MANILA – The Food and Drug Administration (FDA) has allowed the emergency use of COVID-19 vaccines made by Johnson & Johnson and India's Bharat Biotech, it said on Tuesday.
Both vaccines can be administered to people aged 18 and above in the Philippines, the agency chief, Rolando Enrique Domingo, said in a mobile text message.
The benefits of Bharat and J&J's vaccines "outweigh" their risk, Domingo said in a public briefing.
Bharat Biotech needs to submit one more document to drug regulators before it can import its COVID-19 shots, he said.
As for Johnson & Johnson's Janssen vaccine, US experts are investigating 7 reports of blood clots out of 7 million inoculated people, said Domingo.
The FDA urged the Department of Health to come up with "very clear guidelines" before Janssen is rolled out so that those inoculated would know what effects to watch out for and where to seek medical help, he said.
Janssen is cleared for emergency use in 40 countries, and is included in the emergency listing of the World Health Organization, he said.
Video courtesy of PTV
J&J is conducting late-stage clinical trials for its COVID-19 vaccine in the Philippines.
The single-shot coronavirus vaccines developed by J&J's unit Janssen and Bharat Biotech's Covaxin are the fifth and sixth to receive emergency use approval in the Philippines, which is battling one of the worst outbreaks in Asia.
The Philippines earlier cleared the COVID-19 shots of Pfizer, AstraZeneca, Gamaleya Institute, and Sinovac Biotech.
Worldwide, Hungary granted the most number of emergency use authorizations at 8, said Domingo.
There is no longer any pending application for EUA with the Philippine FDA, he said.
Chinese firm Sinopharm Biotech has yet to submit requirements for its EUA application, Domingo said.
– With reports from Jamaine Punzalan, ABS-CBN News; Reuters