Why is Covaxin’s final safety and efficacy report coming only in June? Bharat Biotech clarifies

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Updated: Apr 21, 2021 7:45 PM

The Phase 3 study enrolled 25,800 participants between 18 and 98 years of age, including 10 percent over the age of 60, with analysis conducted 14 days post 2nd dose.

Covid-19 vaccine CovaxinCovaxin was developed with seed strains received from the National Institute of Virology, and the phase 3 clinical trial was co-funded by the Indian Council of Medical Research.

For those awaiting final safety and efficacy results from Bharat Biotech for the Covaxin vaccine, there was some heartening news from the company that showed efficacy numbers in sync with the earlier interim report. A note from the company explaining the second interim report says: “The second interim analysis is based on accruing more than 87 symptomatic cases of COVID-19. Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78 percent against mild, moderate, and severe COVID-19 disease.” Also, it says, “the efficacy against severe COVID-19 disease was 100 percent, with an impact on reduction in hospitalizations. The efficacy against asymptomatic COVID-19 infection was 70 percent, suggesting decreased transmission in Covaxin recipients.”

While the experts are welcoming the news some were wondering what stopped the release of the final report since it meant covering only three more cases? The question, therefore, was that since the original calculated sample size was 130 cases so why stop three short and now wait till June for the final report? Financial Express Online reached out to the company and here is its clarification:

“We have accrued the final requirement of 130 cases as defined in the Efficacy Clinical Trial Protocol. All the data is captured through the Electronic Data Capture system under the supervision of International CRO, IQVIA. Final Data verification and data analysis are being carried out and the final results will be released by June 2021.”

It further says: “The 2nd interim analysis has been done at 127 (beyond two-thirds cases) since we waited till we got enough severe COVID cases, which is a critical parameter to assess the efficacy of COVID vaccines. As this case accrual was happening, due to rapid increase in COVID infections, the total number of cases shot up to 127.”.

Experts while wanting to wait for the full final report, welcomed the second interim report saying that “since more cases have been captured, it is supposed to give more confidence that the results are right.”

In the first interim clinical efficacy report, Bharat Biotech had said that the clinical trial will continue through to final analysis at 130 confirmed cases.

Safety and efficacy results from the final analysis will be available in June, according to the company and the final report will be submitted to a peer-reviewed publication. “Based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of Covaxin,” it also says.

The Phase 3 study enrolled 25,800 participants between 18 and 98 years of age, including 10 percent over the age of 60, with analysis conducted 14 days post 2nd dose. Covaxin was developed with seed strains received from the National Institute of Virology, and the phase 3 clinical trial was co-funded by the Indian Council of Medical Research.

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