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
Covaxin vial.jpg
A person holding 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
Identifiers
DrugBank
UNII

Clinical researchEdit

Phase I and II trialsEdit

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 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.[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] the report was later published in the The Lancet.[9]

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.[10]

Phase III trialsEdit

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]

As on March 2021, the stated interim efficacy rate for phase III trial is 81%.[18][10]

B.1.1.7 (United Kingdom) variantEdit

In December 2020, a new SARS‑CoV‑2 variant, B.1.1.7, was identified in the UK.[19] A study on this variant was carried and preliminary results presented in biorxiv have shown Covaxin to be effective in neutralizing this strain.[20]

ManufacturingEdit

The vaccine candidate is produced with Bharat Biotech's in-house vero cell manufacturing platform[21] that has the capacity to deliver about 300 million doses.[22] 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[23] for another site in the country to make the vaccine. Beside this, they are also exploring global tie-ups for Covaxin manufacturing.[24]

In December 2020, Ocugen Inc entered a partnership with Bharat Biotech to co-develop Covaxin for the U.S. market.[25][26] In January 2021, Precisa Med entered an agreement with Bharat Biotech to supply Covaxin in Brazil.[27]

Emergency use authorisationEdit

Authorization by country
  Full authorization
  • None
  Emergency authorization

Bharat Biotech has applied to the Drugs Controller General of India (DCGI), Government of India seeking an emergency use authorisation (EUA).[35] It was the third firm after Serum Institute of India and Pfizer to apply for emergency use approval.[36]

On 2 January 2021, the Central Drugs Standard Control Organisation (CDSCO) recommended permission for EUA,[37] which was granted on 3 January.[38] The emergency approval was given before Phase III trial data was published. This was criticized in some sections of the media.[39][40]

The vaccine was also approved for Emergency Use in Iran and Zimbabwe.[30][29] Mauritius received its first commercial supply of Covaxin on March 18, 2021.[31] Nepal granted EUA for Covaxin on March 19, 2021.[32] On March 29, 2021, Paraguay received 100,000 doses of covaxin.[41] on 7th April Mexico gave emergency authorization for Covaxin.[42]

ReferencesEdit

  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. ^ Perappadan, Bindu Shajan (16 December 2020). "Coronavirus | Covaxin phase-1 trial results show promising results". The Hindu. Retrieved 17 December 2020.
  8. ^ Sabarwal, Harshit (16 December 2020). "Covaxin's phase 1 trial result shows robust immune response, mild adverse events". Hindustan Times. Retrieved 17 December 2020.
  9. ^ 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.
  10. ^ 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.
  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. S2CID 221635203. 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. ^ Kumar, N. Ravi (3 March 2021). "Bharat Biotech says COVID-19 vaccine Covaxin shows 81% efficacy in Phase 3 clinical trials". The Hindu.
  19. ^ "Inside the B.1.1.7 Coronavirus Variant". The New York Times. 18 January 2021. Retrieved 29 January 2021.
  20. ^ 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 January 2021). "Neutralization of UK-variant VUI-202012/01 with COVAXIN vaccinated human serum". bioRxiv: 2021.01.26.426986. doi:10.1101/2021.01.26.426986. S2CID 231777157.
  21. ^ 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.
  22. ^ "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.
  23. ^ "Odisha fast tracks coronavirus vaccine manufacturing unit". The New Indian Express. 7 November 2020.
  24. ^ Raghavan P (24 September 2020). "Bharat Biotech exploring global tie-ups for Covaxin manufacturing". The Indian Express.
  25. ^ Reuters Staff (22 December 2020). "Ocugen to co-develop Bharat Biotech's COVID-19 vaccine candidate for U.S." Reuters. Retrieved 5 January 2021.
  26. ^ "Bharat Biotech, Ocugen to co-develop Covaxin for US market". The Economic Times. Retrieved 5 January 2021.
  27. ^ "Bharat Biotech inks pact with Precisa Med to supply Covaxin to Brazil". mint. 12 January 2021.
  28. ^ Schmall E, Yasir S (3 January 2021). "India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Other". The New York Times. Retrieved 3 January 2021.
  29. ^ a b "Iran issues permit for emergency use for three other COVID-19 vaccines: Official". IRNA English. 17 February 2021.
  30. ^ a b Manral, Karan (4 March 2021). "Zimbabwe approves Covaxin, first in Africa to okay India-made Covid-19 vaccine". Hindustan Times. Retrieved 6 March 2021.
  31. ^ a b "Dr Jagutpal: Une cargaison de 200 000 vaccins Covaxin débarque demain". L'Express. 19 March 2021.
  32. ^ a b Sharma, Gopal (19 March 2021). "Nepal becomes third country to give emergency nod to Indian vaccine COVAXIN". Reuters. Retrieved 19 March 2021.
  33. ^ "India provides 100,000 doses of Covaxin vaccine to Paraguay". Hindustan Times. 30 March 2021.
  34. ^ Staff, Reuters (7 April 2021). "Mexico authorizes emergency use of Indian COVID-19 vaccine". Reuters.
  35. ^ Ghosh N (7 December 2020). "Bharat Biotech seeks emergency use authorization for Covid-19 vaccine". Hindustan Times.
  36. ^ "Coronavirus | After SII, Bharat Biotech seeks DCGI approval for Covaxin". The Hindu. 7 December 2020.
  37. ^ "Expert panel recommends granting approval for restricted emergency use of Bharat Biotech's Covaxin". The Indian Express. 2 January 2021.
  38. ^ "Coronavirus: India approves vaccines from Bharat Biotech and Oxford/AstraZeneca". BBC News. 3 January 2021. Retrieved 3 January 2021.
  39. ^ "Disputes Mount, but Heedless Govt Intent on Rolling Vaccine Candidates Out". The Wire. 12 January 2021.
  40. ^ "AIPSN urges govt to reconsider emergency approval for Covaxin till Phase 3 data is published - Health News , Firstpost". Firstpost. 8 January 2021.
  41. ^ "India provides 100,000 doses of Covaxin to Paraguay". 30 March 2021.
  42. ^ Staff, Reuters (7 April 2021). "Mexico authorizes emergency use of Indian COVID-19 vaccine". Reuters. Retrieved 7 April 2021.

External linksEdit