INCOVACC explained

See also: BBV152.

Type:vaccine
Target:SARS-CoV-2
Vaccine Type:viral
Tradename:iNCOVACC
Routes Of Administration:Intranasal
Atc Prefix:None

iNCOVACC (codenamed BBV154)[1] is an intranasal COVID-19 vaccine candidate developed by Bharat Biotech,[2] American company Precision Virologics[3] [4] and the Washington University School of Medicine in St Louis, Missouri, United States.[5] [6]

History

Clinical trials

Phase I trials

On recommendation by the Subject Expert Committee (SEC) under the Indian drug regulator, the company conducted phase 1 clinical trials using 75 volunteers and submit safety and immunogenicity data for the committee's consideration before it proceeds to the second phase of the trial.[7]

Phase II and III trials

On 12 August 2021, after evaluating the results of phase I trial data, the drug regulator approved for phase II/III randomized trials that involves evaluation of the immunogenicity and safety of Covaxin with BBV154 in healthy volunteers.[8]

Authorizations

India

On 24 December 2022, the Government of India approved the intranasal vaccine for inclusion in the vaccination programme as a booster dose for those above 18 years of age.[9] [10]

External links

Notes and References

  1. News: Intranasal Covid vaccine by Bharat Biotech gets approval for booster dose . mint . 28 November 2022 . en.
  2. Web site: Intranasal Vaccine For Covid-19 . Bharat Biotech . 5 March 2021 .
  3. News: St. Louis-based Precision Virologics and India's Biotech leader Bharat Biotech obtain rights to intranasal COVID-19 vaccine technology . 29 August 2021 . www.biostl.org . en.
  4. Hassan AO, Kafai NM, Dmitriev IP, Fox JM, Smith BK, Harvey IB, Chen RE, Winkler ES, Wessel AW, Case JB, Kashentseva E, McCune BT, Bailey AL, Zhao H, VanBlargan LA, Dai YN, Ma M, Adams LJ, Shrihari S, Danis JE, Gralinski LE, Hou YJ, Schäfer A, Kim AS, Keeler SP, Weiskopf D, Baric RS, Holtzman MJ, Fremont DH, Curiel DT, Diamond MS . 6 . A Single-Dose Intranasal ChAd Vaccine Protects Upper and Lower Respiratory Tracts against SARS-CoV-2 . Cell . 183 . 1 . 169–184.e13 . October 2020 . 32931734 . 7437481 . 10.1016/j.cell.2020.08.026 .
  5. News: Bharat Biotech to make a billion doses of an intranasal adenovirus vaccine . The Indian Express . 23 September 2020 . en . 23 September 2020 . 3 May 2021 . https://web.archive.org/web/20210503051133/https://indianexpress.com/article/india/bharat-biotech-to-manufacture-a-billion-doses-of-nasal-spray-covid-19-vaccine-6607305/ . live .
  6. News: Bharat Biotech Partners With US University For Covid Intranasal Vaccine . NDTV.com . 23 September 2020 . 3 May 2021 . https://web.archive.org/web/20210503140735/https://www.ndtv.com/india-news/bharat-biotech-partners-with-us-university-for-covid-intranasal-vaccine-2299947 . live .
  7. News: Raghavan P . Explained: Understanding BBV154, Bharat Biotech's single-dose intranasal Covid-19 vaccine . The Indian Express . 30 January 2021 . en.
  8. News: Gaurav K . First nasal vaccine developed by Bharat Biotech gets nod for Phase 2/3 trial . Hindustan Times . 13 August 2021 . en.
  9. News: Intranasal vaccine gets clearance as booster option in Covid fight . The Indian Express . 24 December 2022 . en.
  10. News: World's first intranasal covid vaccine to be available in India as booster dose from today . . 24 December 2022 . en.

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