BBV152

BBV152 (also known as Covaxin) is an inactivated virus based COVID-19 vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.

BBV152
A person holding a vial of the Covaxin vaccine
Vaccine description
Target diseaseCOVID-19
TypeKilled/Inactivated
Clinical data
Trade namesCovaxin
Routes of
administration		Intramuscular
ATC code
  • None
Legal status
Legal status
  • IND: conditional EUA
Identifiers
DrugBank
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Clinical research

Phase I and II trials

In May 2020, Indian Council of Medical Research's (ICMR's) National Institute of Virology approved and provided the virus strains for developing a fully indigenous COVID-19 vaccine.[1][2] In June 2020, the company got permission to conduct Phase 1 and Phase 2 human trials of a developmental COVID-19 vaccine named Covaxin, from the Drugs Controller General of India (DCGI), Government of India.[3] A total of 12 sites were selected by the Indian Council for Medical Research for Phase I and II randomised, double-blind and placebo-controlled clinical trials of vaccine candidate.[4][5][6]

In December 2020, the company announced the report for Phase I trials and presented the results through medRxiv preprint;[7][8][9] the report was later published in the The Lancet.[10]

Phase III trials

In November 2020, Covaxin received the approval to conduct Phase III human trials[11] after completion of Phase I and II.[12] The trial involves a randomised, double-blinded, placebo-controlled study among volunteers of age group 18 and above and started on 25 November.[13] The Phase III trials involved around 26,000 volunteers from across India.[14] The phase III trials covered a total of 22 sites consisting several states in the country, including Delhi, Karnataka and West Bengal.[15] Refusal rate for Phase III trials was much higher than that for Phase I and Phase II. As a result only 13,000 volunteers had been recruited by 22 December with the number increasing to 23,000 by 5 January.[16][17][18]

Manufacturing

Bharat Biotech is producing the vaccine candidate via at-risk manufacturing at their vero cell manufacturing platform[19] that has the capacity to deliver about 300 million doses.[20] The company is in the process of setting up a second plant at its Genome Valley facility in Hyderabad to make Covaxin. The firm is in talks with other state governments like Odisha[21] for another site in the country to make the vaccine. Beside this, they are also exploring global tie-ups for Covaxin manufacturing.[22]

In December 2020, Ocugen Inc entered a partnership with Bharat Biotech to co-develop Covaxin for the U.S. market.[23][24]

In January 2021, Precisa Med entered an agreement with Bharat Biotech to supply Covaxin in Brazil[25]

Emergency use authorisation
See also: COVID-19 vaccine § Authorized and approved vaccines

Bharat Biotech has applied to the Drugs Controller General of India (DCGI), Government of India seeking an emergency use authorisation (EUA).[26] It was the third firm after Serum Institute of India and Pfizer to apply for emergency use approval.[27]

On 2 January 2021, the Central Drugs Standard Control Organisation (CDSCO) recommended permission for EUA,[28] which was granted on 3 January.[29] The emergency approval was given before Phase III trial data was published. This was criticized in some sections of the media.[30][18]

References
  1. "ICMR teams up with Bharat Biotech to develop Covid-19 vaccine". Livemint. 9 May 2020.
  2. Chakrabarti A (10 May 2020). "India to develop 'fully indigenous' Covid vaccine as ICMR partners with Bharat Biotech". ThePrint.
  3. "India's First COVID-19 Vaccine Candidate Approved for Human Trials". The New York Times. 29 June 2020.
  4. "Human clinical trials of potential Covid-19 vaccine 'COVAXIN' started at AIIMS". DD News. Prasar Bharati, Ministry of I & B, Government of India. 25 July 2020.
  5. Press, Associated (25 July 2020). "Asia Today: Amid new surge, India tests potential vaccine". Washington Post. Retrieved 17 December 2020.
  6. "Delhi: 30-year-old is first to get dose of trial drug Covaxin". The Indian Express. 25 July 2020.
  7. Ella, Raches; Mohan, Krishna; Jogdand, Harsh; Prasad, Sai; Reddy, Siddharth; Sarangi, Vamshi Krishna; Ganneru, Brunda; Sapkal, Gajanan; Yadav, Pragya; Panda, Samiran; Gupta, Nivedita; Reddy, Prabhakar; Verma, Savita; Rai, Sanjay; Singh, Chandramani; Redkar, Sagar; Gillurkar, Chandra Sekhar; Kushwaha, Jitendra Singh; Rao, Venkat; Mohapatra, Satyajit; Guleria, Randeep; Ella, Krishna; Bhargava, Balram (15 December 2020). "Safety and immunogenicity trial of an inactivated SARS-CoV-2 vaccine-BBV152: a phase 1, double-blind, randomised control trial". medRxiv. doi:10.1101/2020.12.11.20210419.
  8. Perappadan, Bindu Shajan (16 December 2020). "Coronavirus | Covaxin phase-1 trial results show promising results". The Hindu. Retrieved 17 December 2020.
  9. Sabarwal, Harshit (16 December 2020). "Covaxin's phase 1 trial result shows robust immune response, mild adverse events". Hindustan Times. Retrieved 17 December 2020.
  10. Ella, Raches; Vadrevu, Krishna Mohan; Jogdand, Harsh; Prasad, Sai; Reddy, Siddharth; Sarangi, Vamshi; Ganneru, Brunda; Sapkal, Gajanan; Yadav, Pragya; Abraham, Priya; Panda, Samiran; Gupta, Nivedita; Reddy, Prabhakar; Verma, Savita; Rai, Sanjay Kumar; Singh, Chandramani; Redkar, Sagar Vivek; Gillurkar, Chandra Sekhar; Kushwaha, Jitendra Singh; Mohapatra, Satyajit; Rao, Venkat; Guleria, Randeep; Ella, Krishna; Bhargava, Balram (21 January 2021). "Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial". The Lancet Infectious Diseases. doi:10.1016/S1473-3099(20)30942-7.
  11. "Coronavirus | Covaxin Phase III trial from November". The Hindu. 23 October 2020.
  12. Ganneru B, Jogdand H, Daram VK, Molugu NR, Prasad SD, Kannappa SV, et al. (9 September 2020). "Evaluation of Safety and Immunogenicity of an Adjuvanted, TH-1 Skewed, Whole Virion InactivatedSARS-CoV-2 Vaccine - BBV152". doi:10.1101/2020.09.09.285445. Cite journal requires |journal= (help)
  13. "An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers". clinicaltrials.gov (Registry). United States National Library of Medicine. NCT04641481. Retrieved 26 November 2020.
  14. "Bharat Biotech begins Covaxin Phase III trials". The Indian Express. 18 November 2020.
  15. Sen M (2 December 2020). "List of states that have started phase 3 trials of India's first Covid vaccine". mint.
  16. "70%-80% Drop In Participation For Phase 3 Trials Of Covaxin: Official". NDTV. 17 December 2020.
  17. "Bharat Biotech's Covaxin given conditional nod based on incomplete Phase 3 trial results data". The Print. 3 January 2021.
  18. "Covaxin phase-3 trials to end today, average efficacy 60-70%". Deccan Herald. 5 January 2021.
  19. Hoeksema F, Karpilow J, Luitjens A, Lagerwerf F, Havenga M, Groothuizen M, et al. (April 2018). "Enhancing viral vaccine production using engineered knockout vero cell lines - A second look". Vaccine. 36 (16): 2093–2103. doi:10.1016/j.vaccine.2018.03.010. PMID 29555218.
  20. "Coronavirus vaccine update: Bharat Biotech's Covaxin launch likely in Q2 of 2021, no word on pricing yet". www.businesstoday.in. India Today Group. Retrieved 13 December 2020.
  21. "Odisha fast tracks coronavirus vaccine manufacturing unit". The New Indian Express. 7 November 2020.
  22. Raghavan P (24 September 2020). "Bharat Biotech exploring global tie-ups for Covaxin manufacturing". The Indian Express.
  23. Reuters Staff (22 December 2020). "Ocugen to co-develop Bharat Biotech's COVID-19 vaccine candidate for U.S." Reuters. Retrieved 5 January 2021.
  24. "Bharat Biotech, Ocugen to co-develop Covaxin for US market". The Economic Times. Retrieved 5 January 2021.
  25. "Bharat Biotech inks pact with Precisa Med to supply Covaxin to Brazil". mint. 12 January 2021.
  26. Ghosh N (7 December 2020). "Bharat Biotech seeks emergency use authorization for Covid-19 vaccine". Hindustan Times.
  27. "Coronavirus | After SII, Bharat Biotech seeks DCGI approval for Covaxin". The Hindu. 7 December 2020.
  28. "Expert panel recommends granting approval for restricted emergency use of Bharat Biotech's Covaxin". The Indian Express. 2 January 2021.
  29. "Coronavirus: India approves vaccines from Bharat Biotech and Oxford/AstraZeneca". BBC News. 3 January 2021. Retrieved 3 January 2021.
  30. "Disputes Mount, but Heedless Govt Intent on Rolling Vaccine Candidates Out". The Wire. 12 January 2021.
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