The Phase 3 clinical trial results of Bharat Biotech's coronavirus vaccine candidate, Covaxin, yielded an 81 percent interim efficacy in India.
"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 found effective against the UK variant in the same trials.
Data from the 25,800 participants who received a vaccine or placebo in a 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 old.
“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 said.
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 authorization for the vaccine is currently being secured. At the same time, a clinical trial is being organized to further support available data.
“This is remarkable news for everyone,” IP Biotech Inc. chief operating officer Carlo Garrucho said.
“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 added.