Covaxin produced by Bharat Biotech has shown 77.8% efficacy in reducing symptomatic Covid cases, according to data from the vaccine’s phase three trials. As per reports, on June 22, a Subject Expert Committee (SEC) of the country’s topmost drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), reviewed and accepted data from late-stage clinical trials of Covaxin. SEC’s review and acceptance of this data is expected to offer more credibility to Covaxin’s efficacy against the virus as controversy erupted after it was granted restricted-use permission in January without the phase three trial data.
However, SEC’s approval of the phase three trial data for Covaxin does not mean that it will now be off restricted-use permission. Reports suggest that even though the company wanted complete authorization, it wasn’t agreed to. However, it must be added that no Covid vaccine in the world has full authorisation for market use yet.
The data has been collected from 25,800 participants and also includes information related to the vaccine’s efficacy “for all forms of the disease”, which means the vaccine’s ability to bring down symptomatic Covid-19 cases when compared with those who have not been vaccinated. According to media sources, Bharat Biotech is expected to submit follow-up data on aspects like the safety of the vaccine for at least a year’s time before it is considered for complete authorization and not just for restricted usage.
The results of the phase 3 trials have also come just ahead of Bharat Biotech’s scheduled meeting with the World Health Organization (WHO), where it is expected to submit its proposal for an Emergency Use Listing of the vaccine. The EUL would make it easier for Covaxin to be recognized in other countries where it has not been approved by regulators. An EUL will also facilitate easier international travel for Indians vaccinated with Covaxin.
Senior officials of Bharat Biotech have said that the results from the phase 3 trial of the vaccine will be made available in an international scientific journal “very soon”.
Earlier in March, Bharat Biotech and ICMR had announced that interim results from phase three trials of Covaxin showed that the vaccine has an efficacy of 80.60%. In April, this figure was revised to 78%.