COVAXIN completes enrollment of 25,800 volunteers for phase-3 trials ahead of 'dry run'

In a significant development, Bharat Biotech (BBL) Joint Managing Director Suchitra Ella, on Thursday, said that the company had completed its phase-3 clinical trials enrollment of 25,800 participants. As informed by the ICMR, BBL has already administered 24,000 volunteers with the first shot of its vaccine. The Centre will hold a nationwide dry run in all districts, before rolling out a pan-India inoculation process of the two DCGI-approved vaccines - Covishield and Covaxin.

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COVAXIN completes 3rd phase trial enrollment

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ICMR chief explains COVAXIN approval

Explaining the difference between the two vaccines, he assured that both vaccines were safe, immunogenic and hence approved for emergency usage. He said, "In Covaxin - We have data on animal trials in India showing excellent response in terms of safety, immunogenicity. The phase-1 and phase-2 results on 265 and 380 participants - aged 18 to 55 & age 12 to 65 showed very low adverse events, strong response to all structural proteins including spike. Phase 3 clinical trials with 25,800 participants - 24,000 have been enrolled and there have been no safety concerns, with the first dose given to them."

"5000 have been given their 2nd dose and restricted use for clinical trial mode has been given - which means they have to give consent and there has to be a regular follow-up on participants. The animal studies, phase-1 has been published and Phase 2 & phase-3 are under review," he said adding, "Restricted usage is considered based on safety and immunogenicity while phase-3 is still ongoing in a pandemic situation. Immunogenicity of phase-2 acts as a guide to efficacy when phase-3 is ongoing as per 2019 Clinical trial rules (CTR)."

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DCGI gives nod to COVISHIELD & COVAXIN

On Sunday, Drug Controller General of India (DCGI) VG Somani announced that the vaccines of Serum Institue of India (Covishield) and Bharat Biotech (Covaxin) have been granted permission for restricted use in an emergency situation. Covishield - a Recombinant Chimpanzee Adenovirus vector vaccine - has an efficacy of 70.42%, with interim safety and immunogenicity data of Phase-II/III trials submitted to the SEC. Covaxin - a Whole Virion Inactivated Corona Virus Vaccine - 22,500 participants vaccinated in Phase-III trials and was found to be safe as per the data available till date. Meanwhile, Zydus-Cadilla's nCov-Vaccine using DNA platform technology has been allowed to conduct Phase-III clinical trial in 26000 Indian participants. After a day of heavy politicisation over the vaccines and their approvals, the two manufacturers - Serum Institute of India & Bharat Biotech issued a joint statement pledging global access to their vaccines.

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