The Manila Times

Bharat Biotech's Covaxin Phase 3 interim efficacy at 81%

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BHARAT Biotech recently announced the Phase 3 clinical trial results for its coronaviru­s vaccine candidate, Covaxin. "Covaxin demonstrat­ed 81 percent interim efficacy in preventing Covid-19 in those without prior infection after the second dose," the company said in a statement.

Moreover, the vaccine was also found to be effective against the UK variant of Covid-19 in the same trials.

Data from 25,800 participan­ts who received a vaccine or placebo in 1:1 ratio further showed that the vaccine was well-tolerated. The Phase 3 study enrolled participan­ts from 18 to 98 years of age and as many as 2,433 were over 60 years. At least 4,500 participan­ts had comorbidit­ies. This trial, which was conducted with the Indian

Council of Medical Research, is the largest Covid-19 vaccine trial conducted in India to date “Covaxin demonstrat­es high clinical efficacy trend against Covid-19, but also significan­t immunogeni­city against the rapidly emerging variants," Bharat Biotech Chairman and Managing Director Dr. Krishna Ella emphasized. The vaccine was recently administer­ed to Indian Prime Minister Narendra Modi, as he appealed to all those who are eligible to take the vaccine.

In the Philippine­s, Covaxin will be exclusivel­y distribute­d to the private sector by IP Biotech, Inc. in collaborat­ion with Ambica and Family Vaccine and Specialty Clinics (FVSC — an IP Biotech company). The emergency use approval (EUA) for the vaccine is currently being secured. At the same time, a clinical trial is being organized to further support available data.

Chief Operating Officer of IP Biotech, Inc., Carlo “Roach” Garrucho lauded this latest developmen­t of Covaxin.

“This is remarkable news for everyone,” Garrucho noted. “We expect the very good efficacy results and clinical trial data to support the objective review and acceptance of our regulators, the frontline workforce, and the public at large — especially our vulnerable elderly population. We are confident in the vaccine and look forward to Covaxin being granted an EUA soon,” he concluded.

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