Covaxin

Covaxin
A vial of Covaxin
Vaccine description
TargetSARS-CoV-2
Vaccine typeInactivated
Clinical data
Trade namesCovaxin
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
DrugBank
UNII

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

As of October 2021, 110.6 million people in India have received Covaxin.[1] On 3 November 2021, the World Health Organization (WHO) validated the vaccine for emergency use.[2][3]. As of 31 January 2022, Covaxin has been granted emergency use approval in 13 countries [4]

Medical uses

Effectiveness

A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.[5] Effectiveness is generally expected to slowly decrease over time.[6]

Initial effectiveness by variant
Doses Severity of illness Delta
1 Symptomatic −1% (−51 to 33%)[upper-alpha 1][7]
Hospitalization Not reported
2 Symptomatic 50% (33–62%)[7]
Hospitalization Not reported
  1. ↑ The confidence interval includes zero, so it is possible that vaccination had no effect.

Efficacy

A phase 3 clinical trial with 25,798 participants found that the vaccine is 64% (95% CI, 29–82%) effective against asymptomatic cases, 78% (65–86%) effective against symptomatic disease, 93% (57–100%) effective against severe disease, and 65% (33–83%) effective against the Delta variant.[8]

Manufacturing

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.[9][10]

The vaccine candidate is produced with Bharat Biotech's in-house vero cell manufacturing platform[11] that has the capacity to deliver about 300 million doses.[12] 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.[13][14] Besides this, they are also exploring global tie-ups for Covaxin manufacturing.[15]

In December 2020, Ocugen entered into a partnership with Bharat Biotech to co-develop and exclusively commercialise Covaxin in the US market;[16][17] in June 2021, the partnership was extended to cover Canada.[18] In January 2021, Precisa Med entered into an agreement with Bharat Biotech to supply Covaxin to Brazil.[19]

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[20] whereas Indian Immunologicals Limited (IIL) has signed a commercial agreement with Bharat Biotech for producing the drug substance, a critical component of the vaccine[21] Bharat Immunologicals and Biologicals Corporation (BIBCOL) will also manufacture the vaccine.[22]

History

Clinical trials

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.[23][24] 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.[25] 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.[26][27][28]

In January 2021, the company published Phase I trial results in The Lancet.[29] 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.[30]

Phase III trials

In November 2020, Covaxin received the approval to conduct Phase III human trials[31] after completion of Phase I and II.[32] 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.[33][34][35] 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.[36][37]

Multiple ethical breaches have been reported at one of their trial sites in Bhopal, potentially hampering the quality of overall data.[38][39][40][41]

Phase IV trials

In June 2021, Bharat Biotech announced the start of phase IV trials to evaluate the vaccine's real-world effectiveness.[42] 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.[43]

Trials on minors

In May 2021, Drugs Controller General of India (DCGI) approved clinical trials in the age group of 2 to 18 years.[44] The trials are conducted at AIIMS Delhi and Patna.[45] As many as 54 children had registered at the AIIMS Patna.[46] In total 525 participants are enrolled in the study as per clinical trial data.[47]

Variants

In December 2020, the Alpha variant or lineage B.1.1.7, was identified in the UK.[48] An in vitro study on this variant was carried out and preliminary results show Covaxin to be effective in neutralizing this strain.[49]

In April 2021, the Indian Council of Medical Research reported that the vaccine has shown promising results in neutralizing lineage B.1.617.[50][51]

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).[52]

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.[53][54] Later, the US National Institute of Health also approved the findings where the adjuvant used was developed jointly with funding from NIH.[55][10]

Authorizations

  Full authorization
  Emergency authorization
  Allowed for travel
  Eligible COVAX recipient

India

A vial of Covaxin used at a private hospital in Bengaluru, India

On 6 December 2020, Bharat Biotech applied to the Drugs Controller General of India (DCGI), seeking emergency use authorization.[56] It was the third firm after Serum Institute of India and Pfizer to apply under such provision.[57]

On 2 January 2021, the Central Drugs Standard Control Organization (CDSCO) recommended permission,[58] which was granted the next day.[59] 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.[60] This emergency approval, granted without considering Phase III trial data concerning efficacy and safety, drew widespread criticism.[61][62][63] On 12 October 2021, Bharat Biotech's Covaxin got approved for usage on children between 2 and 18 years of age.[64]

Other nations

The vaccine was also approved for emergency use in Iran and Zimbabwe.[65][66] Nepal granted EUA for Covaxin on 19 March 2021.[67] On 7 April, Mexico gave emergency authorization for Covaxin.[68] On 19 April 2021, Philippines granted EUA to Covaxin.[69] Additionally, Covaxin was granted EUA in Guatemala, Nicaragua, Guyana, Venezuela and Botswana.[70]

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.[71] On 4 June, 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.[72][73][74] On 30 June, Brazilian regulators suspended the deal and an investigation was opened into it by federal prosecutors to probe accusations of irregularity.[75] Anvisa cancelled an ongoing clinical trial of the vaccine on 26 July[76] and suspended the temporary authorization and the import and distribution permit on 27 July.[77]

Mauritius received its first commercial supply of Covaxin on 18 March 2021.[78]

On 29 March 2021, Paraguay received 100,000 doses of Covaxin.[79]

In June 2021, Argentina agreed to buy 10 million doses of Covaxin and administer them to its citizens.[80]

On 3 November 2021, the World Health Organization (WHO) validated the vaccine for emergency use.[2][3]

See also

References

  1. ↑ "Cowin statistics". Cowin. Ministry of health and family welfare India. 23 October 2021. Archived from the original on 9 February 2021.
  2. 1 2 Mitra, Anuron Kumar; Singh, Shivani (3 November 2021). "India's first homegrown COVID-19 shot wins WHO emergency use listing". Reuters. Retrieved 8 November 2021.
  3. 1 2 "WHO issues emergency use listing for eighth COVID-19 vaccine". World Health Organization (WHO) (Press release). Retrieved 3 November 2021.
  4. ↑ "Covaxin granted emergency use approval in 13 countries, Govt informs Parliament". India Today. Retrieved 4 February 2022.
  5. ↑ 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.
  6. ↑ 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.{{cite journal}}: CS1 maint: location (link)
  7. 1 2 Desai D, Khan AR, Soneja M, Mittal A, Naik S, Kodan P, et al. (23 November 2021). "Effectiveness of an inactivated virus-based SARS-CoV-2 vaccine, BBV152, in India: a test-negative, case-control study". The Lancet Infectious Diseases. Table 2. doi:10.1016/S1473-3099(21)00674-5. ISSN 1473-3099. PMC 8610201. PMID 34826383.
  8. ↑ Ella R, Reddy S, Blackwelder W, Potdar V, Yadav P, Sarangi V, et al. (11 November 2021). "Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial". The Lancet. 398 (10317): 2173–2184. doi:10.1016/S0140-6736(21)02000-6. ISSN 0140-6736. PMC 8584828. PMID 34774196.
  9. ↑ Corum J, Zimmer C (26 April 2021). "How Bharat Biotech's Vaccine Works". The New York Times. Retrieved 29 April 2021.
  10. 1 2 "Adjuvant developed with NIH funding enhances efficacy of India's COVID-19 vaccine". National Institutes of Health (NIH). 29 June 2021.
    Public Domain This article incorporates public domain material from websites or documents of the National Institutes of Health.
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  16. ↑ Reuters Staff (22 December 2020). "Ocugen to co-develop Bharat Biotech's COVID-19 vaccine candidate for U.S." Reuters. Retrieved 5 January 2021.
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  52. ↑ 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. 28 (7). doi:10.1093/jtm/taab077. PMC 8194512. PMID 34002240.
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  73. ↑ "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.
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  76. ↑ "Brazil health regulator cancels clinical study for Bharat Biotech vaccine". Reuters. 26 July 2021. Retrieved 16 November 2021.
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