Indian pharmaceutical firm Bharat Biotech created a Covid19 vaccine called Covaxin. As of late June, it was approved for Philippine use by the Food and Drug Administration (FDA). The clearance came after all emergency use authorization (EUA) requirements were submitted by Bharat, according to FDA director general Eric Domingo at a public briefing.
FDA gave Bharat’s initial January application a “conditional EUA” in April due to incomplete documents. Now, they have provided a certificate on passing inspections for Good Manufacturing Practice. Covaxin can now be sent to the Philippines for use, bringing the number of brands with EUA in the Philippines up to eight. (The others include AstraZeneca, Gamaleya-Sputnik V, Janssen, Moderna, Pfizer-BioNTech, Sinopharm, and Sinovac.)
At the same press briefing, Domingo was asked about Moderna and Sinovac jabs for minors. In response, he said neither company is prepared for their Covid19 vaccines’ indication to be expanded for a younger age range. Both companies are not looking to apply yet, likely since they are still compiling clinical trial data.
The manufacturers of Moderna and Sinovac will apply for EUA expansion when they are ready, Domingo added.