Gamaleya Research Institute of Epidemiology and Microbiology explained

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Gamaleya Research Institute of Epidemiology and Microbiology
Formation: (as N. F. Gamaleya Federal Research Center for Epidemiology & Microbiology)
Purpose:Fund vaccine development
Headquarters:18 Gamaleya Street
Moscow, Russia 123098
Leader Title:Director General
Leader Name:Alexander Gintsburg
Parent Organization:Ministry of Health of the Russian Federation
Num Staff:379 (including 92 professors)[1] [2]
Website:
Founder:Filipp Blymenthal[3]

The Gamaleya Research Institute of Epidemiology and Microbiology,[4] previously the N. F. Gamaleya Federal Research Center for Epidemiology & Microbiology, is a Russian medical-research institute within the Ministry of Health of the Russian Federation.[5]

Founded in 1891 by Filipp Markovich Blyumental,[6] it is named after Soviet scientist Nikolay Fyodorovich Gamaleya (1859–1949), famed as a pioneer in microbiology and in vaccine research. The institute is best known internationally for developing the earliest vaccine for SARS-CoV-2, in collaboration with the 48th Central Research Institute of the Ministry of Defence and the Vector Institute of the Rospotrebnadzor, in response to the COVID-19 pandemic.[7] [8]

History

The institution was founded in 1891 as a private bacteriology- and chemical-microscopy-oriented laboratory, which later became the Blumenthal Institute for Bacteriology and Chemistry. It was nationalised in 1919.[9]

Research

Ebola

See main article: GamEvac-Combi. In May 2017, the Institute announced that it would deliver 1,000 doses of its vaccine candidate, GamEvac-Combi,[10] to Guinea for Ebola testing. According to a Xinhua report, it was considered to be an approved Ebola vaccine,[11] although GamEvac-Combi was licensed only in Russia, and did not have a multinational license approved by the World Health Organization, as of November 2019.[12]

COVID-19 vaccine

See main article: Sputnik V COVID-19 vaccine and Sputnik Light. In May 2020, the centre announced that it had developed a COVID-19 vaccine candidate.[13] The project was funded by the Russian National Wealth Fund.[14] A Phase I trial was completed on 18 June 2020 and Phase II was reported as completed in July 2020.[15]

On 11 August 2020, the Russian President Vladimir Putin declared that the institute registered a COVID-19 vaccine called Gam-COVID-Vac.[16]

Protest developed in the international scientific community over the announcement of the vaccine registration in Russia, mainly because there has been no publication of results from clinical trials on Gam-COVID-Vac.[17] [18] At the time of registration, there was no evidence for the safety, effective dose, biomarkers of an immune response, or efficacy against COVID-19 infection.[17] As of 8 August 2020, no reputable scientific report on the Gam-COVID-Vac candidate had been published.[17] [19]

On 4 September 2020, data on 76 participants in the Phase I-II trial were published, indicating preliminary evidence of safety and an immune response.[20] Days later, however, the results were challenged by 27 international vaccine scientists as being incomplete, suspicious, and unreliable, when identical data were reported for many of the trial participants.[21]

On 2 February 2021, results of Phase III clinical trials involving 21,977 participants in Moscow were published in The Lancet, showing 91.6% efficacy of the vaccine,[22] and therefore responding, even if with considerable delays, to previous criticism. The study was subject to considerable criticism by researchers, citing restricted access to research data and inconsistencies in the published data.[23] The authors replied that access had been granted and that inconsistencies were due to typing errors.[24] As registration of the vaccine with Europe's medical regulator EMA dragged on, discussions about data gaps related to the vaccine continued through July 2021.[25]

Notes and References

  1. http://gamaleya.org/index.php/home Национальный исследовательский центр эпидемиологии и микробиологии имени почётного академика Н. Ф. Гамалеи, основанный в 1891 году, является ведущим в своей сфере исследовательским учреждением в мире.
  2. Web site: НИЦЭМ им. Н. Ф. Гамалеи. gamaleya.org.
  3. http://drw.saw-leipzig.de/31229 - "BLJUMENTAL', Filipp Markovič
  4. Russian: Национальный исследовательский центр эпидемиологии и микробиологии имени почётного академика Н. Ф. Гамалеи|Natsional’nyy isslyedovatyel’skiy tsentr epidyemiologii i mikrobiologii imyeni pochetnogo akadyemika N. F. Gamalyei
  5. Other names include the Gamaleya Scientific Research Institute or Gamaleya National Research Center for Epidemiology and Microbiology
  6. https://gamaleya.org/about/istoriya-tsentra/ "1891 г.[:] Частный химико-микроскопический и бактериологический кабинет Ф.М. Блюменталя."
  7. Web site: COVID-19 vaccines by Gamaleya Center, Vektor are most promising. 2020-08-11. TASS.
  8. Web site: 2020-07-13. Russia's COVID-19 vaccine successfully completes first phase of human clinical trials - Health News, Firstpost. 2020-08-11. Firstpost.
  9. Web site: History . Gamaleya Research Institute of Epidemiology and Microbiology . 23 August 2021.
  10. Dolzhikova IV, Zubkova OV, Tukhvatulin AI, Dzharullaeva AS, et al.. Safety and immunogenicity of GamEvac-Combi, a heterologous VSV- and Ad5-vectored Ebola vaccine: An open phase I/II trial in healthy adults in Russia . Human Vaccines & Immunotherapeutics . 13 . 3 . 2017-02-02 . 2164-5515 . 28152326 . 5360131 . 10.1080/21645515.2016.1238535 . 613–620.
  11. Web site: Russia to deliver Ebola vaccines to Guinea by end of June. Xinhua, New China. 18 May 2017. 11 August 2020.
  12. Web site: WHO prequalifies Ebola vaccine, paving the way for its use in high-risk countries . World Health Organization . 15 August 2020 . 12 November 2019.
  13. Web site: Russia plans to start producing coronavirus vaccine in September . . 10 August 2020 . en . 2020-08-11.
  14. Web site: Foy. Henry. 22 July 2020. Russia races for vaccine as Covid-19 nonchalance spreads. 2020-08-16. www.ft.com.
  15. Web site: Russian University Says It Has Finished Human Trials For Covid-19 Vaccine. 2020-08-11.
  16. Web site: 2020-08-11. Putin announces first 'registered' COVID-19 vaccine from Russia's Gamaleya Institute; his daughter among those inoculated - Health News, Firstpost. 2020-08-11. Firstpost.
  17. Callaway . Ewen . Russia's fast-track coronavirus vaccine draws outrage over safety . Nature . 11 August 2020 . 584 . 7821 . 334–335 . 10.1038/d41586-020-02386-2 . 32782400 . 221107555 . en. This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population.. free .
  18. News: Russia's approval of a COVID-19 vaccine is less than meets the press release . Cohen . Jon . Science . 11 August 2020 . 13 August 2020.
  19. News: Scientists ask: Without trial data, how can we trust Russia's COVID vaccine?. Kate Kelland . Reuters . 11 August 2020 . en . 11 August 2020.
  20. Logunov . Denis Y . Dolzhikova . Inna V . etal . Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia . The Lancet . 2020 . 396 . 10255 . 887–897 . 0140-6736 . 10.1016/s0140-6736(20)31866-3 . 32896291 . 7471804 . free .
  21. News: Holly Ellyatt . Scientists question 'strange' data in Russian coronavirus vaccine trial after 'unlikely' patterns . 2020-09-10 . CNBC . 2020-09-10.
  22. Logunov . Denis Y . etal . The Lancet . Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. 2021 . 397 . 10275 . 671–681 . 10.1016/S0140-6736(21)00234-8 . 33545094 . 7852454 . free.
  23. Bucci . Enrico M . etal . The Lancet . Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial. 2021 . 397 . 10288 . 1881–1883 . 10.1016/S0140-6736(21)00899-0. 0140-6736 . 33991475 . 9751705 . free.
  24. Logunov . Denis Y . etal . The Lancet . Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial – Authors' reply. 2021 . 397 . 10288 . 1883–1884 . 10.1016/S0140-6736(21)00894-1 . 33991474 . 8115943 . free.
  25. News: Rose . Michel . Ivanova . Polina. Parodi . Emilio . European efforts to assess Russia's Sputnik V vaccine stymied by data gaps . Reuters . 2021-07-15 . 2021-07-15.

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