MANILA, Philippines — India’s Bharat Biotech submitted an application for the emergency use of its COVID-19 vaccine in the Philippines, the country’s Food and Drug Administration said Thursday.
Bharat Biotech, which partnered with the Indian Council of Medical Research and National Institute of Virology to develop Covaxin, was the fourth pharmaceutical firm to apply for EUA in the country.
“They submitted an application this morning and pre-evaluation is going on,” FDA Director General told Philstar.com in a text message
Covaxin is an inactivated vaccine that requires two doses. Those who have history of allergies, are immune-compromised, pregnant, breastfeeding mother, have bleeding disorder, fever or any other serious health related issues are not advised to get Covaxin.
Early in January, the Indian government granted the Bharat Biotech vaccine emergency authorization even though Phase 3 clinical trials were yet to be completed.
All India Drug Action Network said then that it was “shocked” and “baffled” by the emergency approval of India’s homegrown vaccine. But the government insisted it will be safe and effective.
So far, only Pfizer has secured EUA for its COVID-19 vaccine from the FDA. An emergency use authorization will allow a new vaccine to be administered in the country.
British-Swedish firm AstraZeneca, Russian drugmaker Gamaleya and China’s Sinovac have pending application before the FDA.
The government’s target is to inoculate 50 to 70 million Filipinos against COVID-19 in 2021 but this hangs on the availability of vaccines, which had been mostly procured by wealthy nations. — with a report from Agence France-Presse