Philippine FDA issues full EUA to Bharat Biotech's Covaxin

Published June 23, 2021, 9:31 AM

by MB Technews


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% efficacy rate and is a traditional inactivated whole virion vaccine.

Covaxin is an inactivated viral vaccine. This vaccine is developed with Whole-Virion Inactivated Vero Cell-derived technology. They contain inactivated viruses, which can not infect a person but still can teach the immune system to prepare a defense mechanism against the active virus.

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, thirteen 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).

In an announcement published on Anvisa’s website, the regulator said “The CBPF (Certification of Good Manufacturing Practices), valid for two years, was issued after [Bharat Biotech] made the adjustments related to non-conformities detected in the inspection carried out by the Agency’s technicians in the period from [earlier] this year.”

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.”The full EUA status of COVAXIN allows for the private sector to now enter into multiparty agreements with the consolidator Ambitech and the national government for the procurement and supply of doses for employees and qualified personnel. This is in accordance with Republic Act 11525.