides, which were assembled from 50 to 80 smaller building blocks.Once these DNA templates was produced another team created the actual mRNA vaccine candidates, the first batch of which was produced on 2 March. This was then poured into a 50 ml bag, frozen to minus 70 degrees Celsius and dispatched by a waiting car to Polymun to be combined with the lipids, a process that was to followed by the rest of the 20 candidates.

Once the first vials containing the lipid wrapped mRNA candidates were revied back in Mainz on 9 March a team led by Annette Vogel began testing them to determine which using at various dosage amounts induced the best immune responses, first in glass dishes and then at a separate location, in mice. Each of the candidates was tested in three dosages, low, medium and high with each given to eight mice, with their blood then sampled and analyzed over the next six weeks. The blood was analyzed by a team led by Lena Kranz and Mathias Vormehr to check to see if the mice's T-cells reacted and carried out the required immune response. These tests showed that all 20 candidates produced an immune response in the mice. In parallel Annette Vogel was also using enzyme-linked immunosorbent assays (ELISA) to determine using a virus neutralisation test (VNT) if the candidates were inducing sufficient neutralising antibodies. Because of the risk that COVID19 posed this testing had to be done in a biosafety level three (BSL-3) laboratory, which BioNTech didn't have. Fortunately, they were able to get around this by creating a vesicular stomatitis virus (VSV) pseudovirus to replace the harmful elements with the isolated spike proteins from SARS-CoV-2. A working prototype pseudovirus test was ready by 10 March. This meant the laboratory security requirements could be downgraded to BSL-1, which the company had onsite.

To obtain a return on its investment in 'Project Lightspeed Helmut' Jeggle was of the opinion that the company had to take advantage of the massive demand by being among the first three to the market with a vaccine. To do this BioNTech needed the evolvement of either GSK, Johnson & Johnston, Merck, Pfizer or Sanofi, who alone had the financial resources, manufacturing ability and territorial coverage to undertake the massive Phase 3 trials needed to prove to the regulators that the vaccine was safe.

BioNTech reapproaches Pfizer about collaborating

Despite the earlier rebuff from Pfizer the company still preferred to partner with them. In the meantime they were able to reach what was in effect a licensing agreement on 16 March with Shanghai-based Fosun.On 3 March Şahin was able to contact Kathrin Jansen, head of vaccine research and development at Pfizer that BioNTech who by now was of the opinion that mRNA was the best means of creating a COVID19 vaccine. She took the idea of a collaboration to Pfizer CEO Albert Bourla. While the two companies had been working together since 2018 on developing a mRNA vaccine for influenza, it was only now that their two chief executives became personally acquainted.[148] After a few phone calls, Bourla agreed that Pfizer would work with BioNTech on the development of BioNTech's COVID-19 vaccine a with work commencing immediately, with no formal written legal agreement in place to govern the new collaboration.[148] BioNTech transferred its know-how to Pfizer the next day.[148] Bouria agreed on the 50:50 partnership that Şahin proposed with each company equally sharing costs and any potential profits. Because of BioNTech's limited financial ability Pfizer agreed to fund Biontech's cost which was expected to be $190 million which would be paid back. As far as Bourla was concerned COVID19 was so important that he had told his staff that they had an “open cheque”.

On 13 March it was formally announced that BioNTech was collaborating with Pfizer with a letter of intent being signed on 17 March.[149] However it wasn't until January 2021the formal commercial agreement between Pfizer and BioNTech for the COVID-19 vaccine was signed.[148]

The release of news of the partnership bought BioNTech publicity that resulted the company receiving letters and telephone calls containing racists views and often death threats. Security was tightened and board members were offered personal protection.

Funding

According to Pfizer, research and development for the vaccine cost close to billion.[150]

BioNTech received a investment from Fosun on 16 March 2020, in exchange for 1.58million shares in BioNTech and the future development and marketing rights of BNT162b2 in China and surrounding territories.[151] [152]

In April 2020, BioNTech signed a partnership with Pfizer and received $185million, including an equity investment of approximately $113million.[153] [154]

In June 2020, BioNTech received in financing from the European Commission and European Investment Bank.[155] The Bank's deal with BioNTech started early in the pandemic, when the Bank's staff reviewed its portfolio and came up with BioNTech as one of the companies capable of developing a COVID19 vaccine. The European Investment Bank had already signed a first transaction with BioNTech in 2019.[156]

In September 2020, the German government granted BioNTech for its COVID19 vaccine development program.[157]

Pfizer CEO Albert Bourla said he decided against taking funding from the US government's Operation Warp Speed for the development of the vaccine "because I wanted to liberate our scientists [from] any bureaucracy that comes with having to give reports and agree how we are going to spend the money in parallel or together, etc." Pfizer did enter into an agreement with the US for the eventual distribution of the vaccine, as with other countries.[158]

Clinical trials

PhaseI–II Trials were started in Germany on 23 April 2020, and in the U.S. on 4May 2020, with four vaccine candidates entering clinical testing.[34] The vaccine candidate BNT162b2 was chosen as the most promising among three others with similar technology developed by BioNTech. Before choosing BNT162b2, BioNTech and Pfizer had conducted phaseI trials on BNT162b1 in Germany and the United States, while Fosun performed a PhaseI trial in China. In these PhaseI studies, BNT162b2 was shown to have a better safety profile than the other three BioNTech candidates.[159] [160] [161]

The Pivotal PhaseII–III Trial with the lead vaccine candidate "BNT162b2" began in July. Preliminary results from PhaseI–II clinical trials on BNT162b2, published in October 2020, indicated potential for its safety and efficacy. During the same month, the European Medicines Agency (EMA) began a periodic review of BNT162b2.[162]

The study of BNT162b2 is a continuous-phase trial in phaseIII as of November 2020. It is a "randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals". The study expanded during mid-2020 to assess efficacy and safety of BNT162b2 in greater numbers of participants, reaching tens of thousands of people receiving test vaccinations in multiple countries in collaboration with Pfizer and Fosun.

The phase III trial assesses the safety, efficacy, tolerability, and immunogenicity of BNT162b2 at a mid-dose level (two injections separated by 21 days) in three age groups: 12–15 years, 16–55 years or above 55 years. The PhaseIII results indicating a 95% efficacy of the developed vaccine were published on 18 November 2020. For approval in the EU, an overall vaccine efficacy of 95% was confirmed by the EMA.[163] The EMA clarified that the second dose should be administered three weeks after the first dose.[164]

At 14 days after dose 1, the cumulative incidence begins to diverge between the vaccinated group and the placebo group. The highest concentration of neutralizing antibodies is reached 7 days after dose 2 in younger adults and 14 days after dose 2 in older adults.

Vaccine efficacy against confirmed symptomatic COVID19! Endpoint subgroup! Efficacy (95% confidence interval)
All ages
Age 12–17Not estimable
Age 18–64
Age 65–74
Age ≥75
All ages, after dose 1, before dose 2
All ages, ≥10 days after dose 1, before dose 2
All ages, <7 days after dose 2
All ages, ≥7 days after dose 2
All ages, USA
All ages, Argentina
All ages, Brazil

The ongoing phase III trial, which is scheduled to run from 2020 to 2022, is designed to assess the ability of BNT162b2 to prevent severe infection, as well as the duration of immune effect.[165] [166]

High antibody activity persists for at least three months after the second dose, with an estimated antibody half-life of 55 days. From these data, one study suggested that antibodies might remain detectable for around 554 days.[167]

Specific populations

Pfizer and BioNTech started a PhaseII–III randomized control trial in healthy pregnant women 18 years of age and older (NCT04754594). The study will evaluate 30mcg of BNT162b2 or placebo administered via intramuscular injection in two doses, 21 days apart. The PhaseII portion of the study will include approximately 350 pregnant women randomized 1:1 to receive BNT162b2 or placebo at 27 to 34 weeks' gestation. The PhaseIII portion of this study will assess the safety, tolerability, and immunogenicity of BNT162b2 or placebo among pregnant women enrolled at 24 to 34 weeks' gestation. Pfizer and BioNTech announced on 18 February 2021 that the first participants received their first dose in this trial.

A study published in March 2021, in the American Journal of Obstetrics and Gynecology came to the conclusion that messenger RNA vaccines against the novel coronavirus, such as the Pfizer-BioNTech and Moderna vaccines were safe and effective at providing immunity against infection to pregnant and breastfeeding mothers. Furthermore, they found that naturally occurring antibodies created by the mother's immune system were passed on to their children via the placenta and/or breastmilk, thus resulting in passive immunity among the child, effectively giving the child protection against the disease. The study also found that vaccine-induced immunity among the study's participants was stronger in a statistically significant way over immunity gained through recovery from a natural COVID19 infection. In addition, the study reported that the occurrence and intensity of potential side effects in those undergoing pregnancy or lactating was very similar to those expected from non-pregnant populations, remaining generally very minor and well tolerated, mostly including injection site soreness, minor headaches, muscles aches or fatigue for a short period of time.[168]

In January 2021, Pfizer said it had finished enrolling 2,259 children aged between 12 and 15 years to study the vaccine's safety and efficacy.[169] On 31 March 2021, Pfizer and BioNTech announced from initial PhaseIII trial data that the vaccine is 100% effective for those aged 12 to 15 years of age, with trials for those younger still in progress.[170]

A research letter published in JAMA reported that the vaccines appeared to be safe for immunosuppressed organ transplant recipients, but that the resulting antibody response was considerably poorer than in the non-immunocompromised population after only one dose. The paper admitted the limitation of only reviewing the data following the first dose of a two-dose cycle vaccine.[171]

On 2 November 2021, The BMJ published a piece by journalist Paul D. Thacker alleging there has been "poor practice" at Ventavia, one of the companies involved in the phase III evaluation trials of the Pfizer vaccine.[172] The report was enthusiastically embraced by anti-vaccination activists. David Gorski commented in Science-Based Medicine that Thacker's article presented facts without necessary context to misleading effect, playing up the seriousness of the noted problems.[173]

Authorizations

Although jointly developed with Pfizer,[174] Comirnaty is based on BioNTech's proprietary mRNA technology, and BioNTech holds the Marketing Authorization in the United States, the European Union, the UK, and Canada; expedited licenses such as the US emergency use authorization (EUA) are held jointly with Pfizer in many countries.

Expedited

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) gave the vaccine "rapid temporary regulatory approval to address significant public health issues such as a pandemic" on 2December 2020, which it is permitted to do under the Medicines Act 1968. It is the first COVID19 vaccine to be approved for national use after undergoing large scale trials,[175] and the first mRNA vaccine to be authorized for use in humans.[176] The United Kingdom thus became the first Western country to approve a COVID19 vaccine for national use,[177] although the decision to fast-track the vaccine was criticized by some experts.[178]

After the United Kingdom, the following countries and regions expedited processes to approve the Pfizer–BioNTech COVID19 vaccine for use: Argentina,[179] Australia,[180] Bahrain,[181] Canada,[182] [183] Chile,[184] Costa Rica,[185] Ecuador, Hong Kong,[186] Iraq,[187] Israel,[188] Jordan,[189] Kuwait,[190] Malaysia,[191] Mexico,[192] [193] Oman,[194] Panama,[195] the Philippines,[196] Qatar,[197] Saudi Arabia,[198] [199] [200] Singapore,[201] [202] [203] South Korea,[204] [205] the United Arab Emirates,[206] the United States,[207] and Vietnam.[208]

The World Health Organization (WHO) authorized it for emergency use.[209] [210] [211] [212]

In the United States, an emergency use authorization (EUA) is "a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic", according to the Food and Drug Administration (FDA).[213] Pfizer applied for an EUA on 20 November 2020,[214] and the FDA approved the application three weeks later on 11 December 2020. The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) approved recommendations for vaccination of those aged sixteen years or older.[215] [216] Following the EUA issuance, BioNTech and Pfizer continued the PhaseIII clinical trial to finalize safety and efficacy data, leading to application for licensure (approval) of the vaccine in the United States.[217] [218] On 10 May 2021, the US FDA also authorized the vaccine for people aged 12 to 15 under an expanded EUA.[219] [220] The FDA recommendation was endorsed by the ACIP and adopted by the CDC on 12 May 2021.[221] [222] In October 2021, the EUA was expanded to include children aged 5 through 11 years of age.[223] In June 2022, the EUA was expanded to include children aged six months through four years of age.

On 16 February 2021, the South African Health Products Regulatory Authority (SAHPRA) in South Africa issued Section 21, Emergency Use Approval for the vaccine.[224] [225]

On 5 May 2021, Health Canada authorized the vaccine for people aged 12 to 15.[226] [227] On 18 May 2021, Singapore's Health Sciences Authority authorized the vaccine for people aged 12 to 15.[228] The European Medicines Agency (EMA) followed suit on 28 May 2021.[229]

On 4 June 2021, the UK Medicines and Healthcare products Regulatory Agency (MHRA) came to a similar decision and approved the use of the vaccine for people twelve years of age and older.

Standard

On 19 December 2020, the Swiss Agency for Therapeutic Products (Swissmedic) granted temporary authorization for the Pfizer–BioNTech COVID19 vaccine for regular use, two months after receiving the application, saying the vaccine fully complied with the requirements of safety, efficacy and quality.[230] [231] [232] [233] [234] This is the first authorization under a standard procedure.[235]

On 21 December 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting conditional marketing authorization for the Pfizer–BioNTech COVID19 vaccine under the brand name Comirnaty.[236] [237] The recommendation was accepted by the European Commission the same day.[238]

On 23 February 2021, the Brazilian Health Regulatory Agency approved the Pfizer–BioNTech COVID19 vaccine under its standard marketing authorization procedure.[239] [240] [241] [242] In June 2021, the approval was extended to those aged twelve or over.[243] [244] Pfizer's negotiation process with Brazil (and other Latin American countries) was described as "bullying". The contract prohibits the state of Brazil from publicly discussing the existence or the terms of their agreement with Pfizer–BioNTech without the former's written consent. Brazil was also restricted from donating or receiving donations of vaccines.[245] [246]

In July 2021, the U.S. Food and Drug Administration (FDA) granted priority review designation for the biologics license application (BLA) for the Pfizer–BioNTech COVID-19 vaccine with a goal date for the decision in January 2022.[247] [248] On 23 August 2021, the FDA approved the vaccine for use for those aged sixteen years and older.[249] [250]

The Pfizer-BioNTech Comirnaty COVID-19 vaccine was authorized in Canada in September 2021, for people aged twelve and older.[251] [252] [253] [254]

In July 2022, the FDA approved the vaccine for use for those aged twelve years and older.[255]

In September 2022, the CHMP of the EMA recommended converting the conditional marketing authorizations of the vaccine into standard marketing authorizations.[256] The recommendation covers all existing and upcoming adapted Comirnaty vaccines, including the adapted Comirnaty Original/Omicron BA.1 (tozinameran/riltozinameran) and Comirnaty Original/Omicron BA.4/5 (tozinameran/famtozinameran).

Administering of the first non-clinical doses

The first dose administered outside of a clinical trial was given to 90-year-old Margaret Keenan in the outpatient ward at Coventry University Hospital on 8 December 2020.[149] The vial and syringe used for her injection was subsequently sent for display to the Science Museum in London. The first dose administered outside of a clinical trial in the United States was given to Sandra Lindsay on 14 December 2020.[149]

Further development

Homologous prime-boost vaccination

In July 2021, Israel's Prime Minister announced that the country was rolling out a third dose of the Pfizer-BioNTech vaccine to people over the age of 60, based on data that suggested significant waning immunity from infection over time for those with two doses.[257] The country expanded the availability to all Israelis over the age of 12, after five months since their second shot. On 29 August 2021, Israel's coronavirus czar announced that Israelis who had not received a booster shot within six months of their second dose would lose access to the country's green pass vaccine passport.[258] Studies performed in Israel found that a third dose reduced the incidence of serious illness.[259]

In August 2021, the United States Department of Health and Human Services (HHS) announced a plan to offer a booster dose eight months after the second dose, citing evidence of reduced protection against mild and moderate disease and the possibility of reduced protection against severe disease, hospitalization, and death.[260] The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) authorized the use of an additional mRNA vaccine dose for immunocompromised individuals at that time.[261] [262] Scientists and the WHO noted in August 2021, the lack of evidence on the need for a booster dose for healthy people and that the vaccine remains effective against severe disease months after administration.[263] In a statement, the WHO and Strategic Advisory Group of Experts (SAGE) said that, while protection against infection may be diminished, protection against severe disease will likely be retained due to cell-mediated immunity.[264] Research into optimal timing for boosters is ongoing, and a booster too early may lead to less robust protection.[265]

In September 2021, the FDA and CDC authorizations were extended to provide a third shot for other specific groups.[266] [267] [268]

In October 2021, the European Medicines Agency (EMA) stated that a booster shot of the vaccine could be given to healthy people, aged 18 years and older, at least six months after their second dose. It also stated that people with "severely weakened" immune systems can receive an extra dose of either the Pfizer-BioNTech vaccine or the Moderna vaccine starting at least 28 days after their second dose.[269] The final approval to provide booster shots in the European Union will be decided by each national government.[270]

In October 2021, the FDA and the CDC authorized the use of either homologous or heterologous vaccine booster doses.[271] [272] [273]

In October 2021, the Australian Therapeutic Goods Administration (TGA) provisionally approved a booster dose of Comirnaty for people 18 years of age and older.[274] [275]

In January 2022, the FDA expanded the emergency use authorization to provide for the use of a vaccine booster dose to those aged 12 through 15 years of age, and it shortened the waiting period after primary vaccination to five months from six months.[276] [277] [278] [279]

In May 2022, the FDA expanded the emergency use authorization to provide for the use of a vaccine booster dose to those aged 5 through 11 years of age.[280]

In August 2022, the FDA revoked the emergency use authorization for the monovalent vaccine booster for people aged twelve years of age and older and replaced it with an emergency use authorization for the bivalent vaccine booster dose for the same age group.

Heterologous prime-boost vaccination

In October 2021, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) authorized the use of either homologous or heterologous vaccine booster doses. The authorization was expanded to include all adults in November 2021.

Bivalent booster vaccination

In August 2022, the "Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)" (in short: "COVID-19 Vaccine, Bivalent") received an emergency use authorization from the US Food and Drug Administration (FDA) for use as a booster dose in individuals aged twelve years of age and older. One dose contains 15mcg of "a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original)" and 15mcg "of modRNA encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5)".[281]

The bivalent vaccine authorized in the United States is different from the one that was authorized for use in the United Kingdom as the latter contains as second modRNA component 15mcg of modRNA enocoding the S gylcoprotein of the earlier BA.1 variant.

In September 2022, the European Union authorized both the BA.1 and the BA.4/BA.5 booster versions of the bivalent vaccine for people aged twelve years of age and older.[282]

While the Omicron BA.1 vaccine has been tested in a clinical study, the Omicron BA.4/BA.5 vaccine was only tested in pre-clinical studies. According to the published presentation,[283] the neutralization responses of Omicron BA.4/BA.5 monovalent, Omicron BA.1 mononvalent, Omicron BA.4/BA.5 bivalent and the original BNT162b2 vaccine have been explored in a study with BALB/c-mice.[284] [285]

In October 2022, the FDA amended the authorization for the bivalent booster to cover people aged five years of age and older.[286]

In December 2022, the FDA amended the authorization for the bivalent booster to be used as the third dose in people aged six months through four years of age.[287]

XBB.1.5 monovalent vaccine

In September 2023, the FDA approved an updated monovalent (single) component Omicron variant XBB.1.5 version of the vaccine (Comirnaty 20232024 formula) as a single dose for individuals aged twelve years of age and older; and authorized the Pfizer-BioNTech COVID-19 Vaccine 20232024 formula under emergency use for individuals aged 6 months through 11 years of age.[288] The approvals and emergency authorizations for the bivalent versions of the vaccine were revoked.[289] Health Canada approved the Pfizer-BioNTech Comirnaty Omicron XBB.1.5 subvariant, monovalent COVID19 vaccine in September 2023. The UK Medicines and Healthcare products Regulatory Agency approved the used of the Comirnaty Omicron XBB.1.5 vaccine in September 2023.[290] [291]

Society and culture

About 649million doses of the Pfizer–BioNTech COVID-19 vaccine, including about 55million doses in children and adolescents (below 18 years of age) were administered in the EU/EEA from authorization to 26 June 2022.[292]

Brand names

BNT162b2 was the code name during development and testing, tozinameran is the international nonproprietary name (INN),[293] and Comirnaty is the brand name. According to BioNTech, the name Comirnaty "represents a combination of the terms COVID19, mRNA, community, and immunity".[294] [295]

Famtozinameran is the INN for the BA.5 variant in the bivalent version of the vaccine.[296] [297] [298] [299] [300]

Raxtozinameran is the INN for the XBB 1.5 variant version of the vaccine.[301] [302] [303]

Economics

Pfizer reported revenue of million from the Pfizer–BioNTech COVID-19 vaccine in 2020,[304] and $36 billion in 2021.[305] [306]

In July 2020, the vaccine development program Operation Warp Speed placed an advance order of with Pfizer to manufacture 100million doses of a COVID19 vaccine for use in the United States if the vaccine was shown to be safe and effective.[307] [308] [309] [310] [311] By mid-December 2020, Pfizer had agreements to supply 300million doses to the European Union,[312] 120million doses to Japan,[313] 40million doses (10million before 2021) to the United Kingdom,[166] 20million doses to Canada,[314] an unspecified number of doses to Singapore,[315] and 34.4million doses to Mexico.[316] Fosun also has agreements to supply 10million doses to Hong Kong and Macau.[317]

Pfizergate investigation

See main article: Pfizergate. Accounts of how Pfizer's got its way into a large deal to provide 1.8 billion doses of its vaccine to the European Union were described by The New York Times as "a striking alignment of political survival and corporate hustle".[318] Shots worth €4 billion were reportedly wasted before the deal was re-negotiated. In early 2023, Belgian prosecutors began investigating European Commission President Ursula von der Leyen and Pfizer CEO Albert Bourla. The case was taken over in 2024 by the European Public Prosecutor's Office citing "interference in public functions, destruction of SMS, corruption and conflict of interest."[319]

Access

Pfizer has been accused of hindering vaccine equity. In 2021, Pfizer delivered only 39% of the contractually agreed doses to the COVAX programme, a number that equals 1.5% of all vaccines produced by Pfizer. The company sold 67% of their doses to high-income countries and sold none directly to low-income countries.[320]

Pfizer actively lobbied against the temporary lift of intellectual property rights which would allow the vaccine to be produced by others without having to pay a royalty fee.[321] [322]

Misinformation

See also: COVID-19 misinformation. Videos on video-sharing platforms circulated around May 2021 showing people having magnets stick to their arms after receiving the vaccine, purportedly demonstrating the conspiracy theory that vaccines contain microchips, but these videos have been debunked.[323] [324] [325] [326]

Further reading

  • Barda N, Dagan N, Ben-Shlomo Y, Kepten E, Waxman J, Ohana R, Hernán MA, Lipsitch M, Kohane I, Netzer D, Reis BY, Balicer RD . Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting . The New England Journal of Medicine . 385 . 12 . 1078–1090 . September 2021 . 34432976 . 8427535 . 10.1056/NEJMoa2110475 . doi . free .
  • Web site: Assessment report: Comirnaty . . . 19 February 2021 . 5 September 2022 .
  • News: How the Pfizer-BioNTech Vaccine Works . . Corum J, Zimmer C . 7 May 2021 . 25 January 2022 . https://web.archive.org/web/20220125103532/https://www.nytimes.com/interactive/2020/health/pfizer-biontech-covid-19-vaccine.html . 25 January 2022 . live .
  • Dickerman BA, Gerlovin H, Madenci AL, Kurgansky KE, Ferolito BR, Figueroa Muñiz MJ, Gagnon DR, Gaziano JM, Cho K, Casas JP, Hernán MA . Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines in U.S. Veterans . The New England Journal of Medicine . 386 . 2 . 105–115 . January 2022 . 34942066 . 8693691 . 10.1056/nejmoa2115463 . doi . free .
  • Levin EG, Lustig Y, Cohen C, Fluss R, Indenbaum V, Amit S, Doolman R, Asraf K, Mendelson E, Ziv A, Rubin C, Freedman L, Kreiss Y, Regev-Yochay G . Waning Immune Humoral Response to BNT162b2 Covid-19 Vaccine over 6 Months . The New England Journal of Medicine . 385 . 24 . e84 . December 2021 . 34614326 . 8522797 . 10.1056/NEJMoa2114583 . doi . free .
  • Mevorach D, Anis E, Cedar N, Bromberg M, Haas EJ, Nadir E, Olsha-Castell S, Arad D, Hasin T, Levi N, Asleh R, Amir O, Meir K, Cohen D, Dichtiar R, Novick D, Hershkovitz Y, Dagan R, Leitersdorf I, Ben-Ami R, Miskin I, Saliba W, Muhsen K, Levi Y, Green MS, Keinan-Boker L, Alroy-Preis S . Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel . The New England Journal of Medicine . 385 . 23 . 2140–2149 . December 2021 . 34614328 . 8531987 . 10.1056/NEJMoa2109730 . doi . free .
  • Web site: A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals . November 2020 . Pfizer . 12 June 2021 . 6 December 2021 . https://web.archive.org/web/20211206133704/https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf . dead .
  • Background document on the mRNA vaccine BNT162b2 (Pfizer–BioNTech) against COVID-19: background document to the WHO interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under emergency use listing, 14 January 2021 . ((World Health Organization)) . 2021 . World Health Organization (WHO) . WHO/2019-nCoV/vaccines/SAGE_recommendation/BNT162b2/background/2021.1 . 10665/338671 . free .

External links

Notes and References

  1. Web site: Comirnaty. 25 January 2021. Therapeutic Goods Administration (TGA). 25 January 2021. 1 February 2021. https://web.archive.org/web/20210201143845/https://www.tga.gov.au/apm-summary/comirnaty. live.
  2. Web site: Comirnaty (BNT162b2 [mRNA]) COVID-19 Vaccine Product Information ]. Therapeutic Goods Administration (TGA) . PDF . 11 May 2022 . 25 January 2021 . 2 February 2021 . https://web.archive.org/web/20210202073852/https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2021-PI-01092-1 . live .
  3. Web site: AusPAR: Tozinameran . Therapeutic Goods Administration (TGA) . 8 February 2022 . 24 March 2022 . 24 March 2022 . https://web.archive.org/web/20220324045146/https://www.tga.gov.au/auspar/auspar-tozinameran . live .
  4. Web site: COVID-19 vaccine: Pfizer Australia - Comirnaty BNT162b2 (mRNA) - approved for use in individuals 12 years and older . Therapeutic Goods Administration (TGA) . 27 August 2021 . https://web.archive.org/web/20210723021746/https://www.tga.gov.au/covid-19-vaccine-pfizer-australia-comirnaty-bnt162b2-mrna-approved-use-individuals-12-years-and-older. 23 July 2021 . 22 October 2021 . live .
  5. Web site: TGA Provisional Approval of Pfizer-BioNTech COVID-19 vaccine to include 12-15 years age group . Therapeutic Goods Administration (TGA) . 23 July 2021 . 22 October 2021 . 22 October 2021 . https://web.archive.org/web/20211022055513/https://www.tga.gov.au/tga-provisional-approval-pfizer-biontech-covid-19-vaccine-include-12-15-years-age-group . live .
  6. Web site: AusPAR: Tozinameran (mRNA Covid 19 vaccine) . Therapeutic Goods Administration (TGA) . 13 December 2021 . 23 March 2022 . 23 March 2022 . https://web.archive.org/web/20220323032230/https://www.tga.gov.au/auspar/auspar-tozinameran-mrna-covid-19-vaccine . live .
  7. Web site: Comirnaty original/Omicron BA.1 COVID-19 Vaccine | Therapeutic Goods Administration (TGA) . 8 November 2022 .
  8. Web site: Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine . Therapeutic Goods Administration (TGA) . 27 January 2023 . 8 April 2023.
  9. Web site: Pfizer) Labelling Exemption (No.2) 2021 . Therapeutic Goods Administration (TGA) . 21 June 2022 . 8 April 2023.
  10. Web site: Comirnaty Omicron XBB.1.5 . Australian Public Assessment Reports (AusPAR), Department of Health and Aged Care, Therapeutic Goods Administration . Australian Government .
  11. Web site: Comirnaty Original/Omicron BA.4-5 . Australian Public Assessment Reports (AusPAR), Department of Health and Aged Care, Therapeutic Goods Administration . Australian Government .
  12. News: Brazil approves Pfizer's COVID-19 shot, but has none to use . 20 November 2021 . Reuters . 23 February 2021 . 20 November 2021 . https://web.archive.org/web/20211120225949/https://www.reuters.com/business/healthcare-pharmaceuticals/brazil-approves-pfizers-covid-19-shot-has-none-use-2021-02-23/ . live .
  13. News: Anvisa concede primeiro registro definitivo para vacina contra a Covid-19 nas Américas . Anvisa grants first definitive registration for Covid-19 vaccine in the Americas . Portuguese . 20 November 2021 . Federal government of Brazil . 23 February 2021 . 20 November 2021 . https://web.archive.org/web/20211120225955/https://www.gov.br/pt-br/noticias/saude-e-vigilancia-sanitaria/2021/02/anvisa-concede-primeiro-registro-definitivo-para-vacina-contra-a-covid-19-nas-americas . live .
  14. Web site: Summary Basis of Decision (SBD) for Comirnaty . . 23 October 2014 . 29 May 2022 . 30 May 2022 . https://web.archive.org/web/20220530051906/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00510&lang=en . live .
  15. Web site: Comirnaty (tozinameran) . . 9 December 2020 . 31 May 2022 . 9 May 2022 . https://web.archive.org/web/20220509183741/https://covid-vaccine.canada.ca/comirnaty/product-details . live .
  16. Web site: Summary Basis of Decision (SBD) for Comirnaty Omicron XBB.1.5 . Drug and Health Products Portal . 1 September 2012 . 11 December 2023.
  17. Web site: Regulatory approval of Pfizer/BioNTech vaccine for COVID-19 . Medicines and Healthcare products Regulatory Agency (MHRA) . 27 September 2021 . 24 October 2021 . 19 January 2021 . https://web.archive.org/web/20210119041847/https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19 . live .
  18. Web site: Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine . Medicines and Healthcare products Regulatory Agency (MHRA) . 31 December 2020 . 8 January 2021 . 26 February 2021 . https://web.archive.org/web/20210226081445/https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/conditions-of-authorisation-for-pfizerbiontech-covid-19-vaccine . live .
  19. Web site: Comirnaty 30 micrograms/dose concentrate for dispersion for injection 12+ years COVID-19 mRNA Vaccine (nucleoside modified) - Summary of Product Characteristics (SmPC) . (emc) . 4 February 2022 . 4 February 2022 . https://web.archive.org/web/20220204195605/https://www.medicines.org.uk/emc/product/12740/smpc . live .
  20. Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age . U.S. Food and Drug Administration (FDA) . 17 June 2022 . 17 June 2022 . 17 June 2022 . https://web.archive.org/web/20220617134729/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children . live .
  21. Web site: Pfizer-Biontech COVID-19 Vaccine- bnt162b2 injection, suspension . DailyMed . 24 October 2021 . 16 November 2020 . https://web.archive.org/web/20201116124118/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=908ecbe7-2f1b-42dd-94bf-f917ec3c5af8 . live .
  22. Web site: Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 12 Years of Age and Older (Purple Cap) . U.S. Centers for Disease Control and Prevention (CDC) . 24 May 2022 . 14 July 2022 .
  23. Web site: Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 6 Months Through 4 Years of Age . U.S. Centers for Disease Control and Prevention (CDC) . 21 June 2022 . 14 July 2022 .
  24. Web site: Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 5 Through 11 Years of Age . U.S. Centers for Disease Control and Prevention (CDC) . 24 May 2022 . 14 July 2022 .
  25. Web site: Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 12 Years of Age and Older (Gray Cap) . U.S. Centers for Disease Control and Prevention (CDC) . 24 May 2022 . 14 July 2022 .
  26. Web site: Pfizer-BioNTech COVID-19 Vaccine- bnt162b2 injection, suspension . DailyMed . 24 October 2021 . 21 October 2021 . https://web.archive.org/web/20211021044910/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=196608f2-21c1-4236-b3e1-06637f7be060 . live .
  27. Web site: Comirnaty- covid-19 vaccine, mrna injection, suspension . DailyMed . 4 February 2022 . 4 February 2022 . https://web.archive.org/web/20220204195549/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=48c86164-de07-4041-b9dc-f2b5744714e5 . live .
  28. News: South Africa approves Pfizer Covid-19 vaccine for emergency use. 16 March 2021 . BusinessTech . 18 March 2021. 18 March 2021. https://web.archive.org/web/20210318184922/https://businesstech.co.za/news/trending/476360/south-africa-approves-pfizer-covid-19-vaccine-for-emergency-use/. live.
  29. Web site: Nkanjeni U . Pfizer-BioNTec approved for emergency use in SA: here is what you need to know about the vaccine. 18 March 2021 . 19 March 2021. TimesLIVE. 19 April 2021. https://web.archive.org/web/20210419054615/https://www.timeslive.co.za/news/south-africa/2021-03-18-pfizer-biontec-approved-for-emergency-use-in-sa-here-is-what-you-need-to-know-about-the-vaccine/. live.
  30. Web site: Updates to the Prescribing Medicines in Pregnancy database . Therapeutic Goods Administration (TGA) . 21 December 2022 . 2 January 2023.
  31. Web site: Comirnaty EPAR. 18 June 2022. European Medicines Agency (EMA). 21 December 2020 . https://web.archive.org/web/20220618041319/https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty. 18 June 2022. live.
  32. News: 11 November 2020. What you need to know about BioNTech – the European company behind Pfizer's Covid-19 vaccine. CNBC. 14 January 2021. Browne R. 4 March 2021. https://web.archive.org/web/20210304192058/https://www.cnbc.com/2020/11/11/biontech-the-european-company-behind-pfizers-covid-19-vaccine.html. live.
  33. Walsh EE, Frenck RW, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Lyke KE, Raabe V, Dormitzer PR, Jansen KU, Şahin U, Gruber WC . Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates . . October 2020 . 383 . 25 . 2439–50 . 33053279 . 7583697 . 10.1056/NEJMoa2027906 . free . doi . 0028-4793 .
  34. Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals . ClinicalTrials.gov . 30 April 2020 . 5 August 2021 . 11 October 2020 . https://web.archive.org/web/20201011084828/https://clinicaltrials.gov/ct2/show/NCT04368728/ . live .
  35. News: Palca J . Pfizer says experimental COVID-19 vaccine is more than 90% effective . NPR.org . NPR . 9 November 2020 . 9 November 2020 . 9 November 2020 . https://web.archive.org/web/20201109130110/https://www.npr.org/sections/health-shots/2020/11/09/933006651/pfizer-says-experimental-covid-19-vaccine-is-more-than-90-effective . live .
  36. Web site: Ellis R . CDC: Gap Between Vaccine Doses Could Be 6 Weeks . 22 January 2021 . 8 July 2021 . WebMD . 4 May 2021 . https://web.archive.org/web/20210504162757/https://www.webmd.com/vaccines/covid-19-vaccine/news/20210122/cdc-gap-between-vaccine-doses-could-be-6-weeks . live .
  37. News: Canada vaccine panel recommends 4 months between COVID doses . ABC News . 4 March 2021 . 9 July 2021 . 26 July 2021 . https://web.archive.org/web/20210726011545/https://abcnews.go.com/International/wireStory/canada-vaccine-panel-recommends-months-covid-doses-76239947 . live .
  38. Public Health Agency of Canada . Recommendations on the use of COVID-19 vaccines . Health Canada . 2 July 2021 . 9 July 2021 . 23 June 2021 . https://web.archive.org/web/20210623231743/https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines/recommendations-use-covid-19-vaccines-en.pdf . live .
  39. Update on our COVID-19 vaccine development program with BNT162b2 . PDF . . 2 December 2020 . 12 December 2020 . 3 December 2020 . https://web.archive.org/web/20201203004920/https://investors.biontech.de/static-files/53f0968a-279b-4f82-a2fc-d67dcb6e4e91 . live.
  40. Web site: Herper M . Covid-19 vaccine from Pfizer and BioNTech is strongly effective, early data from large trial indicate . . 9 November 2020 . 9 November 2020 . 9 November 2020 . https://web.archive.org/web/20201109114554/https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/ . live .
  41. Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study . BioNTech . 1 April 2021 . 11 April 2021 . 4 April 2021 . https://web.archive.org/web/20210404130905/https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-confirm-high-efficacy-and-no-serious-safety . live .
  42. Web site: 19 November 2021. Pfizer-BioNTech COVID-19 Vaccine (also known as Comirnaty) Overview and Safety. https://web.archive.org/web/20211206135118/https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Pfizer-BioNTech.html. 6 December 2021. 27 September 2021. U.S. Centers for Disease Control and Prevention (CDC) . live .
  43. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC . December 2020 . Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine . N Engl J Med . 383 . 27 . 2603–15 . 10.1056/NEJMoa2034577 . 7745181 . 33301246 . free . doi.
  44. Web site: Questions and Answers About Pfizer–BioNTech COVID-19 Vaccine. https://web.archive.org/web/20201223131833/https://www.cvdvaccine-us.com/faqs. 23 December 2020. 16 December 2020. Pfizer . dead .
  45. Web site: 7 December 2020. Coronavirus vaccine. https://web.archive.org/web/20201207150116/https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/. 7 December 2020. 7 December 2020. National Health Service . live .
  46. UK medicines regulator gives approval for first UK COVID-19 vaccine. Medicines and Healthcare products Regulatory Agency (MHRA). 2 December 2020. 2 December 2020. 17 March 2021. https://web.archive.org/web/20210317204122/https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine. live.
  47. News: 2 December 2020. UK approves Pfizer/BioNTech Covid vaccine for rollout next week. The Guardian. 14 December 2020. https://web.archive.org/web/20201202074938/https://www.theguardian.com/society/2020/dec/02/pfizer-biontech-covid-vaccine-wins-licence-for-use-in-the-uk. 2 December 2020. Boseley S, Halliday J . live .
  48. Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland. Swiss Agency for Therapeutic Products (Swissmedic). 19 December 2020. 19 December 2020. 10 January 2021. https://web.archive.org/web/20210110142826/https://www.bag.admin.ch/bag/en/home/das-bag/aktuell/medienmitteilungen.msg-id-81761.html. live.
  49. Web site: COVID-19 Vaccine Tracker: Pfizer/BioNTech: BNT162b2. https://web.archive.org/web/20210508175111/https://covid19.trackvaccines.org/vaccines/6/. 8 May 2021. 8 May 2021. . live .
  50. Web site: 3 February 2021. Pfizer–BioNTech COVID-19 Vaccine. https://web.archive.org/web/20210114221304/https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-COVID-19/pfizer-biontech-COVID-19-vaccine. 14 January 2021. 5 February 2021. U.S. Food and Drug Administration (FDA) . live .
  51. Web site: 20 November 2020. F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away. https://web.archive.org/web/20201212023020/https://www.nytimes.com/2020/12/11/health/pfizer-vaccine-authorized.html. 12 December 2020. The New York Times. Thomas K . live .
  52. Web site: Australian Government Department of Health. 24 January 2021. About the Pfizer/BioNTech COVID-19 vaccine. https://web.archive.org/web/20210523030500/https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/learn-about-covid-19-vaccines/about-the-pfizerbiontech-covid-19-vaccine. 23 May 2021. 31 May 2021. Australian Government Department of Health . live .
  53. Web site: 23 August 2021. Comirnaty. https://web.archive.org/web/20211203134846/https://www.fda.gov/vaccines-blood-biologics/comirnaty. 3 December 2021. 23 August 2021. U.S. Food and Drug Administration (FDA). STN: 125742 . live .
  54. Book: Rosales-Mendoza S, Wong-Arse A, de Lourdes Betancourt-Mendiola M . Rosales-Mendoza S, Comas-García M, González-Ortega O . Biomedical Innovations to Combat COVID-19 . 2021 . Academic Press . London . 978-0-323-90248-9 . 129–152 . 8. RNA based vaccines against SARS COV-2 . 19 December 2021 . 11 January 2022 . https://web.archive.org/web/20220111213952/https://books.google.com/books?id=zcwnEAAAQBAJ&q=COVID-19+vaccine+elsevier . live .
  55. Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose . U.S. Food and Drug Administration . 31 August 2022 . 1 September 2022.
  56. Web site: Fall 2022 COVID-19 Vaccine Strain Composition Selection Recommendation . PDF . U.S. Food and Drug Administration . 30 June 2022 . Marks P . 1 September 2022.
  57. Web site: Interim Clinical Considerations for COVID-19 Vaccines: Bivalent Boosters . U.S. Centers for Disease Control and Prevention (CDC) . 1 September 2022 . 1 September 2022 . Hall E, Twentyman E .
  58. CDC Recommends the First Updated COVID-19 Booster . U.S. Centers for Disease Control and Prevention (CDC) . 1 September 2022 . 2 September 2022.
  59. Web site: Comirnaty Original/Omicron BA.1 15/15 micrograms per dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) - Summary of Product Characteristics (SmPC) . (emc) . 5 September 2022 . 21 October 2022.
  60. Pfizer/BioNTech bivalent COVID-19 booster approved by UK medicines regulator . Medicines and Healthcare products Regulatory Agency (MHRA) . 3 September 2022 . 5 September 2022.
  61. Web site: Regulatory approval of Pfizer/BioNTech bivalent Original/Omicron booster vaccine . Medicines and Healthcare products Regulatory Agency (MHRA) . 3 September 2022 . 5 September 2022.
  62. Pfizer–BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum . PDF . U.S. Food and Drug Administration (FDA) . 14 December 2020 . 14 December 2020 . 29 January 2021 . https://web.archive.org/web/20210129152900/https://www.fda.gov/media/144416/download . live .
  63. News: Pfizer vaccine second dose has 'sweet spot' after eight weeks, UK scientists say . 22 July 2021 . . https://web.archive.org/web/20211118180256/https://www.theguardian.com/world/2021/jul/23/pfizer-vaccine-second-dose-has-sweet-spot-after-eight-weeks-uk-scientists-say. 18 November 2021 . 26 July 2021 . live .
  64. News: Sweden: 5th COVID-19 shot to people over 65, pregnant women . ABC News . 24 May 2022 . 18 June 2022 . . 18 June 2022 . https://web.archive.org/web/20220618042656/https://abcnews.go.com/Health/wireStory/sweden-5th-covid-19-shot-people-65-pregnant-84929370 . live .
  65. News: Vanttinen P . Finland recommends fifth COVID booster for vulnerable patients . . 17 June 2022 . 18 June 2022 . 18 June 2022 . https://web.archive.org/web/20220618043414/https://www.euractiv.com/section/politics/short_news/finland-recommends-fifth-covid-booster-for-vulnerable-patients/ . live .
  66. This is a type of study where researchers recruit two groups: people who test positive for the disease (cases) and those who test negative (controls) (Vandenbroucke 2019). They then survey these individuals for factors which may have affected whether or not they developed the disease (in this case, vaccination status) (Patel 2020). In the case of Lopez Bernal et al, they also assessed which variant each "case" contracted (e.g. alpha [B.1.1.7] or delta [B.1.617.2]) using both RT-PCR testing and whole genome sequencing. To evaluate efficacy, the researchers determined how much less likely a person was to contract each variant based on their vaccination status. In this case, a person who received two doses of the Pfizer vaccine was 93.7% less likely to contract the alpha variant and 88.0% less likely to contract the delta variant, when compared to an unvaccinated person.
    • Vandenbroucke JP, Pearce N . Test-Negative Designs: Differences and Commonalities with Other Case-Control Studies with "Other Patient" Controls . Epidemiology . 30 . 6 . 838–844 . November 2019 . 31430265 . 10.1097/EDE.0000000000001088 . 201117050 . 31 August 2021 . 21 September 2021 . https://web.archive.org/web/20210921231430/https://researchonline.lshtm.ac.uk/id/eprint/4654052/1/Vandenbroucke-Pearce-2019-Test-negative-designs.pdf . live .
    • Patel MM, Jackson ML, Ferdinands J . Postlicensure Evaluation of COVID-19 Vaccines . JAMA . 324 . 19 . 1939–40 . November 2020 . 33064144 . 10.1001/jama.2020.19328 . 222819843 . free . doi .
  67. Lopez Bernal J, Andrews N, Gower C, Gallagher E, Simmons R, Thelwall S, Stowe J, Tessier E, Groves N, Dabrera G, Myers R, Campbell CN, Amirthalingam G, Edmunds M, Zambon M, Brown KE, Hopkins S, Chand M, Ramsay M . Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant . The New England Journal of Medicine . 385 . 7 . 585–594 . August 2021 . 34289274 . 8314739 . 10.1056/NEJMoa2108891 . free . doi .
  68. Evans SJ, Jewell NP . Vaccine Effectiveness Studies in the Field . The New England Journal of Medicine . 385 . 7 . 650–651 . August 2021 . 34289269 . 8314732 . 10.1056/NEJMe2110605 . free . doi .
  69. Fowlkes A, Gaglani M, Groover K, Thiese MS, Tyner H, Ellingson K . 27 August 2021 . Effectiveness of COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Frontline Workers Before and During B.1.617.2 (Delta) Variant Predominance — Eight U.S. Locations, December 2020–August 2021 . MMWR. Morbidity and Mortality Weekly Report . 70 . 34 . 1167–9 . 10.15585/mmwr.mm7034e4 . 34437521 . 8389394 . free . 15 September 2021 . 5 February 2022 . https://web.archive.org/web/20220205122036/https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7034e4-H.pdf . live .
  70. Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R, Dean NE, Halloran ME, Huang Y, Fleming TR, Gilbert PB, DeGruttola V . 12 September 2020 . COVID-19 vaccine trials should seek worthwhile efficacy . The Lancet . 396 . 10253 . 741–743 . 10.1016/S0140-6736(20)31821-3 . 0140-6736 . 32861315 . 7832749 . WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. Guidance from the US Food and Drug Administration includes this lower limit of 30% as a criterion for vaccine licensure..
  71. Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, Subbarao K, Kent SJ, Triccas JA, Davenport MP . May 2021 . Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection . Nature Medicine . 27 . 7 . 1205–11 . 10.1038/s41591-021-01377-8 . 34002089 . 234769053 . free . doi .
  72. Briefing . SARS-CoV-2 variants of concern and variants under investigation in England, technical briefing 28 . GOV-10349 . Public Health England . 12 November 2021 . PDF . 18 November 2021 . 12 November 2021 . https://web.archive.org/web/20211112131823/https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1033101/Technical_Briefing_28_12_Nov_2021.pdf . live . Figures 21 and 22 .
  73. Thomas SJ, Moreira ED, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Polack FP, Zerbini C, Bailey R, Swanson KA, Xu X, Roychoudhury S, Koury K, Bouguermouh S, Kalina WV, Cooper D, Frenck RW, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Yang Q, Liberator P, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Gruber WC, Jansen KU . Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months . The New England Journal of Medicine . September 2021 . 34525277 . 10.1056/nejmoa2110345 . 8461570 . free . doi . 385 . 19 . 1761–1773 .
  74. Chemaitelly H, Tang P, Hasan MR, AlMukdad S, Yassine HM, Benslimane FM, Al Khatib HA, Coyle P, Ayoub HH, Al Kanaani Z, Al Kuwari E . 6 October 2021 . Waning of BNT162b2 Vaccine Protection against SARS-CoV-2 Infection in Qatar . New England Journal of Medicine . 385 . 24 . e83 . 10.1056/NEJMoa2114114 . 0028-4793 . 8522799 . 34614327 . 9 November 2021 . 29 January 2022 . https://web.archive.org/web/20220129213331/https://www.nejm.org/doi/10.1056/NEJMoa2114114 . live .
  75. News: Howard J . Booster dose of Pfizer/BioNTech coronavirus vaccine shows 95.6% efficacy in Phase 3 trial, companies say . 10 November 2021 . CNN . 21 October 2021 . 9 November 2021 . https://web.archive.org/web/20211109182843/https://edition.cnn.com/2021/10/21/health/pfizer-booster-dose-efficacy-wellness-bn/index.html . live .
  76. 21 October 2021 . Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine . BioNTech . 10 November 2021 . 9 November 2021 . https://web.archive.org/web/20211109194335/https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-announce-phase-3-trial-data-showing-high/ . live .
  77. 8 December 2021 . Pfizer And BioNTech Provide Update On Omicron Variant . New York City and Mainz . Pfizer . 8 December 2021 . 21 December 2021 . https://web.archive.org/web/20211221074359/https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-omicron-variant . live .
  78. News: Pfizer shot less effective against hospitalisation in South Africa - study . Reuters . Winning A, Roelf W . 14 December 2021 . 14 December 2021 . 21 December 2021 . https://web.archive.org/web/20211221081929/https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-vaccine-protecting-against-hospitalisation-during-omicron-wave-study-2021-12-14/ . live .
  79. Web site: Bivalent booster effectiveness against severe COVID-19 outcomes in Finland, September 2022–January 2023 . 2 March 2023 . 8 March 2023 . ResearchGate .
  80. News: Smith K . New CDC guidance recommends pregnant people get the COVID-19 vaccine . CBS News . 24 April 2021 . 24 April 2021 . 24 April 2021 . https://web.archive.org/web/20210424112007/https://www.cbsnews.com/news/pregnant-women-covid-vaccine-cdc-guidance/ . live .
  81. Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu R, Chang KT, Ellington SR, Burkel VK, Smoots AN, Green CJ, Licata C, Zhang BC, Alimchandani M, Mba-Jonas A, Martin SW, Gee JM, Meaney-Delman DM . Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons . N Engl J Med . 384. 24. 2273–2282. April 2021 . 33882218 . 10.1056/NEJMoa2104983 . 8117969 . free . doi .
  82. Web site: 4 June 2021. UK regulator approves Pfizer Covid vaccine for 12- to 15-year-olds. 4 June 2021. . Boseley S . 4 June 2021. https://web.archive.org/web/20210604121001/https://www.theguardian.com/world/2021/jun/04/uk-regulator-approves-pfizer-covid-vaccine-for-12-to-15-year-olds. live.
  83. News: Reynolds J. Pfizer vaccine approved for use in children aged 12 to 15 in the UK. The Times. 4 June 2021. 4 June 2021. 0140-0460. 4 June 2021. https://web.archive.org/web/20210604141606/https://www.thetimes.co.uk/article/pfizer-vaccine-approved-for-use-in-children-aged-12-to-15-in-the-uk-j5fm2r825. live.
  84. Torjesen I . Covid-19: Pfizer-BioNTech vaccine is "likely" responsible for deaths of some elderly patients, Norwegian review finds . BMJ . 373 . n1372 . May 2021 . 34045236 . 10.1136/bmj.n1372 . 235204094 . free .
  85. Web site: 28 April 2021. Immunocompromised patients and COVID-19 vaccines. NSW Health. 2 June 2021. 20 May 2021. https://web.archive.org/web/20210520100933/https://aci.health.nsw.gov.au/__data/assets/pdf_file/0009/645750/Evidence-check-Immunocompromised-patients-COVID-19-vaccines.pdf. live.
  86. News: Lovelace Jr B . Pfizer says its Covid vaccine is safe and generates robust immune response in kids ages 5 to 11 . CNBC . 20 September 2021 . 26 November 2021 . 27 October 2021 . https://web.archive.org/web/20211027150003/https://www.cnbc.com/2021/09/20/pfizer-covid-vaccine-is-safe-generates-robust-immune-response-in-kids-ages-5-to-11.html . live .
  87. Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years . Pfizer . 20 September 2021 . 26 November 2021 . 25 November 2021 . https://web.archive.org/web/20211125232207/https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results . live .
  88. Rutkowski K, Mirakian R, Till S, Rutkowski R, Wagner A. June 2021. Adverse reactions to COVID-19 vaccines: A practical approach. Clinical and Experimental Allergy. 51. 6. 770–777. 10.1111/cea.13880. 8250847. 33813758.
  89. January 2021. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine - United States, December 14-23, 2020. MMWR. Morbidity and Mortality Weekly Report. 70. 2. 46–51. 10.15585/mmwr.mm7002e1. 7808711. 33444297 . free . live . ((COVID-19 Response Team)) . https://web.archive.org/web/20220424222532/https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7002e1-H.pdf . 24 April 2022.
  90. Web site: 28 January 2021. COVID-19 vaccine safety update: Comirnaty. https://web.archive.org/web/20210602213346/https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-comirnaty-28-january-2021_en.pdf. 2 June 2021. 30 January 2021. European Medicines Agency (EMA) . live .
  91. Web site: 9 December 2020. MHRA warning after allergic reactions in NHS staff given COVID-19 vaccine. https://web.archive.org/web/20201209163321/https://www.gponline.com/mhra-warning-allergic-reactions-nhs-staff-given-covid-19-vaccine/article/1702322. 9 December 2020. 9 December 2020. GP. Bostock N . live .
  92. News: 9 December 2020. Britain warns against Pfizer vaccine for people with history of 'significant' allergic reactions. The Washington Post. 9 December 2020. https://web.archive.org/web/20201209195847/https://www.washingtonpost.com/world/pfizer-allergic-warnings-vaccine/2020/12/09/4e79ec72-3a16-11eb-aad9-8959227280c4_story.html. 9 December 2020. Booth W, Cunningham E . live .
  93. Cabanillas B, Akdis CA, Novak N. June 2021. Allergic reactions to the first COVID-19 vaccine: A potential role of polyethylene glycol?. Allergy. 76. 6. 1617–1618. 10.1111/all.14711. 33320974. free. 229284320. doi .
  94. Web site: 12 December 2020. Pfizer–BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies. https://web.archive.org/web/20201222224308/https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74543a-eng.php. 22 December 2020. 21 December 2020. . live .
  95. News: 2 June 2021. Israel sees probable link between Pfizer vaccine and myocarditis cases. Reuters. 3 June 2021. https://web.archive.org/web/20210625045743/https://www.reuters.com/world/middle-east/israel-sees-probable-link-between-pfizer-vaccine-small-number-myocarditis-cases-2021-06-01/. 25 June 2021. Heller J . live .
  96. Web site: Clinical Considerations: Myocarditis after mRNA COVID-19 Vaccines . U.S. Centers for Disease Control and Prevention (CDC) . 27 June 2021 . 27 June 2021 . https://web.archive.org/web/20210627075945/https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html . live .
  97. Oster ME, Shay DK, Su JR, Gee J, Creech CB, Broder KR, Edwards K, Soslow JH, Dendy JM, Schlaudecker E, Lang SM, Barnett ED, Ruberg FL, Smith MJ, Campbell MJ, Lopes RD, Sperling LS, Baumblatt JA, Thompson DL, Marquez PL, Strid P, Woo J, Pugsley R, Reagan-Steiner S, DeStefano F, Shimabukuro TT . January 2022 . Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021 . JAMA . 327 . 4 . 331–340 . 10.1001/jama.2021.24110 . 35076665 . free . doi . 8790664 .
  98. Web site: National Center for Immunization and Respiratory Diseases . Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination . U.S. Centers for Disease Control and Prevention (CDC) . 2 July 2021 . 23 June 2021 . 3 July 2021 . https://web.archive.org/web/20210703101038/https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html . live .
  99. Web site: STIKO empfiehlt Aspiration bei COVID-19-Impfung als Vorsichtsmaßnahme . STIKO recommends aspiration for COVID-19 vaccination as precautionary measure . 18 February 2022 . 25 September 2022 . Im Tiermodell seien nach direkter intravenöser Gabe eines mRNA-Impfstoffs Perimyokarditiden aufgetreten. . In an animal model, perimyocarditis had occurred after direct intravenous administration of an mRNA vaccine. . de . Deutsches Ärzteblatt.
  100. Vogel AB, Kanevsky I, Che Y, Swanson KA, Muik A, Vormehr M, Kranz LM, Walzer KC, Hein S, Güler A, Loschko J, Maddur MS, Ota-Setlik A, Tompkins K, Cole J, Lui BG, Ziegenhals T, Plaschke A, Eisel D, Dany SC, Fesser S, Erbar S, Bates F, Schneider D, Jesionek B, Sänger B, Wallisch AK, Feuchter Y, Junginger H, Krumm SA, Heinen AP, Adams-Quack P, Schlereth J, Schille S, Kröner C, de la Caridad Güimil Garcia R, Hiller T, Fischer L, Sellers RS, Choudhary S, Gonzalez O, Vascotto F, Gutman MR, Fontenot JA, Hall-Ursone S, Brasky K, Griffor MC, Han S, Su AA, Lees JA, Nedoma NL, Mashalidis EH, Sahasrabudhe PV, Tan CY, Pavliakova D, Singh G, Fontes-Garfias C, Pride M, Scully IL, Ciolino T, Obregon J, Gazi M, Carrion R, Alfson KJ, Kalina WV, Kaushal D, Shi PY, Klamp T, Rosenbaum C, Kuhn AN, Türeci Ö, Dormitzer PR, Jansen KU, Sahin U . BNT162b vaccines protect rhesus macaques from SARS-CoV-2 . Nature . 592 . 7853 . 283–289 . April 2021 . 33524990 . 10.1038/s41586-021-03275-y. 0028-0836 . 2021Natur.592..283V . free. doi .
  101. Gaebler C, Nussenzweig MC . All eyes on a hurdle race for a SARS-CoV-2 vaccine . Nature . 586 . 7830 . 501–2 . October 2020 . 33077943 . 10.1038/d41586-020-02926-w . 2020Natur.586..501G . 224808629 . free . doi .
  102. Web site: World Health Organization (WHO) . Messenger RNA encoding the full-length SARS-CoV-2 spike glycoprotein . September 2020 . https://web.archive.org/web/20210105162941/https://mednet-communities.net/inn/db/media/docs/11889.doc . 5 January 2021 . DOC . WHO MedNet . 16 December 2020 . live .
  103. Pallesen J, Wang N, Corbett KS, Wrapp D, Kirchdoerfer RN, Turner HL, Cottrell CA, Becker MM, Wang L, Shi W, Kong WP, Andres EL, Kettenbach AN, Denison MR, Chappell JD, Graham BS, Ward AB, McLellan JS . Immunogenicity and structures of a rationally designed prefusion MERS-CoV spike antigen . Proceedings of the National Academy of Sciences of the United States of America . 114 . 35 . E7348–E7357 . August 2017 . 28807998 . 5584442 . 10.1073/pnas.1707304114 . free . doi . 2017PNAS..114E7348P .
  104. Orlandini von Niessen AG, Poleganov MA, Rechner C, Plaschke A, Kranz LM, Fesser S, Diken M, Löwer M, Vallazza B, Beissert T, Bukur V, Kuhn AN, Türeci Ö, Sahin U . Improving mRNA-Based Therapeutic Gene Delivery by Expression-Augmenting 3' UTRs Identified by Cellular Library Screening . Molecular Therapy . 27 . 4 . April 2019 . 824–836 . 30638957 . 6453560 . 10.1016/j.ymthe.2018.12.011 .
  105. Web site: Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine . Medicines and Healthcare products Regulatory Agency (MHRA) . 10 December 2020 . 21 December 2020 . 15 March 2021 . https://web.archive.org/web/20210315192413/https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-healthcare-professionals-on-pfizerbiontech-covid-19-vaccine . live .
  106. Comirnaty: Product Information . 23 December 2020 . European Medicines Agency (EMA) . 24 December 2020 . https://web.archive.org/web/20201224122112/https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf . live .
  107. de Vrieze J . Suspicions grow that nanoparticles in Pfizer's COVID-19 vaccine trigger rare allergic reactions . 10.1126/science.abg2359 . free . doi . Science . 21 December 2020 .
  108. Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection . 23 April 2021 . Regulation 174 . Medicines and Healthcare products Regulatory Agency (MHRA) . 15 December 2020 . 16 December 2020 . https://web.archive.org/web/20201216143412/https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/944544/COVID-19_mRNA_Vaccine_BNT162b2__UKPAR___PFIZER_BIONTECH__15Dec2020.pdf . live .
  109. News: Rabson M . From science to syringe: COVID-19 vaccines are miracles of science and supply chains . CTV News . Bell Media . 27 February 2021 . 28 February 2021 . 27 February 2021 . https://web.archive.org/web/20210227181528/https://www.ctvnews.ca/health/coronavirus/from-science-to-syringe-covid-19-vaccines-are-miracles-of-science-and-supply-chains-1.5327003 . live .
  110. News: 23 November 2020. Pfizer's Chesterfield workforce playing a key role in coronavirus vaccine development. St. Louis Post-Dispatch. Gray B. 28 January 2021. 18 January 2021. https://web.archive.org/web/20210118033409/https://www.stltoday.com/business/local/pfizers-chesterfield-workforce-playing-a-key-role-in-coronavirus-vaccine-development/article_2eefc85c-fd51-5d2a-b137-70ca95fff123.html. live.
  111. News: Gosk S . Inside Lab Where Every Pfizer Dose Originates . 5 April 2021 . NBC Nightly News With Lester Holt . NBC News . 1 April 2021 . 2 June 2021 . https://web.archive.org/web/20210602213437/https://www.youtube.com/watch?v=oiLWWAQP_Ls . live . Via YouTube. Gosk's segment on Pfizer begins at 7:10 of the video file.
  112. News: Johnson CY . A vial, a vaccine and hopes for slowing a pandemic – how a shot comes to be . 21 December 2020 . . 17 November 2020 . 21 March 2021 . https://web.archive.org/web/20210321221158/https://www.washingtonpost.com/health/2020/11/17/coronavirus-vaccine-manufacturing/ . live .
  113. News: Hughes M . Andover's piece of the vaccine: Pfizer . The Eagle-Tribune . 20 December 2020 . 28 January 2021 . 26 January 2021 . https://web.archive.org/web/20210126120043/https://www.eagletribune.com/news/merrimack_valley/andovers-piece-of-the-vaccine-pfizer/article_a648be2a-faf4-5639-9a6f-d55de285cce3.html . live .
  114. News: Shamus KJ . Historic journey: Pfizer prepares to deliver 6.4 million doses of COVID-19 vaccines . Detroit Free Press . 13 December 2020 . 28 January 2021 . 29 January 2021 . https://web.archive.org/web/20210129191613/https://www.freep.com/story/news/health/2020/12/13/pfizer-covid-19-vaccines-kalamazoo-michigan/6529215002/ . live .
  115. News: Mullin R . Pfizer, Moderna ready vaccine manufacturing networks . 21 December 2020 . Chemical & Engineering News . American Chemical Society . 25 November 2020 . Washington, D.C. . 11 December 2020 . https://web.archive.org/web/20201211230548/https://cen.acs.org/business/outsourcing/Pfizer-Moderna-ready-vaccine-manufacturing/98/i46 . live .
  116. News: Panetta A . Canada to start receiving U.S. shipments of Pfizer-BioNTech vaccine next week . CBC News . CBC/Radio-Canada . 30 April 2021 . 4 May 2021 . 5 May 2021 . https://web.archive.org/web/20210505015321/https://www.cbc.ca/news/politics/canada-pfizer-biontech-covid-19-vaccine-u-s-1.6010321 . live .
  117. Statement on Manufacturing. 5 February 2021. BioNTech. 1 February 2021. 7 February 2021. https://web.archive.org/web/20210207081647/https://investors.biontech.de/news-releases/news-release-details/statement-manufacturing. live.
  118. News: Kresge N . BioNTech Raises Covid Vaccine Target to 2.5 Billion Doses . Bloomberg . 30 March 2021 . 11 April 2021 . 11 April 2021 . https://web.archive.org/web/20210411125303/https://www.bloomberg.com/news/articles/2021-03-30/biontech-raises-2021-covid-vaccine-target-to-2-5-billion-doses . live .
  119. News: Weise E . Pfizer expects to cut COVID-19 vaccine production time by close to 50% as production ramps up, efficiencies increase . . 7 February 2021 . 17 February 2021 . 2 June 2021 . https://web.archive.org/web/20210602213357/https://www.usatoday.com/story/news/health/2021/02/07/pfizer-expects-cut-covid-19-vaccine-production-time-almost-50/4423251001/ . live .
  120. BioNTech to Acquire GMP Manufacturing Site to Expand COVID-19 Vaccine Production Capacity in First Half 2021 . 17 September 2020 . 5 February 2021 . BioNTech . 7 February 2021 . https://web.archive.org/web/20210207081616/https://investors.biontech.de/news-releases/news-release-details/biontech-acquire-gmp-manufacturing-site-expand-covid-19-vaccine . live .
  121. News: Solomon E . 'Where the magic happens' – inside BioNTech's innovative vaccine plant . Financial Times . 1 April 2021 . 5 April 2021 . 4 April 2021 . https://web.archive.org/web/20210404050331/https://www.ft.com/content/cf5d6113-3698-4cc7-9d5b-8f0f29fd6a35 . live .
  122. Web site: 23 April 2021. EU approves ramp-up of Pfizer vaccine manufacturing site in Belgium. 25 April 2021. Reuters. 25 April 2021. https://web.archive.org/web/20210425191452/https://www.reuters.com/world/europe/eu-approves-ramp-up-pfizer-vaccine-manufacturing-site-belgium-2021-04-23/. live.
  123. Web site: 23 April 2021. Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna. European Medicines Agency (EMA). 25 April 2021. 25 April 2021. https://web.archive.org/web/20210425205402/https://www.ema.europa.eu/en/news/increase-vaccine-manufacturing-capacity-supply-covid-19-vaccines-biontechpfizer-moderna. live.
  124. Web site: 11 December 2020. Pfizer–BioNTech COVID-19 Vaccine Frequently Asked Questions. 11 May 2021. U.S. Food and Drug Administration. 14 February 2021. https://web.archive.org/web/20210214094008/https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/pfizer-biontech-covid-19-vaccine-frequently-asked-questions. live.
  125. Web site: 8 January 2021. Extra dose from vials of Comirnaty COVID-19 vaccine. 8 January 2021. European Medicines Agency (EMA). 8 January 2021. https://web.archive.org/web/20210108111212/https://www.ema.europa.eu/en/news/extra-dose-vials-comirnaty-covid-19-vaccine. live.
  126. Web site: AIFA, possibile ottenere almeno 6 dosi da ogni flaconcino del vaccino BioNTech/Pfizer. 28 December 2020. 29 December 2020. aifa.gov.it. it-IT. 21 March 2021. https://web.archive.org/web/20210321221154/https://www.aifa.gov.it/-/aifa-possibile-ottenere-almeno-6-dosi-da-ogni-flaconcino-del-vaccino-biontech-pfizer. live.
  127. Web site: Sundhedsstyrelsen opdaterer retningslinje for håndtering af vaccination mod COVID-19 i det generelle vaccinationsprogram . The Danish Health Authority . 20 May 2021 . 21 May 2021 . Danish . The Danish Health Authority updates guidelines on handling of vaccination against COVID-19 in the general vaccination program . 20 May 2021 . https://web.archive.org/web/20210520100828/https://www.sst.dk/da/Nyheder/2021/Sundhedsstyrelsen-opdaterer-retningslinje-for-haandtering-af-vaccination-mod-COVID-19 . live .
  128. Web site: 8 January 2021. Global information about Comirnaty. 16 January 2021. ComirnatyEducation.ie. Pfizer Inc.. 9 January 2021. https://web.archive.org/web/20210109090927/https://www.comirnatyeducation.ie/. live.
  129. Web site: Comirnaty Package Insert. BioNTech Manufacturing GmbH. January 2021. 16 January 2021. 2 June 2021. https://web.archive.org/web/20210602213350/https://www.comirnatyeducation.ie/files/Approved_SmPC_V2.pdf. dead.
  130. News: 22 January 2021. Biden wants to squeeze an extra shot of vaccine out of every Pfizer vial. It won't be easy.. The Washington Post. 29 January 2021. Rowland C. 29 January 2021. https://web.archive.org/web/20210129000610/https://www.washingtonpost.com/business/2021/01/22/pfizer-vaccine-doses-syringes/. live.
  131. Web site: Office of the Commissioner. 19 May 2021. FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available. 17 September 2021. U.S. Food and Drug Administration (FDA). 22 May 2021. https://web.archive.org/web/20210522170356/https://www.fda.gov/news-events/press-announcements/fda-brief-fda-authorizes-longer-time-refrigerator-storage-thawed-pfizer-biontech-covid-19-vaccine. live.
  132. Web site: Office of the Commissioner. 19 May 2021. FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available. https://web.archive.org/web/20210522170356/https://www.fda.gov/news-events/press-announcements/fda-brief-fda-authorizes-longer-time-refrigerator-storage-thawed-pfizer-biontech-covid-19-vaccine. 22 May 2021. 22 May 2021. U.S. Food and Drug Administration (FDA) . live .
  133. Web site: 26 January 2021. Recommendation for an Emergency Use Listing of Tozinameran (Covid-19 Mrna Vaccine (Nucleoside Modified)) Submitted by Biontech Manufacturing Gmbh. World Health Organization (WHO). 31 January 2021. 12 March 2021. https://web.archive.org/web/20210312045036/https://extranet.who.int/pqweb/sites/default/files/documents/TAG-EUL_PublicReport_BioNTech_DEC20.pdf. live.
  134. Web site: Pfizer–BioNTech COVID-19 Vaccine Vaccination Storage & Dry Ice Safety Handling . Pfizer-BioNTech . 17 December 2020 . 24 January 2021 . https://web.archive.org/web/20210124024401/https://www.cvdvaccine-us.com/product-storage-and-dry-ice . live .
  135. News: Deep-freeze hurdle makes Pfizer's vaccine one for the rich . 12 November 2020 . Bloomberg . 10 November 2020 . Vaccine goes bad five days after thawing, requires two shots; Many nations face costly ramp up of cold-chain infrastructure . 22 November 2020 . https://web.archive.org/web/20201122105948/https://www.bloomberg.com/news/articles/2020-11-10/deep-freeze-challenge-makes-pfizer-s-shot-a-vaccine-for-the-rich . live .
  136. News: Pfizer and BioNTech's vaccine poses global logistics challenge. The Guardian. 10 November 2020. https://web.archive.org/web/20201110184815/https://www.theguardian.com/business/2020/nov/10/pfizer-and-biontechs-vaccine-poses-global-logistics-challenge . 10 November 2020 . 10 November 2020. Kollewe J . live .
  137. News: 8 September 2020. Daunting task of distribution exposed as it emerges some vaccines must be 'deep frozen' at −70C. The Telegraph. 10 November 2020. https://web.archive.org/web/20201109121506/https://www.telegraph.co.uk/global-health/science-and-disease/boost-oxford-covid-vaccine-emerges-rivals-must-deep-frozen/. 9 November 2020. Newey S . live .
  138. News: 5 December 2020. How China's COVID-19 could fill the gaps left by Pfizer, Moderna, AstraZeneca. Fortune. McGregor G . 5 December 2020. https://web.archive.org/web/20201212204815/https://fortune.com/2020/12/05/china-covid-19-vaccines-approval-sinovac-sinopharm/. 12 December 2020 . live .
  139. News: 22 November 2020. Pfizer's Vaccine Is Out of the Question as Indonesia Lacks Refrigerators: State Pharma Boss. Jakarta Globe. 5 December 2020. https://web.archive.org/web/20201207124956/https://jakartaglobe.id/business/pfizers-vaccine-is-out-of-the-question-as-indonesia-lacks-refrigerators-state-pharma-boss/. 7 December 2020 . live .
  140. Book: Miller J . 2021 . The Vaccine: Inside the Race to Conquer the COVID-19 Pandemic . London . Welbeck . Paperback . 978-1-80279-124-2 .
  141. Web site: Gates B . 30 April 2020. The vaccine race explained: What you need to know about the COVID-19 vaccine . https://web.archive.org/web/20200514010012/https://www.gatesnotes.com/Health/What-you-need-to-know-about-the-COVID-19-vaccine . 14 May 2020 . 2 May 2020 . The Gates Notes . live .
  142. Web site: 27 April 2020. World Health Organization timeline – COVID-19. https://web.archive.org/web/20200429012212/https://www.who.int/news-room/detail/27-04-2020-who-timeline---covid-19. 29 April 2020. 2 May 2020. World Health Organization (WHO) . live .
  143. News: Gelles D . 10 November 2020 . The Husband-and-Wife Team Behind the Leading Vaccine to Solve Covid-19 . The New York Times . 17 November 2020 . 13 November 2020 . https://web.archive.org/web/20201113115852/https://www.nytimes.com/2020/11/10/business/biontech-covid-vaccine.html. live.
  144. News: The story of mRNA: From a loose idea to a tool that may help curb Covid . 16 May 2021 . . 10 November 2020 . Garde D, Saltzman J . 15 April 2021 . https://web.archive.org/web/20210415010956/https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-once-dismissed-idea-became-a-leading-technology-in-the-covid-vaccine-race/ . live .
  145. Thanh Le T, Andreadakis Z, Kumar A, Gómez Román R, Tollefsen S, Saville M, Mayhew S . The COVID-19 vaccine development landscape . Nature Reviews. Drug Discovery . 19 . 5 . 305–306 . May 2020 . 32273591 . 10.1038/d41573-020-00073-5 . free . doi .
  146. Fauci AS, Lane HC, Redfield RR . Covid-19 – Navigating the Uncharted . The New England Journal of Medicine . 382 . 13 . 1268–69 . March 2020 . 32109011 . 7121221 . 10.1056/nejme2002387 . free . doi .
  147. News: Papadopoulos . 14 December 2020 . Chronologie – So entstand der Corona-Impfstoff von Biontech . Chronology – That's how the Covid-vaccine of Biontech was being developed . . de . 20 December 2020 . 2 December 2020 . https://web.archive.org/web/20201202092744/https://www.swr.de/swraktuell/rheinland-pfalz/corona-impfstoff-chronologie-100.html . live.
  148. News: Ravi V . How Pfizer Crafted Its Own 'Operation Warp Speed' For The COVID-19 Vaccine . 20 November 2021 . Scrip Informa Pharma Intelligence . Informa . 24 June 2021 . 20 November 2021 . https://web.archive.org/web/20211120171844/https://scrip.pharmaintelligence.informa.com/SC144598/How-Pfizer-Crafted-Its-Own-Operation-Warp-Speed-For-The-COVID-19-Vaccine . live.
  149. Lewis LM, Badkar AV, Cirelli D, Combs R, Lerch TF . The Race to Develop the Pfizer-BioNTech COVID-19 Vaccine: From the Pharmaceutical Scientists' Perspective . Journal of Pharmaceutical Sciences . 112 . 3 . 640–647 . March 2023 . 36130677 . 10.1016/j.xphs.2022.09.014 . Elsevier . Amsterdam . 9482796 .
  150. The Price Tags on the COVID-19 Vaccines . 15 March 2021 . 20 June 2021 . Managed Healthcare Executive . 31 . 3 . 1533-9300 . Kaplan DA, Wehrwein P . 23 June 2021 . https://web.archive.org/web/20210623051354/https://www.managedhealthcareexecutive.com/view/the-price-tags-on-the-covid-19-vaccines . live.
  151. Fosun Pharma and BioNTech form COVID-19 vaccine strategic alliance in China . Fosun Pharma . 15 March 2020 . 20 March 2021 . https://web.archive.org/web/20200815194524/https://www.fosunpharma.com/en/news/news-details-3801.html . 15 August 2020 . live.
  152. News: Burger L . BioNTech in China alliance with Fosun over coronavirus vaccine candidate . 10 November 2020 . Reuters . 15 March 2020 . 14 November 2020 . https://web.archive.org/web/20201114132914/https://www.reuters.com/article/biontech-fosunpharma-vaccine-collaborati/biontech-in-china-alliance-with-fosun-over-coronavirus-vaccine-candidate-idUSL8N2B90UW . live.
  153. News: 9 April 2020. Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development. Reuters. 21 March 2021. 11 May 2021. https://web.archive.org/web/20210511164633/https://www.reuters.com/article/brief-pfizer-and-biontech-announce-furth-idINL5N2BX46N. live.
  154. Pfizer and BioNTech announce further details on collaboration to accelerate global COVID-19 vaccine development. Pfizer. 9 April 2020. 19 April 2021. 19 April 2021. https://web.archive.org/web/20210419052628/https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-further-details-collaboration. live.
  155. Web site: 11 June 2020. Germany: Investment Plan for Europe – EIB to provide BioNTech with up to €100million in debt financing for COVID-19 vaccine development and manufacturing. https://web.archive.org/web/20201109174611/https://www.eib.org/en/press/all/2020-144-eib-to-provide-biontech-with-up-to-eur-100-million-in-debt-financing-for-covid-19-vaccine-development-and-manufacturing. 9 November 2020. 10 November 2020. European Investment Bank . live .
  156. Web site: BioNTech moves to head of pack for COVID-19 vaccine with EU finance. 30 June 2021. European Investment Bank . Knight C . 17 November 2020 . 1 May 2021. https://web.archive.org/web/20210501142843/https://www.eib.org/en/stories/eu-financing-for-covid-19-vaccine. live.
  157. News: BioNTech gets $445 million in German funding for vaccine . Kresge N . 10 November 2020 . Bloomberg L.P. . 15 September 2020 . 9 November 2020 . https://web.archive.org/web/20201109130431/https://www.bloomberg.com/news/articles/2020-09-15/biontech-gets-445-million-in-german-funding-for-covid-vaccine . live .
  158. News: 9 November 2020. Pfizer CEO says he would've released vaccine data before election if possible. 11 November 2020. Axios. 10 November 2020. https://web.archive.org/web/20201110214718/https://www.axios.com/pfizer-ceo-says-he-wouldve-released-vaccine-data-before-election-if-possible-a4f0c822-bf49-4a04-ac7f-5275c8d895b4.html. live.
  159. Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Raabe V, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Walsh EE, Frenck R, Falsey AR, Dormitzer PR, Gruber WC, Şahin U, Jansen KU . Phase I–II study of COVID-19 RNA vaccine BNT162b1 in adults . Nature . 586 . 7830 . 589–593 . October 2020 . 32785213 . 10.1038/s41586-020-2639-4 . 2020Natur.586..589M . 221126922 . free . doi .
  160. News: China's Fosun to end BioNTech's COVID-19 vaccine trial, seek approval for another. Reuters. 3 November 2020. 21 November 2020. 12 December 2020. https://web.archive.org/web/20201212204750/https://www.reuters.com/article/health-coronavirus-fosunpharma-idINL4N2HQ1UU?edition-redirect=ca. live.
  161. News: Herper M . Pfizer and BioNTech's favored Covid-19 vaccine has fewer side effects than their first . 11 June 2021 . Stat News. 20 August 2020 . 11 June 2021 . https://web.archive.org/web/20210611225800/https://www.statnews.com/2020/08/20/pfizer-biontech-favored-covid19-vaccine-has-fewer-side-effects-than-first-one/ . live .
  162. News: Hannah B . 7 October 2020 . EMA begins rolling review of BNT162b2 COVID-19 vaccine . European Pharmaceutical Review . 11 November 2020 . 11 November 2020 . https://web.archive.org/web/20201111123200/https://www.europeanpharmaceuticalreview.com/news/129817/ema-begins-rolling-review-of-bnt162b2-covid-19-vaccine/ . live .
  163. European public assessment report . Committee for Medicinal Products for Human Use . Assessment report: Comirnaty . EMA/707383/2020 . Corr.1 . COVID-19 Case Definitions; tables 2, 7, 8 and 10; All Confirmed Cases of COVID-19 After Dose 1; Favourable effects . European Medicines Agency (EMA) . 19 February 2021 . 23 June 2021 . PDF . 20 June 2021 . https://web.archive.org/web/20210620120447/https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf . live .
  164. News: Clarification of Comirnaty dosage interval . European Medicines Agency (EMA) . 28 January 2021 . 28 January 2021 . 17 February 2021 . https://web.archive.org/web/20210217054713/https://www.ema.europa.eu/en/news/clarification-comirnaty-dosage-interval . live .
  165. News: Edwards E. 9 November 2020. Pfizer's Covid-19 vaccine promising, but many questions remain. NBC News. 12 November 2020. 22 November 2020. https://web.archive.org/web/20201122161113/https://www.nbcnews.com/health/health-news/pfizer-s-covid-19-vaccine-promising-many-questions-remain-n1247102. live.
  166. News: 9 November 2020. Covid vaccine: First 'milestone' vaccine offers 90% protection. BBC News. 9 November 2020. https://web.archive.org/web/20201126013146/https://www.bbc.com/news/health-54873105. 26 November 2020. Gallagher J . live .
  167. Favresse J, Bayart J, Mullier F, Elsen M, Eucher C, Eeckhoudt S, Roy T, Wieers G, Laurent C, Dogné J, Closset M . 7 July 2021 . Antibody titers decline 3-month post-vaccination with BNT162b2 . Emerging Microbes & Infections . 10 . 1 . 1495–1498 . 10.1080/22221751.2021.1953403 . 34232116 . 8300930 . 235757143 . free . doi .
  168. Gray KJ, Bordt EA, Atyeo C, Deriso E, Akinwunmi B, Young N, Baez AM, Shook LL, Cvrk D, James K, De Guzman R, Brigida S, Diouf K, Goldfarb I, Bebell LM, Yonker LM, Fasano A, Rabi SA, Elovitz MA, Alter G, Edlow AG . Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study . American Journal of Obstetrics & Gynecology . 225. 3. 303.e1–303.e17. March 2021 . 33775692 . 7997025 . 10.1016/j.ajog.2021.03.023 . free . doi .
  169. News: Pfizer says its Covid vaccine trial for kids ages 12 to 15 is fully enrolled . 22 January 2021 . CNBC . Tirrell M, Wells N . 11 May 2021 . 16 May 2021 . https://web.archive.org/web/20210516134016/https://www.cnbc.com/2021/01/22/pfizer-says-its-covid-vaccine-trial-for-kids-ages-12-to-15-is-fully-enrolled.html . live .
  170. Web site: BioNTech-Pfizer say COVID-19 vaccine 100% effective on 12- to 15-year-olds . CNA . 31 March 2021 . 31 March 2021 . 31 March 2021 . https://web.archive.org/web/20210331125001/https://www.channelnewsasia.com/news/world/covid-19-biontech-pfizer-vaccine-100-effective-adolescents-14531556 . live .
  171. Boyarsky BJ, Werbel WA, Avery RK, Tobian AA, Massie AB, Segev DL, Garonzik-Wang JM . Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients . JAMA . 325 . 17 . 1784–86 . May 2021 . 33720292 . 10.1001/jama.2021.4385 . 7961463 . free . doi .
  172. Thacker PD . Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial . BMJ . 375 . n2635 . November 2021 . 34728500 . 10.1136/bmj.n2635 . 240424253 . A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported. free .
  173. Web site: Gorski D . What the heck happened to The BMJ? . 8 November 2021 . . 8 November 2021 . 8 November 2021 . https://web.archive.org/web/20211108130323/https://sciencebasedmedicine.org/what-the-heck-happened-to-the-bmj/ . live .
  174. Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine . . 21 October 2021 . 23 October 2021 . 22 October 2021 . https://web.archive.org/web/20211022235037/https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-phase-3-trial-data-showing . live .
  175. News: Britain OKs Pfizer vaccine and will begin shots within days . Associated Press . 2 December 2020 . Neergaard L, Kirka D . 6 December 2020 . 6 December 2020 . https://web.archive.org/web/20201206161358/https://apnews.com/article/uk-authorizes-vaccine-emergency-use-ea0170c978eb281a905866e5bd78bbdf . live .
  176. News: Mueller B . U.K. Approves Pfizer Coronavirus Vaccine, a First in the West . 2 December 2020 . The New York Times . 2 December 2020 . 28 January 2021 . https://web.archive.org/web/20210128124416/https://www.nytimes.com/2020/12/02/world/europe/pfizer-coronavirus-vaccine-approved-uk.html . live .
  177. News: 2 December 2020 . Covid Pfizer vaccine approved for use next week in UK . Roberts M . . 2 December 2020 . 2 December 2020 . https://web.archive.org/web/20201202070718/https://www.bbc.com/news/health-55145696 . live .
  178. News: European and US experts question UK's fast-track of Covid vaccine. 3 December 2020. Henley J, Connolly, Jones S . The Guardian. 9 December 2020. 9 December 2020. https://web.archive.org/web/20201209004141/https://www.theguardian.com/world/2020/dec/03/europe-us-experts-question-uk-fast-track-covid-vaccine. live .
  179. News: Coronavirus en la Argentina: La ANMAT aprobo el uso de emergencia de la vacuna Pfizer. 25 December 2020. La Nación. Costa JM . es. 26 January 2021. https://web.archive.org/web/20210126205219/https://www.lanacion.com.ar/sociedad/coronavirus-argentina-anmat-aprobo-uso-emergencia-vacuna-nid2548852. live.
  180. TGA provisionally approves Pfizer COVID-19 vaccine . . 25 January 2021 . 26 January 2021 . 26 January 2021 . https://web.archive.org/web/20210126071449/https://www.tga.gov.au/media-release/tga-provisionally-approves-pfizer-covid-19-vaccine . live .
  181. Web site: Bahrain becomes second country to approve Pfizer COVID-l19 vaccine . . 4 December 2020 . 4 December 2020 . https://web.archive.org/web/20201204211007/https://www.aljazeera.com/news/2020/12/4/bahrain-becomes-second-country-to-approve-pfizer-covid-19-vaccine . live .
  182. Web site: Pfizer–BioNTech COVID-19 Vaccine (tozinameran) . 9 December 2020 . . 15 December 2020 . 16 December 2020 . https://web.archive.org/web/20201216003438/https://covid-vaccine.canada.ca/pfizer-biontech-covid-19-vaccine/product-details . live .
  183. Web site: 9 December 2020. Drug and vaccine authorizations for COVID-19: List of applications received. 9 December 2020. Health Canada. 18 March 2021. https://web.archive.org/web/20210318002401/https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/authorization/applications.html. live.
  184. Web site: Chile y Ecuador se adelantan en Sudamérica y autorizan la vacuna de Pfizer . 16 December 2020 . El Pais . Montes R, España S . 17 December 2020 . 16 December 2020 . https://web.archive.org/web/20201216222640/https://elpais.com/sociedad/2020-12-16/chile-y-ecuador-se-adelantan-en-sudamerica-y-autorizan-la-vacuna-de-pfizer.html . live .
  185. News: 23 December 2020. First Pfizer COVID-19 vaccines set to reach Costa Rica on Wednesday – president. Reuters. 24 December 2020. 9 March 2021. https://web.archive.org/web/20210309150520/https://www.reuters.com/article/health-coronavirus-costarica-vaccine-idUSS0N2HB06S. live.
  186. SFH authorises COVID-19 vaccine by Fosun Pharma/BioNTech for emergency use in Hong Kong . . 25 January 2021 . 26 January 2021 . 19 March 2021 . https://web.archive.org/web/20210319090956/https://www.info.gov.hk/gia/general/202101/25/P2021012500829.htm . live .
  187. Web site: Iraq grants emergency approval for Pfizer COVID-19 vaccine. 27 December 2020. 27 December 2020. MSN. 8 January 2021. https://web.archive.org/web/20210108101400/https://www.msn.com/en-ae/news/other/iraq-grants-emergency-approval-for-pfizer-covid-19-vaccine/ar-BB1cgvD6. live.
  188. Web site: Israeli Health Minister 'pleased' as FDA approves Pfizer COVID-19 vaccine. Jaffe-Hoffman M . 12 December 2020 . 28 December 2020. The Jerusalem Post. 19 March 2021. https://web.archive.org/web/20210319104432/https://www.jpost.com/breaking-news/fda-approves-pfizer-biontech-covid-19-vaccine-for-emergency-use-nyt-651871. live.
  189. Web site: 15 December 2020. Jordan approves Pfizer–BioNTech Covid vaccine. 15 December 2020. France 24. 9 March 2021. https://web.archive.org/web/20210309150527/https://www.france24.com/en/live-news/20201215-jordan-approves-pfizer-biontech-covid-vaccine. live.
  190. Web site: 15 December 2020. Kuwait authorizes emergency use of Pfizer–BioNTech COVID-19 vaccine. 13 December 2020. Arab News. 19 March 2021. https://web.archive.org/web/20210319120421/https://www.arabnews.com/node/1776666/middle-east. live.
  191. Web site: Malaysia's NPRA Approves Pfizer Covid-19 Vaccine. CodeBlue. 8 January 2021. 25 February 2021. 20 January 2021. https://web.archive.org/web/20210120091910/https://codeblue.galencentre.org/2021/01/08/malaysias-npra-approves-pfizer-covid-19-vaccine/. live.
  192. News: Solomon DB, Torres N . Mexico approves emergency use of Pfizer's COVID-19 vaccine . . 11 December 2020 . 14 December 2020 . 15 January 2021 . https://web.archive.org/web/20210115173149/https://www.reuters.com/article/us-health-coronavirus-mexico-idUSKBN28M019 . live .
  193. News: 12 December 2020. Mexico Approves Pfizer Vaccine for Emergency Use as Covid Surges. Bloomberg. Quinn D . 12 December 2020. 8 January 2021. https://web.archive.org/web/20210108043302/https://www.bloomberg.com/news/articles/2020-12-12/mexico-approves-pfizer-vaccine-for-emergency-use-as-covid-surges. live.
  194. News: 15 December 2020. Oman issues licence to import Pfizer BioNTech Covid vaccine – TV. Reuters. 16 December 2020. 9 March 2021. https://web.archive.org/web/20210309150457/https://www.reuters.com/article/health-coronavirus-oman-vaccine-int-idUSKBN28P1RA. live.
  195. News: Panama approves Pfizer's COVID-19 vaccine – health ministry . Moreno E . . 15 December 2020 . 8 May 2021 . 8 February 2021 . https://web.archive.org/web/20210208234438/https://www.reuters.com/article/health-coronavirus-panama/panama-approves-pfizers-covid-19-vaccine-health-ministry-idUSS0N2HB06H . live .
  196. News: 14 January 2021. PH authorizes Pfizer's COVID-19 vaccine for emergency use. CNN Philippines. 21 January 2021. 27 February 2021. https://web.archive.org/web/20210227101930/https://cnnphilippines.com/news/2021/1/14/Pfizer-COVID-19-vaccine-Philippines-FDA-emergency-use-EUA.html. dead.
  197. News: 24 December 2020. Qatar, Oman to receive Pfizer–BioNTech COVID-19 vaccine this week. 21 December 2020. Reuters. 9 March 2021. https://web.archive.org/web/20210309150503/https://www.reuters.com/article/us-health-coronavirus-vaccine-qatar/qatar-oman-to-receive-pfizer-biontech-covid-19-vaccine-this-week-idUSKBN28U0VE. live.
  198. News: 10 December 2020. Coronavirus: Saudi Arabia approves Pfizer COVID-19 vaccine for use. 10 December 2020. Al Arabiya English. Krimly R . 11 December 2020. https://web.archive.org/web/20201211155342/https://english.alarabiya.net/en/coronavirus/2020/12/10/Coronavirus-Saudi-Arabia-approves-Pfizer-COVID-19-vaccine-for-use. live.
  199. News: Al Mulla Y . Kuwait approves emergency use of Pfizer vaccine . . 13 December 2020 . 14 December 2020 . 14 December 2020 . https://web.archive.org/web/20201214125031/https://gulfnews.com/world/gulf/kuwait/kuwait-approves-emergency-use-of-pfizer-vaccine-1.75875294 . live .
  200. News: Saudi Arabia to Launch Its Coronavirus Vaccination Program . 15 December 2020 . Bloomberg . Khraiche D . 17 December 2020 .
  201. News: First shipments of Pfizer–BioNTech vaccine in Singapore by end-Dec; enough vaccines for all by Q3 2021. 14 December 2020. The Straits Times. 14 December 2020. 14 December 2020. https://web.archive.org/web/20201214091234/https://www.straitstimes.com/singapore/health/first-shipments-of-pfizer-biontech-vaccine-in-singapore-by-end-dec-enough-vaccines. Tan A . live .
  202. Web site: Abdullah Z . Pfizer–BioNTech COVID-19 vaccine approved by Singapore, first shipment expected by end-December . CNA . 16 January 2021 . 14 December 2020 . 4 February 2021 . https://web.archive.org/web/20210204082015/https://www.channelnewsasia.com/news/singapore/singapore-approves-pfizer-biontech-covid-19-vaccine-phase-3-13769570 . live .
  203. Web site: 15 December 2020. Singapore approves use of Pfizer's COVID-19 vaccine. 14 December 2020. AP News. 22 January 2021. https://web.archive.org/web/20210122101951/https://apnews.com/article/science-singapore-coronavirus-pandemic-lee-hsien-loong-coronavirus-vaccine-5bf8461b9d2d32ec08d56fcf5958317a. live.
  204. News: Lim JY . 3 February 2021. South Korea approves special import of Pfizer vaccine. 28 February 2021. The Korea Herald . 16 February 2021. https://web.archive.org/web/20210216020623/http://www.koreaherald.com/view.php?ud=20210203001122. live.
  205. News: Lee K . 27 February 2021. S. Korea begins rolling out Pfizer vaccines on second day of national vaccination program. 28 February 2021. Arirang News . 10 March 2021. https://web.archive.org/web/20210310013846/https://www.arirang.com/news/News_View.asp?nseq=273056. live.
  206. Web site: 23 December 2020. Dubai approves the Pfizer–BioNTech vaccine which will be free of charge. Morris O . 28 December 2020. Emirates Woman. 31 January 2021. https://web.archive.org/web/20210131135503/https://emirateswoman.com/dubai-approves-the-pfizer-biontech-vaccine-for-free/. live.
  207. FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine . U.S. Food and Drug Administration (FDA) . 11 December 2020 . 11 December 2020 . 18 March 2021 . https://web.archive.org/web/20210318070621/https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19 . live .
  208. Web site: Vietnam approves Pfizer Covid vaccine for emergency use. Nga L . VnExpress. 12 June 2021. 15 June 2021. https://web.archive.org/web/20210615091636/https://e.vnexpress.net/news/news/vietnam-approves-pfizer-covid-vaccine-for-emergency-use-4293267.html. 15 June 2021. live.
  209. WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access . World Health Organization (WHO) . 31 December 2020 . 6 January 2021 . 17 March 2021 . https://web.archive.org/web/20210317043909/https://www.who.int/news/item/31-12-2020-who-issues-its-first-emergency-use-validation-for-a-covid-19-vaccine-and-emphasizes-need-for-equitable-global-access . live .
  210. Web site: WHO recommendation BioNtech Tozinameran – COVID-19 mRNA vaccine (nucleoside modified) – Comirnaty . World Health Organization (WHO) . 31 December 2020 . 30 May 2021 . 9 May 2021 . https://web.archive.org/web/20210509155424/https://extranet.who.int/pqweb/vaccines/who-recommendation-covid-19-mrna-vaccine-nucleoside-modified-comirnaty . live .
  211. The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know . World Health Organization (WHO) . 18 August 2022 . 2 September 2022.
  212. Web site: Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency Use Listing . World Health Organization (WHO) . 18 August 2022 . 2 September 2022.
  213. Web site: Emergency Use Authorization for vaccines explained . U.S. Food and Drug Administration (FDA) . 20 November 2020 . 20 November 2020 . 20 November 2020 . https://web.archive.org/web/20201120184730/https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained . live .
  214. News: Pfizer has applied for emergency use for its Covid-19 vaccine . Edwards E . . 20 November 2020 . 13 April 2021 . 18 March 2021 . https://web.archive.org/web/20210318061603/https://www.nbcnews.com/health/health-news/pfizer-apply-emergency-use-its-covid-19-vaccine-n1248319 . live .
  215. News: Sun LH, Stanley-Becker I. CDC greenlights advisory group's decision to recommend Pfizer vaccine for use. 12 December 2020. The Washington Post. 14 December 2020. 13 December 2020. https://web.archive.org/web/20201213195353/https://www.washingtonpost.com/health/2020/12/12/covid-vaccine-cdc-approval/. live.
  216. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer–BioNTech COVID-19 Vaccine – United States, December 2020 . Oliver SE, Gargano JW, Marin M, Wallace M, Curran KG, Chamberland M, McClung N, Campos-Outcalt D, Morgan RL, Mbaeyi S, Romero JR, Talbot HK, Lee GM, Bell BP, Dooling K . MMWR. Morbidity and Mortality Weekly Report . 18 December 2020 . 69 . 50 . 1922–24 . 33332292 . 10.15585/mmwr.mm6950e2 . 7745957 . free . 16 December 2020 . 19 December 2020 . https://web.archive.org/web/20201219193006/https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6950e2-H.pdf . live .
  217. Web site: Pfizer–BioNTech COVID-19 Vaccine EUA Letter of Authorization . U.S. Food and Drug Administration (FDA) . 12 August 2021 . PDF . 13 August 2021 . 14 August 2021 . https://web.archive.org/web/20210814041706/https://www.fda.gov/media/150386/download . live .
  218. Web site: Pfizer–BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers . Pfizer . PDF . 12 August 2021 . 13 August 2021 . 14 August 2021 . https://web.archive.org/web/20210814042307/https://www.fda.gov/media/144413/download . live .
  219. Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic . U.S. Food and Drug Administration (FDA) . 10 May 2021 . 11 May 2021 . 10 May 2021 . https://web.archive.org/web/20210510235407/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use . live .
  220. News: Saltzman J, Weisman R . FDA authorizes Pfizer COVID-19 vaccine for adolescents 12 to 15 years old . The Boston Globe . 10 May 2021 . 11 May 2021 . 11 May 2021 . https://web.archive.org/web/20210511005434/https://www.bostonglobe.com/2021/05/10/business/pfizer-vaccine-cleared-children-age-12-15/ . live .
  221. CDC Director Statement on Pfizer's Use of COVID-19 Vaccine in Adolescents Age 12 and Older . U.S. Centers for Disease Control and Prevention (CDC) . 12 May 2021 . 12 May 2021 . 17 May 2021 . https://web.archive.org/web/20210517155513/https://www.cdc.gov/media/releases/2021/s0512-advisory-committee-signing.html . live .
  222. Web site: COVID-19 Vaccines for Children and Teens . U.S. Centers for Disease Control and Prevention (CDC) . 12 May 2021 . 12 May 2021 . 18 May 2021 . https://web.archive.org/web/20210518211835/https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/adolescents.html . live .
  223. FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age . U.S. Food and Drug Administration (FDA) . 29 October 2021 . 4 November 2021 . 3 November 2021 . https://web.archive.org/web/20211103234033/https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age . live .
  224. Web site: Karrim A . Covid-19: Sahpra approves Section 21 use of Pfizer vaccine. 16 March 2021 . 18 March 2021. News24 . 18 March 2021. https://web.archive.org/web/20210318172253/https://www.news24.com/news24/southafrica/news/covid-19-sahpra-approves-section-21-use-of-pfizer-vaccine-20210316. live.
  225. Web site: South Africa approves Pfizer Covid-19 vaccine for emergency use . BusinessTech . 16 March 2021. 18 March 2021 . 18 March 2021. https://web.archive.org/web/20210318184922/https://businesstech.co.za/news/trending/476360/south-africa-approves-pfizer-covid-19-vaccine-for-emergency-use/. live.
  226. Web site: Regulatory Decision Summary - Pfizer-BioNTech COVID-19 Vaccine . . 5 May 2021 . 11 May 2021 . 12 May 2021 . https://web.archive.org/web/20210512081946/https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detailTwo.html?linkID=RDS00802 . live .
  227. Web site: Aiello R . 5 May 2021. Children 12 and older now cleared to receive Pfizer vaccine: Health Canada. 7 May 2021. CTV News. 6 May 2021. https://web.archive.org/web/20210506231959/https://www.ctvnews.ca/health/coronavirus/children-12-and-older-now-cleared-to-receive-pfizer-vaccine-health-canada-1.5414935. live.
  228. News: Ang HM . Children aged 12 to 15 years to receive Pfizer-BioNTech COVID-19 vaccine in Singapore. CNA. 18 May 2021. 18 May 2021. 18 May 2021. https://web.archive.org/web/20210518101132/https://www.channelnewsasia.com/news/singapore/covid-19-pfizer-biontech-vaccine-children-singapore-12-15-14833074. live.
  229. Web site: EU regulator backs Pfizer-BioNTech COVID-19 vaccine for children aged 12 to 15 . CNA . 31 May 2021 . 28 May 2021 . 2 June 2021 . https://web.archive.org/web/20210602213347/https://www.channelnewsasia.com/news/world/eu-regulator-backs-pfizer-biontech-covid-19-vaccine-for-children-14906200 . dead .
  230. Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland . . 18 December 2020 . 5 July 2022 . 2 May 2021 . https://web.archive.org/web/20210502135025/https://www.swissmedic.ch/swissmedic/en/home/news/coronavirus-covid-19/covid-19-impfstoff_erstzulassung.html . live .
  231. Pfizer/BioNTech COVID-19 vaccine approved for young people in Switzerland . . 7 May 2021 . 5 July 2022 . 4 June 2022 . https://web.archive.org/web/20220604032012/https://www.swissmedic.ch/swissmedic/en/home/news/coronavirus-covid-19/covid-19-impfstoff-pfizer-biontech-fuer-jugendliche.html . live .
  232. Swissmedic approves COVID-19 vaccine from Pfizer/BioNTech for children aged 5 to 11 years . . 7 December 2021 . 5 July 2022 . 15 June 2022 . https://web.archive.org/web/20220615052831/https://www.swissmedic.ch/swissmedic/en/home/news/coronavirus-covid-19/covid-19-impfstoff-pfizer-biontec-kinder-5-11-jahren-genehmigt.html . live .
  233. COVID-19 vaccines from Moderna and Pfizer/BioNTech: Swissmedic approves third vaccination for certain population groups . . 26 October 2021 . 5 July 2022 . 30 May 2022 . https://web.archive.org/web/20220530094630/https://www.swissmedic.ch/swissmedic/en/home/news/coronavirus-covid-19/genehmigung-booster-impfung.html . live .
  234. COVID-19 vaccine from Pfizer/BioNTech: Swissmedic approves the extension of the booster dose to everyone aged 16 years and over . . 26 October 2021 . 5 July 2022 . 4 April 2022 . https://web.archive.org/web/20220404072555/https://www.swissmedic.ch/swissmedic/en/home/news/coronavirus-covid-19/covid-19-impfstoff-pfizer-biontech-boosterdosis.html . live .
  235. COVID-19: Switzerland can start vaccinating vulnerable groups already in December . Federal Office of Public Health . 19 December 2020 . 19 December 2020 . 9 January 2021 . https://web.archive.org/web/20210109145748/https://www.bag.admin.ch/bag/en/home/das-bag/aktuell/medienmitteilungen.msg-id-81762.html . live .
  236. EMA recommends first COVID-19 vaccine for authorisation in the EU . European Medicines Agency (EMA) . 21 December 2020 . 21 December 2020 . 30 January 2021 . https://web.archive.org/web/20210130114031/https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorisation-eu . live .
  237. Web site: Comirnaty . Union Register of medicinal products . European Commission . 8 January 2021 . 24 January 2021 . https://web.archive.org/web/20210124174708/https://ec.europa.eu/health/documents/community-register/html/h1528.htm . live .
  238. Web site: Statement by President von der Leyen on the marketing authorisation of the BioNTech-Pfizer vaccine against COVID-19 . . 21 December 2020 . 21 December 2020 . 11 January 2021 . https://web.archive.org/web/20210111180445/https://ec.europa.eu/commission/presscorner/detail/en/STATEMENT_20_2510 . live .
  239. News: Brazil approves Pfizer's COVID-19 shot, but has none to use . Reuters . 23 February 2021 . 18 July 2021 . 25 February 2021 . https://web.archive.org/web/20210225093644/https://www.reuters.com/article/us-health-coronavirus-brazil-idUSKBN2AN19Q . live .
  240. News: Anvisa aprova registro da vacina da Pfizer contra Covid . Cancian N . 23 February 2021 . 23 February 2021 . Portuguese . . 23 February 2021 . https://web.archive.org/web/20210223124706/https://www1.folha.uol.com.br/equilibrioesaude/2021/02/anvisa-aprova-registro-da-vacina-da-pfizer-contra-covid.shtml . live .
  241. ANVISA aprova vacina da Pfizer contra a COVID-19 . Pfizer Brasil . pt . 18 July 2021 . 18 July 2021 . https://web.archive.org/web/20210718201317/https://www.pfizer.com.br/anvisa-aprova-vacina-da-pfizer-contra-covid-19 . live .
  242. Web site: Informe à população brasileira . Agência Nacional de Vigilância Sanitária - Anvisa . 23 February 2021 . pt . 18 July 2021 . 18 July 2021 . https://web.archive.org/web/20210718201316/https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/informe-a-populacao-brasileira . live .
  243. News: Brazil approves Pfizer COVID-19 vaccine for children over 12 . Reuters . 11 June 2021 . 18 July 2021 . 18 July 2021 . https://web.archive.org/web/20210718201314/https://www.reuters.com/business/healthcare-pharmaceuticals/brazil-approves-pfizer-covid-19-vaccine-children-over-12-2021-06-11/ . live .
  244. Web site: Anvisa autoriza vacina da Pfizer para crianças com mais de 12 anos . Agência Nacional de Vigilância Sanitária - Anvisa . 11 June 2021 . pt . 18 July 2021 . 23 June 2021 . https://web.archive.org/web/20210623220705/https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/anvisa-autoriza-vacina-da-pfizer-para-criancas-com-mais-de-12-anos . live .
  245. Web site: Report: How Pfizer Silences World Governments in Vaccine Negotiations . 24 June 2022 . Public Citizen . 19 October 2021 . 24 June 2022 . https://web.archive.org/web/20220624173042/https://www.citizen.org/news/report-how-pfizer-silences-world-governments-in-vaccine-negotiations/ . live .
  246. Web site: 'Held to ransom': Pfizer demands governments gamble with state assets to secure vaccine deal . 24 June 2022 . The Bureau of Investigative Journalism . 23 February 2021 . Davies M, Furneaux R, Ruiz I, Langlois J . 24 June 2022 . https://web.archive.org/web/20220624032205/https://www.thebureauinvestigates.com/stories/2021-02-23/held-to-ransom-pfizer-demands-governments-gamble-with-state-assets-to-secure-vaccine-deal . live .
  247. U.S. FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 Vaccine . BioNTech . 16 July 2021 . 18 July 2021 . 18 July 2021 . https://web.archive.org/web/20210718193750/https://investors.biontech.de/news-releases/news-release-details/us-fda-grants-priority-review-biologics-license-application . live .
  248. News: U.S. FDA sets January target to decide on approval of Pfizer's COVID-19 shot. 16 July 2021. Reuters. 16 July 2021. 16 July 2021. https://web.archive.org/web/20210716163557/https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-decide-pfizer-covid-19-vaccine-approval-by-january-2022-2021-07-16/. live.
  249. FDA Approves First COVID-19 Vaccine . 23 August 2021 . U.S. Food and Drug Administration (FDA) . 23 August 2021 . https://web.archive.org/web/20210823143040/https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine . 23 August 2021 . live.
  250. News: Howard J . 23 August 2021 . FDA grants full approval to Pfizer/BioNTech Covid-19 vaccine, opening door to more vaccine mandates . CNN . 23 August 2021 . 23 August 2021 . https://web.archive.org/web/20210823130516/https://www.cnn.com/2021/08/23/health/fda-approval-pfizer-covid-vaccine/index.html . live .
  251. Web site: Pfizer-BioNTech Comirnaty COVID-19 vaccine . 9 December 2020 . . 18 September 2021 . 5 June 2021 . https://web.archive.org/web/20210605080328/https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/pfizer-biontech.html . live .
  252. Web site: Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications . . 17 September 2020 . 17 September 2021 . 24 March 2021 . https://web.archive.org/web/20210324230529/https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/authorization/list-drugs.html . live .
  253. Web site: Regulatory Decision Summary - Comirnaty . . 15 September 2021 . 18 September 2021 . 19 September 2021 . https://web.archive.org/web/20210919064716/https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detail.html?linkID=RDS00856 . live .
  254. Web site: Pfizer, Moderna vaccines granted full approval by Health Canada; get unique name change . https://web.archive.org/web/20211009024015/https://www.citynews1130.com/2021/09/16/health-canada-pfizer-moderna-astrazeneca-name-change/ . 16 September 2021 . Casaletto L . 9 October 2021. 17 September 2021. CityNews . live .
  255. FDA Roundup: July 8, 2022 . U.S. Food and Drug Administration (FDA) . 8 July 2022 . 9 July 2022.
  256. EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines . European Medicines Agency (EMA) . 16 September 2022 . 18 September 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  257. Web site: Tal A . 30 July 2021 . Israel to offer third Covid-19 vaccine dose to people over 60 . https://web.archive.org/web/20211203210058/http://edition.cnn.com/2021/07/30/middleeast/israel-covid-booster-shot-intl/index.html. 3 December 2021 . 3 September 2021 . . live .
  258. Web site: Lieber D . 31 August 2021 . In Israel, Being Fully Vaccinated Now Means Three Shots - Israeli study finds booster shot of Pfizer vaccine can give 10-fold protection against severe illness . https://web.archive.org/web/20211130070224/https://www.wsj.com/articles/in-israel-being-fully-vaccinated-now-means-three-shots-11630426257. 30 November 2021 . subscription . 3 September 2021 . . live .
  259. Bar-On YM, Goldberg Y, Mandel M, Bodenheimer O, Freedman L, Kalkstein N, Mizrahi B, Alroy-Preis S, Ash N, Milo R, Huppert A . Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel . The New England Journal of Medicine . October 2021 . 34525275 . 10.1056/nejmoa2114255 . free . Table 2 . 8461568 . doi . 385 . 15 .
  260. 18 August 2021 . Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots . https://web.archive.org/web/20211207200939/https://www.hhs.gov/about/news/2021/08/18/joint-statement-hhs-public-health-and-medical-experts-covid-19-booster-shots.html. 7 December 2021 . United States Department of Health and Human Services . 21 August 2021 . live .
  261. Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals . U.S. Food and Drug Administration (FDA) . 12 August 2021 . https://web.archive.org/web/20211207181329/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised . 7 December 2021 . 13 August 2021 . live .
  262. Web site: COVID-19 Vaccines for Moderately or Severely Immunocompromised People . U.S. Centers for Disease Control and Prevention (CDC) . 13 August 2021 . https://web.archive.org/web/20211210092203/https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html. 10 December 2021 . 13 August 2021 . live .
  263. August 2021 . The WHO is right to call a temporary halt to COVID vaccine boosters . Nature . 596 . 7872 . 317 . 10.1038/d41586-021-02219-w . 34404945 . 2021Natur.596..317. . 237199262 . Editorial . free . doi .
  264. 10 August 2021 . Interim statement on COVID-19 vaccine booster doses . https://web.archive.org/web/20211127012658/https://www.who.int/news/item/10-08-2021-interim-statement-on-covid-19-vaccine-booster-doses. 27 November 2021 . World Health Organization (WHO) . 26 August 2021 . live .
  265. News: Kramer J . The U.S. plans to authorize boosters—but many already got a third dose . https://web.archive.org/web/20211010113551/https://www.nationalgeographic.com/science/article/the-us-is-expected-to-authorize-boostersbut-many-already-got-a-third-dose . 10 October 2021 . 21 August 2021 . National Geographic . 18 August 2021 . Getting a booster too soon after primary inoculation might not teach the body's immune system to mount a more robust defense . dead .
  266. FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations . U.S. Food and Drug Administration (FDA) . 22 September 2021 . https://web.archive.org/web/20211208015251/https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations . 8 December 2021 . 23 September 2021 . live .
  267. Web site: Advisory committee recommends wide swath of Americans be offered Covid-19 vaccine boosters . . 23 September 2021 . Branswell H . https://web.archive.org/web/20211116180025/https://www.statnews.com/2021/09/23/covid19-vaccine-boosters-cdc-acip/ . 16 November 2021 . 23 September 2021 . live .
  268. News: C.D.C. Chief Overrules Agency Panel and Recommends Pfizer-BioNTech Boosters for Workers at Risk . The New York Times . Original date 24 September 2021 . 21 October 2021 . Mandavilli A, Mueller B . https://web.archive.org/web/20210924062127/https://www.nytimes.com/2021/09/24/world/covid-boosters-vaccine-cdc-director.html. 24 September 2021 . 24 September 2021 . live .
  269. Web site: Comirnaty and Spikevax: EMA recommendations on extra doses and boosters . European Medicines Agency (EMA) . 4 October 2021 . https://web.archive.org/web/20211211104957/https://www.ema.europa.eu/en/news/comirnaty-spikevax-ema-recommendations-extra-doses-boosters . 11 December 2021 . 4 October 2021 . live .
  270. Web site: Pronczuk M . 4 October 2021 . The European Medicines Agency said that a booster shot of the Pfizer-BioNTech vaccine can be given to healthy adults . https://web.archive.org/web/20211004173702/https://www.nytimes.com/2021/10/04/world/europe/pfizer-booster-ema.html. 4 October 2021 . 4 October 2021 . . live .
  271. Web site: Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines . U.S. Food and Drug Administration (FDA) . 21 October 2021 . https://web.archive.org/web/20211207201028/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-additional-actions-use-booster-dose-covid-19-vaccines . 7 December 2021 . 22 October 2021 . live .
  272. CDC Expands Eligibility for COVID-19 Booster Shots . U.S. Centers for Disease Control and Prevention (CDC) . 21 October 2021 . https://web.archive.org/web/20211207000758/https://www.cdc.gov/media/releases/2021/p1021-covid-booster.html . 7 December 2021 . 22 October 2021 . live .
  273. Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters . U.S. Food and Drug Administration (FDA) . 19 November 2021 . 19 November 2021 . 19 November 2021 . https://web.archive.org/web/20211119144009/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-covid-19-vaccine-boosters . live .
  274. Web site: TGA approves booster doses of the Pfizer COVID-19 vaccine, Comirnaty . Therapeutic Goods Administration (TGA) . 27 October 2021 . 14 November 2021 . 14 November 2021 . https://web.archive.org/web/20211114232058/https://www.tga.gov.au/tga-approves-booster-doses-pfizer-covid-19-vaccine-comirnaty . live .
  275. Web site: COVID-19 vaccine: Pfizer Australia - Comirnaty BNT162b2 (mRNA) . Therapeutic Goods Administration (TGA) . 2 November 2021 . 14 November 2021 . 9 June 2021 . https://web.archive.org/web/20210609120309/https://www.tga.gov.au/covid-19-vaccine-pfizer-australia-comirnaty-bnt162b2-mrna . live .
  276. Web site: Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine . U.S. Food and Drug Administration . 3 January 2022 . 3 January 2022 . 3 January 2022 . https://web.archive.org/web/20220103144625/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-multiple-actions-expand-use-pfizer-biontech-covid-19-vaccine . live .
  277. Web site: Fact Sheet for Healthcare Providers Administering Vaccine - Pfizer-BioNTech COVID-19 Vaccine for 5 - 11 Years of Age . Food and Drug Administration. https://web.archive.org/web/20220121131918/https://www.fda.gov/media/153714/download . 3 January 2022 . 21 January 2022.
  278. Web site: Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued August 12 2021 . . 12 August 2021 . https://web.archive.org/web/20210814041706/https://www.fda.gov/media/150386/download . 14 August 2021.
  279. CDC Expands Booster Shot Eligibility and Strengthens Recommendations for 12-17 Year Olds . U.S. Centers for Disease Control and Prevention (CDC) . 5 January 2022 . 5 January 2022 . 6 January 2022 . https://web.archive.org/web/20220106013742/https://www.cdc.gov/media/releases/2022/s0105-Booster-Shot.html . live .
  280. Web site: Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years . U.S. Food and Drug Administration (FDA) . 17 May 2022 . 18 May 2022 . 17 May 2022 . https://web.archive.org/web/20220517235357/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-pfizer-biontech-covid-19-vaccine-booster-dose . live .
  281. Web site: EUA Fact Sheet For Healthcare Providers Administering Vaccine (Vaccination Providers) . PDF . 31 August 2022 . 3 September 2022 . Pfizer .
  282. First adapted COVID-19 booster vaccines recommended for approval in the EU . 1 September 2022 . 3 September 2022 . European Medicines Agency (EMA).
  283. No publication in a peer-reviewed journal but re-published by the ACIP and CDC, see Web site: ACIP Presentation Slides: September 1-2, 2022 Meeting . 17 September 2022 . U.S. Centers for Disease Control and Prevention (CDC) . September 2022.
  284. Web site: Pfizer/BioNTech COVID-19 Omicron-Modified Bivalent Vaccine . 28 June 2022 . 17 September 2022 . U.S. Food and Drug Administration (FDA) . Slide CC-25 . N=8 mice Balb/c mice. Mice preimmunized with 2 doses of BNT162b2; boosters given at day 104 Pseudovirus neutralization assay; LOD, Limit of Detection .
  285. Web site: Pfizer/BioNTech COVID-19 Omicron-Modified Bivalent Vaccine . 1 September 2022 . 17 September 2022 . U.S. Centers for Disease Control and Prevention (CDC) . Slide CC-16 . Mice preimmunized with 2 doses of BNT162b2; boosters given at day 104 post Dose 2 Vaccines administered at 1 mcg dose level; Wild type, Wuhan-Hu-1; LOD ....
  286. Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups . U.S. Food and Drug Administration . 12 October 2022 . 13 October 2022.
  287. Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age . U.S. Food and Drug Administration . 8 December 2022 . 16 December 2022.
  288. Web site: Pfizer-BioNTech COVID-19 Vaccine . U.S. Food and Drug Administration (FDA) . 11 September 2023 . 12 September 2023.
  289. Web site: FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants . U.S. Food and Drug Administration (FDA) . 11 September 2023 . 12 September 2023.
  290. Web site: Regulatory approval of Pfizer/BioNTech vaccine for COVID-19 . . 2 December 2020 . 6 October 2023.
  291. Web site: MHRA approves Pfizer/BioNTech's adapted COVID-19 vaccine (Comirnaty) that targets Omicron XBB.1.5 . . 5 September 2023 . 6 October 2023.
  292. Web site: COVID-19 vaccines safety update . 3 August 2022 . European Medicines Agency (EMA) . 3 August 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  293. ((World Health Organization)) . 2021 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85 . live . WHO Drug Information . 35 . 1 . 259–60 . https://web.archive.org/web/20210419172602/https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-%28inn%29/rl85.pdf . 19 April 2021 . 19 April 2021.
  294. Web site: 23 December 2020 . The inside story behind Pfizer and BioNTech's new vaccine brand name, Comirnaty . live . https://web.archive.org/web/20201225215252/https://www.fiercepharma.com/marketing/pfizer-biontech-select-comirnaty-as-brand-name-for-covid-19-vaccine . 25 December 2020 . 25 December 2020 . FiercePharma . Bulik BS.
  295. BioNTech . Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine . GlobeNewswire . 21 December 2020 . 26 December 2020 . 26 December 2020 . https://web.archive.org/web/20201226213720/https://www.globenewswire.com/news-release/2020/12/21/2148959/0/en/Pfizer-and-BioNTech-Receive-Authorization-in-the-European-Union-for-COVID-19-Vaccine.html . live.
  296. Web site: UNII - JSV288Q5CV . precisionFDA . 6 October 2023.
  297. Web site: Famtozinameran . Inxight Drugs . 6 October 2023.
  298. Web site: Pfizer–BioNTech COVID-19 Vaccine, Bivalent- original and omicron ba.4/ba.5 injection, suspension Pfizer–BioNTech COVID-19 Vaccine- covid-19 vaccine, mrna injection, suspension . DailyMed . 19 September 2023 . 6 October 2023.
  299. Web site: Famtozinameran (Code C190751) . NCI Thesaurus . 25 September 2023 . 6 October 2023.
  300. Web site: COVID-19 vaccines regulatory status . Therapeutic Goods Administration (TGA) . 21 June 2022 . 8 October 2023.
  301. Web site: UNII - N36VHK46PR . precisionFDA . 6 October 2023.
  302. Web site: BNT162b2 Omicron (XBB.1.5) . Inxight Drugs . 6 October 2023.
  303. Web site: INN Proposed List 129 . World Health Organization (WHO) . 1 January 1900 . 6 October 2023.
  304. Web site: Pfizer Inc. 2020 Form 10-K Annual Report . Pfizer . 8 May 2021 . 23 March 2021 . https://web.archive.org/web/20210323212110/https://s21.q4cdn.com/317678438/files/doc_financials/2020/ar/PFE-2020-Form-10K-FINAL.pdf . live .
  305. Web site: Pfizer Inc. 2021 Form 10-K Annual Report . Pfizer . 7 March 2022 . https://web.archive.org/web/20220307052304/https://s28.q4cdn.com/781576035/files/doc_financials/2021/ar/PFE-2021-Form-10K-FINAL.pdf . 7 March 2022 . live .
  306. Web site: 8 February 2022 . Pfizer accused of pandemic profiteering as profits double . Kollewe J . 24 June 2022 . . 30 June 2022 . https://web.archive.org/web/20220630093556/https://www.theguardian.com/business/2022/feb/08/pfizer-covid-vaccine-pill-profits-sales . live .
  307. News: Pfizer's early data shows vaccine is more than 90% effective. Thomas K, Gelles D, Zimmer C. The New York Times. 9 November 2020. 9 November 2020. 23 November 2020. https://web.archive.org/web/20201123032409/https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html. live.
  308. News: 22 July 2020. U.S. to pay Pfizer, BioNTech $1.95 bln for millions of COVID-19 vaccine doses. Reuters. 22 July 2020. Erman M, Ankur B. 22 July 2020. https://web.archive.org/web/20200722171010/https://www.reuters.com/article/us-health-coronavirus-usa-pfizer-idUSKCN24N1I9. live.
  309. 22 July 2020. U.S. Government Engages Pfizer to Produce Millions of Doses of COVID-19 Vaccine. 23 July 2020. US Department of Health and Human Services. 22 July 2020. https://web.archive.org/web/20200722152445/https://www.hhs.gov/about/news/2020/07/22/us-government-engages-pfizer-produce-millions-doses-covid-19-vaccine.html. live.
  310. News: Nazaryan A . So is Pfizer part of Operation Warp Speed or not? Yes and no . 9 November 2020 . Yahoo! . 9 November 2020 . 10 November 2020 . https://web.archive.org/web/20201110052209/https://news.yahoo.com/so-is-pfizer-part-of-operation-warp-speed-or-not-well-its-a-little-complicated-175429888.html . live .
  311. Pfizer and BioNTech Announce an Agreement with U.S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2 . Pfizer . 22 July 2020 . 2 July 2021 . 22 July 2020 . https://web.archive.org/web/20200722181131/https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-agreement-us-government-600 . live .
  312. News: Pleitgen F . EU agrees to buy 300 million doses of the Pfizer/BioNTech Covid-19 vaccine . 26 November 2020 . CNN . 11 November 2020 . 24 November 2020 . https://web.archive.org/web/20201124175829/https://www.cnn.com/2020/11/11/europe/eu-authorizes-contract-biontech-pfizer-vaccine-intl/index.html . live .
  313. Web site: 1 August 2020. Japan and Pfizer reach COVID-19 vaccine deal to treat 60 million people. 21 November 2020. The Japan Times. 10 November 2020. https://web.archive.org/web/20201110142029/https://www.japantimes.co.jp/news/2020/08/01/national/science-health/pfizer-coronavirus-vaccine-deal/. live.
  314. News: Tasker JP . Trudeau says promising new Pfizer vaccine could be 'light at the end of the tunnel' . 9 November 2020 . CBC News . 9 November 2020 . 9 November 2020 . https://web.archive.org/web/20201109170721/https://www.cbc.ca/news/politics/trudeau-pfizer-vaccine-1.5795160 . live .
  315. Web site: Pfizer and BioNTech to Supply Singapore with their BNT162b2 mRNA-based Vaccine Candidate to Combat COVID-19 . pfizer.com.sg . Pfizer Singapore . 1 February 2021 . 14 December 2020 . 27 January 2021 . https://web.archive.org/web/20210127094527/https://www.pfizer.com.sg/pfizer-and-biontech-supply-singapore-vaccine-candidate-combat-covid-19 . live .
  316. Web site: de Salud S. 233. Firma secretario de Salud convenio con Pfizer para fabricación y suministro de vacuna COVID-19. 2 December 2020 . 17 December 2020. gob.mx. es. 24 December 2020. https://web.archive.org/web/20201224154900/https://www.gob.mx/salud/prensa/233-firma-secretario-de-salud-convenio-con-pfizer-para-fabricacion-y-suministro-de-vacuna-covid-19?idiom=es. live.
  317. Web site: 27 August 2020. Fosun Pharma to supply Covid-19 vaccine to Hong Kong, Macau once approved. 21 November 2020. South China Morning Post. 20 November 2020. https://web.archive.org/web/20201120223224/https://www.scmp.com/business/companies/article/3099003/shanghais-fosun-pharma-track-bring-german-partners-covid-19. Ng E . live .
  318. News: Stevis-Gridneff M . How Europe Sealed a Pfizer Vaccine Deal With Texts and Calls . 16 October 2022 . The New York Times . 28 April 2021.
  319. News: European prosecutors take over Belgian probe into Pfizergate . POLITICO . 1 April 2024.
  320. Book: Malpani R, Maitland A . Dose of Reality: How rich countries and pharmaceutical corporations are breaking their vaccine promises . 21 October 2021 . The People's Vaccine Alliance . 24 June 2022 . 18 January 2022 . https://web.archive.org/web/20220118192332/https://webassets.oxfamamerica.org/media/documents/A_Dose_of_Reality-Briefing_Note_kOW1yUs.pdf . live .
  321. Web site: 11 November 2021 . Covid-19: New research reveals Pfizer is making misleading claims about fair distribution of vaccines . 24 June 2022 . Amnesty International . 7 January 2022 . https://web.archive.org/web/20220107211148/https://www.amnesty.org/en/latest/news/2021/11/covid-19-new-research-reveals-pfizer-is-making-misleading-claims-about-fair-distribution-of-vaccines/ . live .
  322. Web site: 12 May 2021 . Pfizer warns Australia a Covid vaccine patent waiver could harm supply and safety . Karp P . 24 June 2022 . . 24 June 2022 . https://web.archive.org/web/20220624182757/https://www.theguardian.com/australia-news/2021/may/13/pfizer-warns-australia-a-covid-vaccine-intellectual-property-patent-waiver-could-harm-supply-and-safety . live .
  323. Web site: Lee J . Do Videos Show Magnets Sticking to People's Arms After COVID-19 Vaccine? . Snopes.com . 7 June 2021 . 14 May 2021 . 9 November 2021 . https://web.archive.org/web/20211109064851/https://www.snopes.com/fact-check/magnets-covid-vaccine/ . live.
  324. Web site: Fichera A . Magnet Videos Refuel Bogus Claim of Vaccine Microchips . FactCheck.org . Annenberg Public Policy Center . 7 June 2021 . 14 May 2021 . 17 May 2021 . https://web.archive.org/web/20210517203524/https://www.factcheck.org/2021/05/scicheck-magnet-videos-refuel-bogus-claim-of-vaccine-microchips/ . live.
  325. Web site: COVID-19 Vaccine Myths And Facts . Los Angeles County Department of Public Health . 15 December 2021 . 27 August 2021 . 25 August 2021 . https://web.archive.org/web/20210825132839/http://publichealth.lacounty.gov/media/Coronavirus/docs/vaccine/VaccineMythsAndFacts.pdf . live .
  326. Web site: Myths and Facts about COVID-19 Vaccines. https://web.archive.org/web/20211211232204/https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html. 11 December 2021 . U.S. Centers for Disease Control and Prevention (CDC) . 27 August 2021 . 18 August 2021 . live .

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