BBV152

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BBV152
Vaccine description
Target diseaseCOVID-19
TypeInactivated SARS-CoV-2
Clinical data
Trade namesCovaxin
Routes of
administration		Intramuscular injection
Legal status
Legal status
  • IND: conditional EUA
Identifiers
DrugBank
Part of a series on the
COVID-19 pandemic
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SARS-CoV-2 (Wikimedia colors).svg COVID-19 Portal

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.

Clinical research[edit]

Phase I and II trials[edit]

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]

Phase III trials[edit]

In November 2020, Covaxin received the approval to conduct Phase III human trials[10] after completion of Phase I and II.[11] The trial involves a randomised, double-blinded, placebo-controlled study among volunteers of age group 18 and above and started on 25 November.[12] The Phase III trials will involve around 26,000 volunteers from across India.[13] The phase III trials will cover a total of 22 sites consisting several states in the country, including Delhi, Karnataka and West Bengal, and many other states are expected to join soon.[14]

Manufacturing[edit]

Currently, Bharat Biotech is producing the vaccine candidate via at-risk manufacturing at their vero cell manufacturing platform[15] that has the capacity to deliver about 300 million doses.[16] 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[17] for another site in the country to make the vaccine. Beside this, they are also exploring global tie-ups for Covaxin manufacturing.[18]

Emergency use authorisation[edit]

See also: COVID-19 vaccine § Emergency use authorization

Bharat Biotech has applied to the Drugs Controller General of India (DCGI), Government of India seeking an emergency use authorisation (EUA).[19] It was the third firm after Serum Institute of India and Pfizer to apply for emergency use approval.[20]

On 2 January 2021, the Central Drugs Standard Control Organisation (CDSCO) recommended permission for EUA,[21] which was granted on 3 January.[22]

See also[edit]

References[edit]

  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. ^ "Coronavirus | Covaxin Phase III trial from November". The Hindu. 23 October 2020.
  11. ^ 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)
  12. ^ "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.
  13. ^ "Bharat Biotech begins Covaxin Phase III trials". The Indian Express. 18 November 2020.
  14. ^ Sen M (2 December 2020). "List of states that have started phase 3 trials of India's first Covid vaccine". mint.
  15. ^ 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.
  16. ^ "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.
  17. ^ "Odisha fast tracks coronavirus vaccine manufacturing unit". The New Indian Express. 7 November 2020.
  18. ^ Raghavan P (24 September 2020). "Bharat Biotech exploring global tie-ups for Covaxin manufacturing". The Indian Express.
  19. ^ Ghosh N (7 December 2020). "Bharat Biotech seeks emergency use authorization for Covid-19 vaccine". Hindustan Times.
  20. ^ "Coronavirus | After SII, Bharat Biotech seeks DCGI approval for Covaxin". The Hindu. 7 December 2020.
  21. ^ "Expert panel recommends granting approval for restricted emergency use of Bharat Biotech's Covaxin". The Indian Express. 2 January 2021.
  22. ^ "Coronavirus: India approves vaccines from Bharat Biotech and Oxford/AstraZeneca". BBC News. 3 January 2021. Retrieved 3 January 2021.
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