|Part of a series on the|
A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time.
In July 2021, Bharat Biotech reported the vaccine to be 64% (95% CI, 29–82%) effective against asymptomatic cases, 78% (65–86%) effective against symptomatic cases, 93% (57–100%) effective against severe COVID-19 infection, and 65% (33–83%) effective against the Delta variant.
As an inactivated vaccine, 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 the aluminium-based adjuvant Alhydroxiquim-II.
The vaccine candidate is produced with Bharat Biotech's in-house vero cell manufacturing platform that has the capacity to deliver about 300 million doses. The company is in the process of setting up a second plant at its Genome Valley facility in Hyderabad to make Covaxin. The firm in collaboration with Government of Odisha is establishing another facility at Odisha Biotech Park in Bhubaneswar to commence Covaxin production by June 2022. Besides this, they are also exploring global tie-ups for Covaxin manufacturing.
In December 2020, Ocugen entered into a partnership with Bharat Biotech to co-develop and exclusively commercialise Covaxin in the US market; in June 2021, the partnership was extended to cover Canada. In January 2021, Precisa Med entered into an agreement with Bharat Biotech to supply Covaxin to Brazil.
In May 2021, Haffkine Bio-Pharmaceutical Corporation Limited of Haffkine Institute entered into a memorandum of understanding (MoU) with Bharat Biotech and announced that the production of Covaxin by them will commence after obtaining support from the Maharashtra state government and approval from the Indian government whereas Indian Immunologicals Limited (IIL) has signed a commercial agreement with Bharat Biotech for producing the drug substance, a critical component of the vaccine Bharat Immunologicals and Biologicals Corporation (BIBCOL) will also manufacture the vaccine.
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. In June 2020, the company received permission to conduct Phase I and Phase II human trials of a developmental COVID-19 vaccine codenamed BBV152, from the Drugs Controller General of India (DCGI), Government of India. 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.
In January 2021, the company published Phase I trial results in The Lancet. On 8 March 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.
Phase III trials
In November 2020, Covaxin received the approval to conduct Phase III human trials after completion of Phase I and II. A randomised, double-blinded, placebo-controlled study among volunteers of age group 18 and above, it started on 25 November and involved around 26,000 volunteers from across 22 sites in India. 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.
Phase IV trials
In June 2021, Bharat Biotech announced the start of phase IV trials to evaluate the vaccine's real-world effectiveness. A study of effectiveness and hesitancy study in Healthcare Workers of Max Group of Hospitals at New Delhi from Covaxin and Covishied is under trials.
Trials on minors
In May 2021, Drugs Controller General of India (DCGI) approved clinical trials in the age group of 2 to 18 years. The trials are conducted at AIIMS Delhi and Patna. As many as 54 children had registered at the AIIMS Patna. In total 525 participants are enrolled in the study as per clinical trial data.
In December 2020, the Alpha variant or lineage B.1.1.7, was identified in the UK. An in vitro study on this variant was carried out and preliminary results show Covaxin to be effective in neutralizing this strain.
In May 2021, a joint investigation by the scientists of National Institute of Virology (NIV) India, found the vaccine effective in neutralizing the Zeta variant or lineage P.2 (previously known as B.1.1.28).
In June 2021, a group of researchers at the National Institute of Virology (NIV) India, collected sera from recovered patients and people who had received the Covaxin. They found the vaccine to be effective in neutralizing the Delta (B.1.617.2) and Beta (B.1.351) variants. Later, the US National Institute of Health also approved the findings where the adjuvant used was developed jointly with funding from NIH.
On 6 December 2020, Bharat Biotech applied to the Drugs Controller General of India (DCGI), seeking emergency use authorization. It was the third firm after Serum Institute of India and Pfizer to apply under such provision.
On 2 January 2021, the Central Drugs Standard Control Organization (CDSCO) recommended permission, which was granted the next day. Covaxin was to be used in a "clinical trial mode" i.e. the public vaccination drive was to be an open-label, single-arm clinical trial in itself. This emergency approval, granted without considering Phase III trial data concerning efficacy and safety, drew widespread criticism.On October 12 2021, Bharat Biotech's Covaxin got approved for usage on children between 2 to 18 years of age.
The vaccine was also approved for emergency use in Iran and Zimbabwe. Nepal granted EUA for Covaxin on 19 March 2021. On 7 April, Mexico gave emergency authorization for Covaxin. On 19 April 2021, Philippines granted EUA to Covaxin. Additionally, Covaxin was granted EUA in Guatemala, Nicaragua, Guyana, Venezuela and Botswana.
On 31 March, the Brazilian health regulator Anvisa rejected Bharat Biotech's application for supplying Covaxin in the country due to non-compliance with manufacturing norms. Bharat Biotech stated that they would re-apply after meeting the requirements. On June 4, Anvisa approved exceptional imports of Covaxin, imposing conditions that restrict it mainly to healthy adults and limiting it to just 1% of the country's population to manage the risks through control and supervision of side effects. Anvisa cited as main concerns the incomplete phase III study, a short 45-day follow-up, which should be 60 days to meet the international consensus, and a novel imidazoquinoline adjuvant that may increase the chance of developing an autoimmune disease. On 30 June, Brazilian regulators suspended the deal and an investigation was opened into it by federal prosecutors to probe accusations of irregularity.
On 23 June 2021, Bharat Biotech had submitted 90% of the documentation needed for WHO's EUL.
Mauritius received its first commercial supply of Covaxin on 18 March 2021.
In June 2021, Argentina agreed to buy 10 million doses of Covaxin and administer them to its citizens.
- Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R, Dean NE, et al. (12 September 2020). "COVID-19 vaccine trials should seek worthwhile efficacy". The Lancet. 396 (10253): 741–743. doi:10.1016/S0140-6736(20)31821-3. ISSN 0140-6736. PMC 7832749. PMID 32861315.
WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. Current US Food and Drug Administration guidance includes this lower limit of 30% as a criterion for vaccine licensure.
- Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, et al. (May 2021). "Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection". Nature Medicine. Figure 3. 27 (7): 1205–1211. doi:10.1038/s41591-021-01377-8. ISSN 1546-170X. PMID 34002089. S2CID 234769053.CS1 maint: location (link)
- Suri M, Hollingsworth J (3 July 2021). "India's homegrown Covid-19 vaccine has 78% efficacy against symptomatic infections, developer says". CNN. Retrieved 3 July 2021.
- Ella R, Reddy S, Blackwelder W, Potdar V, Yadav P, Sarangi V, et al. (2 July 2021). "Efficacy, safety, and lot to lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): a double-blind, randomised, controlled phase 3 trial". medRxiv (Preprint). doi:10.1101/2021.06.30.21259439. S2CID 235706046. Retrieved 3 July 2021.
- Corum J, Zimmer C (26 April 2021). "How Bharat Biotech's Vaccine Works". The New York Times. Retrieved 29 April 2021.
- "Adjuvant developed with NIH funding enhances efficacy of India's COVID-19 vaccine". National Institutes of Health (NIH). 29 June 2021.
- 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.
- "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.
- "Odisha sets June 2022 deadline to begin Covaxin production at Andharua". mint. 7 May 2021. Retrieved 19 May 2021.
- "Bhubaneswar: 'Expedite building of Biotech Park near city', says CS Suresh Chandra Mohapatra - Times of India". The Times of India. Retrieved 21 May 2021.
- Raghavan P (24 September 2020). "Bharat Biotech exploring global tie-ups for Covaxin manufacturing". The Indian Express.
- Reuters Staff (22 December 2020). "Ocugen to co-develop Bharat Biotech's COVID-19 vaccine candidate for U.S." Reuters. Retrieved 5 January 2021.
- "Bharat Biotech, Ocugen to co-develop Covaxin for US market". The Economic Times. Retrieved 5 January 2021.
- Swati B (3 June 2021). "Covaxin vaccine: After US market, Bharat Biotech ties up with Ocugen for Covaxin sale in Canada | India News - Times of India". The Times of India. Retrieved 3 July 2021.
- "Bharat Biotech inks pact with Precisa Med to supply Covaxin to Brazil". mint. 12 January 2021.
- "'Will have capacity for 22.8 crore vaccine doses a year', says managing director of Haffkine Institute". The Hindu Business Line. 29 April 2021.
- Bharadwaj S (29 April 2021). "Covid-19 chokes competition in Telangana: Vax makers BB, IIL join hands". The Times of India.
- "BIBCOL to manufacture 2 crore doses of Covaxin every month in UP". The Financial Express. 14 May 2021.
- "ICMR teams up with Bharat Biotech to develop Covid-19 vaccine". Livemint. 9 May 2020.
- Chakrabarti A (10 May 2020). "India to develop 'fully indigenous' Covid vaccine as ICMR partners with Bharat Biotech". ThePrint.
- "India's First COVID-19 Vaccine Candidate Approved for Human Trials". The New York Times. 29 June 2020.
- "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.
- "Asia Today: Amid new surge, India tests potential vaccine". The Washington Post. 25 July 2020. Retrieved 17 December 2020.
- "Delhi: 30-year-old is first to get dose of trial drug Covaxin". The Indian Express. 25 July 2020.
- Ella R, Vadrevu KM, Jogdand H, Prasad S, Reddy S, Sarangi V, et al. (May 2021). "Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial". The Lancet. Infectious Diseases. 21 (5): 637–646. doi:10.1016/S1473-3099(20)30942-7. PMC 7825810. PMID 33485468.
- Ella R, Reddy S, Jogdand H, Sarangi V, Ganneru B, Prasad S, et al. (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. 21 (7): 950–961. doi:10.1016/S1473-3099(21)00070-0. PMC 8221739. PMID 33705727.
- "Covaxin Phase III trial from November". The Hindu. 23 October 2020.
- Ganneru B, Jogdand H, Daram VK, Das D, Molugu NR, Prasad SD, et al. (April 2021). "Th1 skewed immune response of whole virion inactivated SARS CoV 2 vaccine and its safety evaluation". iScience. 24 (4): 102298. Bibcode:2021iSci...24j2298G. doi:10.1016/j.isci.2021.102298. PMC 7944858. PMID 33723528.
- "Bharat Biotech begins Covaxin Phase III trials". The Indian Express. 18 November 2020.
- "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.
- Sen M (2 December 2020). "List of states that have started phase 3 trials of India's first Covid vaccine". mint.
- "70%-80% Drop in Participation For Phase 3 Trials Of Covaxin: Official". NDTV. 17 December 2020.
- "Bharat Biotech's Covaxin given conditional nod based on incomplete Phase 3 trial results data". The Print. 3 January 2021.
- Pulla P (9 February 2021). "Explained: Is the Data From Covaxin Trial's Bhopal Site Tainted?". TheQuint. Retrieved 18 May 2021.
- Bhuyan A (14 January 2021). "How Covaxin Trial Participants in Bhopal Were Misled". The Wire Science. Retrieved 18 May 2021.
- Esha Mitra and Julia Hollingsworth. "More than a dozen slum residents in an Indian city say they didn't know they were part of a clinical vaccine trial". CNN. Retrieved 18 May 2021.
- Bmj IC (January 2021). "India: Doctors call for investigation into allegations of ethical abuse in covid-19 vaccine trial". BMJ. 372: n131. doi:10.1136/bmj.n131. PMID 33446480.
- Bose J (3 July 2021). "Bharat Biotech says completed final analysis for Covaxin, claims 77.8% efficacy". Hindustan Times. Retrieved 3 July 2021.
- "Bharat Biotech plans Covaxin Phase 4 trials, says will meet 'every scientific standard'". CNBC TV18. 10 June 2021. Retrieved 3 July 2021.
- "A prospective, longitudinal, observational, post licensure vaccine evaluation study to assess the effectiveness of COVID-19 vaccine among the Healthcare workers of Max group of hospitals". ctri.nic.in. Clinical Trials Registry India. 24 June 2021. CTRI/2021/01/030782. Retrieved 3 July 2021.
- Bhaduri A (18 May 2021). "Covaxin trials in children between 2 and 18 years to begin in 10-12 days, says Niti Aayog member". Hindustan Times.
- Jaswal M (6 June 2021). "Covaxin: AIIMS Delhi to start trials on children from tomorrow, says report". mint.
- Kumar R (1 June 2021). "Covaxin trials on children begin at AIIMS-Patna". Hindustan Times.
- "A Phase II/III, Open Label, Multicenter Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®) in Healthy Volunteers Ages ≤18 to ≥ 2 Years". ClinicalTrials.gov. United States National Library of Medicine. 26 May 2021. NCT04918797. Retrieved 3 July 2021.
- "Inside the B.1.1.7 Coronavirus Variant". The New York Times. 18 January 2021. Retrieved 29 January 2021.
- Sapkal GN, Yadav PD, Ella R, Deshpande GR, Sahay RR, Gupta N, et al. (June 2021). "Inactivated COVID-19 vaccine BBV152/COVAXIN effectively neutralizes recently emerged B.1.1.7 variant of SARS-CoV-2". Journal of Travel Medicine. 28 (4). doi:10.1093/jtm/taab051. PMC 8083765. PMID 33772577.
- Mascarenhas A (21 April 2021). "Covaxin neutralises double mutant strain of SARS-CoV-2: ICMR study". The Indian Express.
- Yadav PD, Sapkal GN, Abraham P, Ella R, Deshpande G, Patil DY, et al. (May 2021). "Neutralization of variant under investigation B.1.617 with sera of BBV152 vaccinees". Clinical Infectious Diseases. doi:10.1093/cid/ciab411. PMID 33961693.
- Sapkal G, Yadav PD, Ella R, Abraham P, Patil DY, Gupta N, et al. (May 2021). "Neutralization of B.1.1.28 P2 variant with sera of natural SARS-CoV-2 infection and recipients of inactivated COVID-19 vaccine Covaxin". Journal of Travel Medicine. doi:10.1093/jtm/taab077. PMC 8194512. PMID 34002240.
- Sarkar S (9 June 2021). "Covaxin effective in neutralising Delta, Beta variants of Covid-19: Study". Hindustan Times.
- Yadav PD, Sapkal GN, Ella R, Sahay RR, Nyayanit DA, Patil DY, et al. (7 June 2021). "Neutralization against B.1.351 and B.1.617.2 with sera of COVID-19 recovered cases and vaccinees of BBV152". bioRxiv 10.1101/2021.06.05.447177.
- "India's Covaxin effectively neutralises Delta variant of Covid: US' National Institute of Health". The Indian Express. 30 June 2021.
- "Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process". World Health Organization (WHO).
- "WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access". World Health Organization (WHO) (Press release). 31 December 2020. Retrieved 6 January 2021.
- Ghosh N (7 December 2020). "Bharat Biotech seeks emergency use authorization for Covid-19 vaccine". Hindustan Times.
- "After SII, Bharat Biotech seeks DCGI approval for Covaxin". The Hindu. 7 December 2020.
- "Expert panel recommends granting approval for restricted emergency use of Bharat Biotech's Covaxin". The Indian Express. 2 January 2021.
- "Coronavirus: India approves vaccines from Bharat Biotech and Oxford/AstraZeneca". BBC News. 3 January 2021. Retrieved 3 January 2021.
- Mukunth V (29 January 2021). "Covaxin Trial's Info Sheet Skips Mention of Two Rare but Known Risks". The Wire Science. Retrieved 18 May 2021.
- "Disputes Mount, but Heedless Govt Intent on Rolling Vaccine Candidates Out". The Wire. 12 January 2021.
- Thiagarajan K (April 2021). "What do we know about India's Covaxin vaccine?". BMJ. 373: n997. doi:10.1136/bmj.n997. PMID 33879478.
- Pulla P (5 January 2021). "Scientists criticize 'rushed' approval of Indian COVID-19 vaccine without efficacy data". Science | AAAS. Retrieved 18 May 2021.
- "COVID-19: Covaxin Vaccine Approved For Children Between 2 to 18". The Live Mirror. 12 October 2021. Retrieved 12 October 2021.
- Manral K (4 March 2021). "Zimbabwe approves Covaxin, first in Africa to okay India-made Covid-19 vaccine". Hindustan Times. Retrieved 6 March 2021.
- "Iran issues permit for emergency use for three other COVID-19 vaccines: Official". IRNA English. 17 February 2021.
- Sharma G (19 March 2021). "Nepal becomes third country to give emergency nod to Indian vaccine COVAXIN". Reuters. Retrieved 19 March 2021.
- "Mexico authorizes emergency use of Indian COVID-19 vaccine". Reuters. 7 April 2021. Retrieved 7 April 2021.
- "Covaxin, Janssen approved for emergency use in PH". CNN Philippines. 19 April 2021.
- Bharadwaj S (20 April 2021). "Covid-19: Bharat Biotech ramps up Covaxin capacity to 700 million doses per annum". Times of India.
- Som V (31 March 2021). "Brazil Says "No" To Covaxin, Bharat Biotech Explains". NDTV. Retrieved 18 April 2021.
- Mcgeever J, Paraguassu L (4 June 2021). "Brazil's Anvisa approves Russian Sputnik V vaccine, with conditions". Reuters. Retrieved 5 June 2021.
- "Anvisa aprova, com restrições, a importação excepcional de doses da Covaxin e Sputnik V" [Anvisa approves import of doses of Covaxin and Sputnik V, with restrictions]. G1 (in Portuguese). Globo. 4 June 2021. Retrieved 4 June 2021.
- Alegretti L, Barifouse R (4 June 2021). "Covaxin e Sputnik V: O que muda na vacinação do Brasil com decisão da Anvisa" [Covaxin and Sputnik V: What changes in vaccination in Brazil after Anvisa's decision]. BBC Brasil (in Portuguese). Retrieved 5 June 2021.
- "Brazil to suspend vaccine deal with India as graft allegations probed". The Hindu. Reuters. 30 June 2021. Retrieved 30 June 2021.
- Ghosh S (23 June 2021). "WHO's approval for Covaxin: Bharat Biotech's pre-submission meeting today". mint.
- "Dr Jagutpal: Une cargaison de 200 000 vaccins Covaxin débarque demain". L'Express. 19 March 2021.
- "India provides 100,000 doses of Covaxin to Paraguay". 30 March 2021.
- "Buenos Aires Province agrees to buy 10 million doses of Covaxin vaccine". BAT Times. 4 June 2021.
|Scholia has a profile for Covaxin / BBV152 (Q98703813).|
- "How Bharat Biotech's Vaccine Works". The New York Times.