Bharat Biotech is going to conduct a phase 4 trial of its COVID-19 vaccine, Covaxin, in order to check the real-world effectiveness. The company revealed that the results for the phase 3 trial will be published next month.
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Hyderabad-based COVID vaccine manufacturer also said that it will publish the phase 3 trial data in July and after that, it will be applying for the full licensure of COVAXIN. It is critical to understand, and further emphasise the Phase-3 data will first be submitted to Central Drugs Standard Control Organisation (CDSCO), followed by peer-reviewed journals, with a timeline of 3 months for publication, and as communicated earlier COVAXIN phase 3 results full trial data will be made public during July. Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for COVAXIN, Bharat Biotech was quoted as saying by ANI on Wednesday.
SEC allows Bharat Biotech to unblind all participants above 45 years
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Recommendation based on the availability of vaccines under the immunisation programme
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Bharat Biotech intends to carry out a phase 3 trial in a cohort in Brazil.
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Recommendation based on the availability of vaccines under the immunisation programme
On March 24, the Subject Expert Committee (SEC) permitted Bharat Biotech to unblind all “participants of age group of more than 45 years and offer to administer the vaccine free of cost as and when they become eligible for the vaccine in the national programme”. The Committee recommended that the company unblind the participants as “vaccines [including Covaxin] are [already] available under the immunisation programme, and therefore all the eligible age groups under the immunisation programme should be permitted for unblinding for vaccination”.
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India s indigenous vaccine COVAXIN has drawn global attention: ICMR
The Indian Council of Medical Research (ICMR) has said that Covaxin has drawn global attention. Covaxin is a COVID-19 vaccine being developed by ICMR-Bharat Biotech. It is now undergoing phase-3 trials.
The ICMR in a tweet said that India s indigenous vaccine has achieved remarkable feat. Data generated from within India underlines impressive safety and immunogenicity profile of Covaxin and sparks Lancet s interest in publishing them. Encouraging Phase I and Phase II COVAXIN trial results have paved the path for Phase III Clinical Trial in India, which is currently ongoing at 22 sites, the ICMR said.