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Covaxin shows 77.8% efficacy a day before company meets WHO officials

Bharat Biotech International’s Covaxin vaccine showed 77.8% efficacy in preventing symptoms of covid-19, a person aware of the matter said, citing interim phase 3 trial data submitted by the company to a regulatory panel.

The efficacy data was reviewed and accepted by the subject expert committee (SEC) of the national regulator Central Drugs Standards Control Organisation (CDSCO) in its meeting on Tuesday, the person said, requesting anonymity.

The findings are similar to the interim results announced by Bharat Biotech in April when it said its indigenously developed vaccine had an efficacy of 78% in preventing symptomatic covid-19. At the time, the company said Covaxin is 100% effective in preventing severe disease. Mint was unable to verify the claim.

Spokespeople for the Hyderabad-based Bharat Biotech and the health ministry did not comment on the SEC meeting. Drugs Controller General of India V.G. Somani, who heads CDSCO, did not respond to calls and messages.

The SEC meeting comes a day before Bharat Biotech’s scheduled pre-submission meeting for an emergency use listing (EUL) with officials of the World Health Organization (WHO). According to a WHO document updated on 16 June, the company is expected to meet regulatory officials from the multilateral agency before submitting the data.

The lack of EUL for Covaxin has led to hurdles in receiving recognition in countries where Bharat Biotech does not have regulatory authorization. News reports have said that the US and several nations in Europe are asking those administered with Covaxin to get revaccinated with a WHO-approved vaccine such as the one developed by AstraZeneca Plc or those from Pfizer Inc., Moderna Inc. or Johnson and Johnson.

Bharat Biotech has been criticized by experts for not making its efficacy data public, even though it issued its first set of interim data in March, followed by an update in the following month.

The company is yet to publish its detailed phase 3 efficacy data.

The first interim data, announced in a press release on 3 March, showed the vaccine had an efficacy of 80.6%, which was revised to 78% in the 21 April update. Both announcements were made in press releases, with the lack of disclosures of the fine print in the following months being criticized by public health experts.

The vaccine maker defended itself, saying it is the only Indian company to publish data from animal testing and the first two phases of human studies as preprints and in peer-reviewed journals.

On efficacy data, Dr. Raches Ella, the company’s project lead for covid-19 vaccines, said on 9 June that sufficient data on the vaccines was collected by mid-May, two months after the last participant was given the second dose of the vaccine, and analysis and publishing of the data could take an additional two to four months.

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