Bharat Biotech's Covaxin has been granted full Emergency Use Approval (EUA) status by the Food and Drug Administration (FDA), as shared by the consolidator for Covaxin in the Philippines for the private sector, Ambitech Biopharmaceuticals, Inc. (Ambitech). Covaxin had earlier received Emergency Use Approval (EUA) from FDA early on in the second quarter of the year, conditional on its submission of Good Manufacturing Practices (GMP) certification from any PIC/S member country. It was the sixth vaccine in the Philippines to be granted an EUA.
The Philippines was the ninth country to grant the EUA to Covaxin, which has an 81 percent efficacy rate and is a traditional inactivated whole virion vaccine. It is the first indigenously developed Covid-19 vaccine in India by Bharat Biotech in collaboration with the Indian Council of Medical Research. As of publication, 13 countries have granted Covaxin approval for emergency use, with 60 more being processed.
Covaxin has been safely used by millions of people in India's Covid-19 vaccination program, with numerous government officials such as Prime Minister Narendra Modi having received doses of Covaxin in a national campaign to thwart vaccine hesitancy. Brazil's health regulator Agência Nacional de Vigilância Sanitária (Anvisa) recently approved the import of four million doses of Bharat Biotech's Covaxin and went on to grant certification of Good Manufacturing Practices (GMP) to the manufacturing facility as well as its biological output. Brazil is a member country of the Pharmaceutical Inspection Cooperation Scheme (PIC/S).
Ambitech's Director, Deepu Bhatia, shared, "The full EUA status of Covaxin bring us one step closer to making Covaxin available to the Philippines. We thank FDA for the issuance of Covaxin's EUA which is now in line with approvals from other PIC/S member countries from around the world."