India’s Covaxin secures conditional EUA approval from PH FDA

Published April 20, 2021, 12:30 PM

by Edgard Hilario

Covaxin received Emergency Use Approval (EUA) from the Philippine Food and Drug Administration (FDA), conditional on its submission of Good Manufacturing Practices (GMP) certification from any country that is a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). It is the fourth vaccine in the Philippines to be granted an EUA.

The Philippines is the ninth country to grant the EUA to Covaxin, which has an 81% 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. Covaxin has been safely used by millions of people in India’s COVID-19 vaccination program, with numerous government officials such as the Prime Minister Narendra Modi having received doses of Covaxin in a national campaign to thwart vaccine hesitancy.

IP Biotech, Inc. (IPB) is the exclusive importer and distributor of Covaxin to the Philippines. It has appointed Ambitech Biopharmaceuticals Inc. (Ambitech) as its consolidator.

The granting of the EUA comes as President Duterte and Prime Minister Narendra Modi are set to meet to discuss bilateral relationships that include vaccines and their supply. According to IPB, despite rising COVID-19 cases in India, the country continues its allocation of Covaxin for exports to assist countries that have registered a dire need for vaccines in the fight against COVID-19.

“We thank the Philippine FDA for the stamp of approval for Covaxin which takes us closer to making covaxin available to the Filipino people,” IPB Chairman Enrique Gonzalez enthused. “We feel our eight million dose allocation for the Philippines in 2021 can contribute meaningfully to early vaccination, and our country’s goal of herd immunity. Our next step is to sign multi-party agreement with the national government, as required under Republic Act 11525. Covaxin can arrive in the Philippines within Q2 this year.”

“Ambitech is ready to serve the needs of the Filipino people and to make vaccines available to the private sector on a nationwide basis,” added Ambitech President Kamal Abichandani. “The approval from the FDA is very timely, given that Covaxin was recently declared to be effective against multiple strains, and thus can be a game changer in the overall Philippine vaccination strategy.” Ambitech and Go Negosyo have an on-going collaboration to make Covaxin available to the private sector and msme’s. “We also thank Secretary Joey Concepcion for his support. We believe making vaccines inclusive to the msme sector will help revitalize our economy.” continued Mr. Abichandani.

A strong advocate of Indian vaccines being made available for Filipinos, His Excellency Shambhu S. Kumaran, the Ambassador of India to the Philippines added, “We congratulate the Philippine government on achieving this very important step to making Covaxin available for the Philippines. We truly believe India can be a key partner for the Philippines across many areas, but especially in assisting the country in its fight against COVID-19.”

“Given the current scenario of a rising number of COVID-19 cases in India leading to an even stronger focus on domestic vaccination efforts, we will try our best to supply as many doses as feasible in an early time-frame to our friends in the Philippines,” Amb. Kumaran concluded.