BBV152

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See also: COVID-19 vaccination in India

BBV152
Covaxin vial.jpg
A vial of the Covaxin vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeInactivated
Clinical data
Trade namesCovaxin
Routes of
administration		Intramuscular
ATC code
  • None
Legal status
Legal status
  • EUA : IND, IRN, ZWE, MU, NP, PY, MX, PH, MM, GT, NI, GY, VE, BW
Identifiers
DrugBank
UNII
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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.

Technology[edit]

As an inactivated vaccine like BBIBP-CorV and CoronaVac, Covaxin uses a more traditional technology that is similar to the inactivated polio vaccine. Initially, a sample of SARS-CoV-2 was isolated by India's National Institute of Virology and used to grow large quantities of the virus using vero cells. From then on, the viruses are soaked in beta-propiolactone, which deactivates them by binding to their genes, while leaving other viral particles intact. The resulting inactivated viruses are then mixed with an aluminium-based adjuvant.[1]

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.[2][3] In June 2020, the company received permission to conduct Phase I and Phase II human trials of a developmental COVID-19 vaccine named Covaxin, from the Drugs Controller General of India (DCGI), Government of India.[4] 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.[5][6][7]

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

On March 8, 2021, Phase II results were published in The Lancet. The study showed that Phase II trials had a higher immune response and induced T-cell response due to the difference in dosing regime from Phase I. The doses in Phase II were given at 4 weeks interval as opposed to 2 weeks in Phase I. Neutralization response of the vaccine were found significantly higher in Phase II.[11]

Phase III trials[edit]

In November 2020, Covaxin received the approval to conduct Phase III human trials[12] after completion of Phase I and II.[13] The trial involves a randomised, double-blinded, placebo-controlled study among volunteers of age group 18 and above and started on 25 November.[14] The Phase III trials involved around 26,000 volunteers from across India.[15] The phase III trials covered a total of 22 sites consisting several states in the country, including Delhi, Karnataka and West Bengal.[16] 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.[17][18]

As on March 2021, the stated interim efficacy rate for phase III trial is 81%.[19][11] In April 2021, Bharat Biotech reported that efficacy dropped to 78%, in its interim analysis of its phase 3 trial.[20][unreliable medical source?]

B.1.1.7 (United Kingdom) variant[edit]

In December 2020, a new SARS‑CoV‑2 variant, B.1.1.7, was identified in the UK.[21] A study on this variant was carried and preliminary results presented in Journal of Travel Medicine have shown Covaxin to be effective in neutralizing this strain.[22]

B.1.617 (Indian) variant[edit]

In April 2021, Indian Council of Medical Research has reported that the vaccine has shown promising results in neutralizing against the strain B.1.617.[23][24]

Manufacturing[edit]

The vaccine candidate is produced with Bharat Biotech's in-house vero cell manufacturing platform[25] that has the capacity to deliver about 300 million doses.[26] 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[27] for another site in the country to make the vaccine. Beside this, they are also exploring global tie-ups for Covaxin manufacturing.[28]

In December 2020, Ocugen Inc entered a partnership with Bharat Biotech to co-develop Covaxin for the U.S. market.[29][30] In January 2021, Precisa Med entered an agreement with Bharat Biotech to supply Covaxin in Brazil.[31]

In April 2021, Haffkine Institute procured manufacturing rights via technology transfer from ICMR to produce the vaccine in India in addition to Bharat Biotech.[32] Indian Immunologicals Limited (IIL) has also confirmed to start rolling out the vaccine from July - August 2021 onwards.[33]

Usage authorization[edit]

  Full authorization
  Emergency authorization
See also: List of COVID-19 vaccine authorizations § Covaxin, and COVID-19 vaccine § Trial and authorization status

Bharat Biotech has applied to the Drugs Controller General of India (DCGI), Government of India seeking an emergency use authorisation (EUA).[34] It was the third firm after Serum Institute of India and Pfizer to apply for emergency use approval.[35]

On 2 January 2021, the Central Drugs Standard Control Organisation (CDSCO) recommended permission for EUA,[36] which was granted on 3 January.[37] The emergency approval was given before Phase III trial data was published. This was criticized in some sections of the media.[38][39]

The vaccine was also approved for Emergency Use in Iran and Zimbabwe.[40][41] Mauritius received its first commercial supply of Covaxin on March 18, 2021.[42] Nepal granted EUA for Covaxin on March 19, 2021.[43] On March 29, 2021, Paraguay received 100,000 doses of covaxin.[44] On 7 April Mexico gave emergency authorization for Covaxin.[45] On 19 April 2021, Philippines granted EUA to Covaxin.[46] Additionally, Covaxin was granted EUA in Guatemala, Nicaragua, Guyana, Venezuela, Botswana.[47]

The Brazilian Health Regulatory Agency rejected Bharat Biotech's application for supplying Covaxin in the country due to non-compliance with the manufacturing norms for medicine. Bharat Biotech stated that they would reapply after meeting their requirements.[48]

References[edit]

  1. ^ Corum, Jonathan; Zimmer, Carl (26 April 2021). "How Bharat Biotech's Vaccine Works". The New York Times. ISSN 0362-4331. Retrieved 29 April 2021.
  2. ^ "ICMR teams up with Bharat Biotech to develop Covid-19 vaccine". Livemint. 9 May 2020.
  3. ^ Chakrabarti A (10 May 2020). "India to develop 'fully indigenous' Covid vaccine as ICMR partners with Bharat Biotech". ThePrint.
  4. ^ "India's First COVID-19 Vaccine Candidate Approved for Human Trials". The New York Times. 29 June 2020.
  5. ^ "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.
  6. ^ Press, Associated (25 July 2020). "Asia Today: Amid new surge, India tests potential vaccine". Washington Post. Retrieved 17 December 2020.
  7. ^ "Delhi: 30-year-old is first to get dose of trial drug Covaxin". The Indian Express. 25 July 2020.
  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. PMC 7825810. PMID 33485468.
  11. ^ a b Ella, Raches; Reddy, Siddhart; Jogdand, Harsh; Sarangi, Vamsi; Ganneru, Brunda; Prasad, Sai; Das, Dipankar; Dugyala, Raju; Praturi, Usha; Sakpal, Gajanan; Yadav, Pragya; Reddy, Prabhakar; Verma, Savita; Singh, Chandramani; Redkar, Sagar Vivek; Singh, Chandramani; Gillurkar, Chandra Sekhar; Kushwaha, Jitendra Singh; Mohapatra, Satyajit; Mohapatra, Satyajit; Bhate, Amit; Rai, Sanjay; Panda, Samiran; Abraham, Priya; Gupta, Nivedita; Ella, Krishna; Bhargav, Balram; Vadrevu, Krishna Mohan (8 March 2021). "Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial". The Lancet Infectious Diseases. doi:10.1016/S1473-3099(21)00070-0. PMID 33705727.
  12. ^ "Coronavirus | Covaxin Phase III trial from November". The Hindu. 23 October 2020.
  13. ^ Ganneru, Brunda; Jogdand, Harsh; Daram, Vijaya Kumar; Das, Dipankar; Molugu, Narasimha Reddy; Prasad, Sai D.; Kannappa, Srinivas V.; Ella, Krishna M.; Ravikrishnan, Rajaram; Awasthi, Amit; Jose, Jomy; Rao, Panduranga; Kumar, Deepak; Ella, Raches; Abraham, Priya; Yadav, Pragya D.; Sapkal, Gajanan N.; Shete-Aich, Anita; Desphande, Gururaj; Mohandas, Sreelekshmy; Basu, Atanu; Gupta, Nivedita; Vadrevu, Krishna Mohan (23 April 2021). "Th1 skewed immune response of whole virion inactivated SARS CoV 2 vaccine and its safety evaluation". iScience. 24 (4). doi:10.1016/j.isci.2021.102298. ISSN 2589-0042. PMC 7944858. PMID 33723528.
  14. ^ "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.
  15. ^ "Bharat Biotech begins Covaxin Phase III trials". The Indian Express. 18 November 2020.
  16. ^ Sen M (2 December 2020). "List of states that have started phase 3 trials of India's first Covid vaccine". mint.
  17. ^ "70%-80% Drop In Participation For Phase 3 Trials Of Covaxin: Official". NDTV. 17 December 2020.
  18. ^ "Bharat Biotech's Covaxin given conditional nod based on incomplete Phase 3 trial results data". The Print. 3 January 2021.
  19. ^ Kumar, N. Ravi (3 March 2021). "Bharat Biotech says COVID-19 vaccine Covaxin shows 81% efficacy in Phase 3 clinical trials". The Hindu.
  20. ^ Koshy, Jacob (21 April 2021). "Coronavirus | Updated data from Covaxin phase 3 trial shows 78% efficacy". The Hindu. ISSN 0971-751X. Retrieved 24 April 2021.
  21. ^ "Inside the B.1.1.7 Coronavirus Variant". The New York Times. 18 January 2021. Retrieved 29 January 2021.
  22. ^ Sapkal, Gajanan N; Yadav, Pragya D; Ella, Raches; Deshpande, Gururaj R; Sahay, Rima R; Gupta, Nivedita; Mohan, V Krishna; Abraham, Priya; Panda, Samiran; Bhargava, Balram (27 March 2021). "Inactivated COVID-19 vaccine BBV152/COVAXIN effectively neutralizes recently emerged B 1.1.7 variant of SARS-CoV-2". Journal of Travel Medicine. doi:10.1093/jtm/taab051. ISSN 1708-8305. PMID 33772577.
  23. ^ Mascarenhas, Anuradha (21 April 2021). "Covaxin neutralises double mutant strain of SARS-CoV-2: ICMR study". The Indian Express.
  24. ^ Yadav, Pragya D.; Sapkal, Gajanan N.; Abraham, Priya; Ella, Raches; Deshpande, Gururaj; Patil, Deepak Y.; Nyayanit, Dimpal A.; Gupta, Nivedita; Sahay, Rima R.; Shete, Anita M.; Panda, Samiran; Bhargava, Balram; Mohan, V. Krishna (23 April 2021). "Neutralization of variant under investigation B.1.617 with sera of BBV152 vaccinees". bioRxiv: 2021.04.23.441101. doi:10.1101/2021.04.23.441101.
  25. ^ 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. PMC 5890396. PMID 29555218.
  26. ^ "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.
  27. ^ "Odisha fast tracks coronavirus vaccine manufacturing unit". The New Indian Express. 7 November 2020.
  28. ^ Raghavan P (24 September 2020). "Bharat Biotech exploring global tie-ups for Covaxin manufacturing". The Indian Express.
  29. ^ Reuters Staff (22 December 2020). "Ocugen to co-develop Bharat Biotech's COVID-19 vaccine candidate for U.S." Reuters. Retrieved 5 January 2021.
  30. ^ "Bharat Biotech, Ocugen to co-develop Covaxin for US market". The Economic Times. Retrieved 5 January 2021.
  31. ^ "Bharat Biotech inks pact with Precisa Med to supply Covaxin to Brazil". mint. 12 January 2021.
  32. ^ Deshpande, Alok (15 April 2021). "Haffkine Institute gets Centre's nod to produce Covaxin". The Hindu. Retrieved 15 April 2021.
  33. ^ Vora, Rutam (20 April 2021). "IIL confident of Covaxin rollout by August". @businessline. The Hindu.
  34. ^ Ghosh N (7 December 2020). "Bharat Biotech seeks emergency use authorization for Covid-19 vaccine". Hindustan Times.
  35. ^ "Coronavirus | After SII, Bharat Biotech seeks DCGI approval for Covaxin". The Hindu. 7 December 2020.
  36. ^ "Expert panel recommends granting approval for restricted emergency use of Bharat Biotech's Covaxin". The Indian Express. 2 January 2021.
  37. ^ "Coronavirus: India approves vaccines from Bharat Biotech and Oxford/AstraZeneca". BBC News. 3 January 2021. Retrieved 3 January 2021.
  38. ^ "Disputes Mount, but Heedless Govt Intent on Rolling Vaccine Candidates Out". The Wire. 12 January 2021.
  39. ^ "AIPSN urges govt to reconsider emergency approval for Covaxin till Phase 3 data is published - Health News , Firstpost". Firstpost. 8 January 2021.
  40. ^ Manral, Karan (4 March 2021). "Zimbabwe approves Covaxin, first in Africa to okay India-made Covid-19 vaccine". Hindustan Times. Retrieved 6 March 2021.
  41. ^ "Iran issues permit for emergency use for three other COVID-19 vaccines: Official". IRNA English. 17 February 2021.
  42. ^ "Dr Jagutpal: Une cargaison de 200 000 vaccins Covaxin débarque demain". L'Express. 19 March 2021.
  43. ^ Sharma, Gopal (19 March 2021). "Nepal becomes third country to give emergency nod to Indian vaccine COVAXIN". Reuters. Retrieved 19 March 2021.
  44. ^ "India provides 100,000 doses of Covaxin to Paraguay". 30 March 2021.
  45. ^ Staff, Reuters (7 April 2021). "Mexico authorizes emergency use of Indian COVID-19 vaccine". Reuters. Retrieved 7 April 2021.
  46. ^ "Covaxin, Janssen approved for emergency use in PH". CNN Philippines. 19 April 2021.
  47. ^ Bharadwaj, Swati (20 April 2021). "Covid-19: Bharat Biotech ramps up Covaxin capacity to 700 million doses per annum". Times of India.
  48. ^ Som, Vishnu (31 March 2021). "Brazil Says "No" To Covaxin, Bharat Biotech Explains". NDTV. Retrieved 18 April 2021.

External links[edit]

Retrieved from "https://en.wikipedia.org/w/index.php?title=BBV152&oldid=1021418171"