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. 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. 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.
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.
Phase III trialsEdit
In November 2020, Covaxin received the approval to conduct Phase III human trials after completion of Phase I and II. The trial involves a randomised, double-blinded, placebo-controlled study among volunteers of age group 18 and above and started on 25 November. The Phase III trials involved around 26,000 volunteers from across India. The phase III trials covered a total of 22 sites consisting several states in the country, including Delhi, Karnataka and West Bengal. 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.
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. A study on this variant was carried and preliminary results presented in biorxiv have shown Covaxin to be effective in neutralizing this strain.
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 is in talks with other state governments like Odisha for another site in the country to make the vaccine. Beside this, they are also exploring global tie-ups for Covaxin manufacturing.
In December 2020, Ocugen Inc entered a partnership with Bharat Biotech to co-develop Covaxin for the U.S. market. In January 2021, Precisa Med entered an agreement with Bharat Biotech to supply Covaxin in Brazil.
Bharat Biotech has applied to the Drugs Controller General of India (DCGI), Government of India seeking an emergency use authorisation (EUA). It was the third firm after Serum Institute of India and Pfizer to apply for emergency use approval.
On 2 January 2021, the Central Drugs Standard Control Organisation (CDSCO) recommended permission for EUA, which was granted on 3 January. The emergency approval was given before Phase III trial data was published. This was criticized in some sections of the media.
The vaccine was also approved for Emergency Use in Iran and Zimbabwe. Mauritius received its first commercial supply of Covaxin on March 18, 2021. Nepal granted EUA for Covaxin on March 19, 2021. On March 29, 2021, Paraguay received 100,000 doses of covaxin. on 7th April Mexico gave emergency authorization for Covaxin.
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|Scholia has a profile for Covaxin / BBV152 (Q98703813).|
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