Indian firm Bharat seeks EUA from FDA for COVID-19 vaccine

Bharat BioTech has applied for an emergency use authorization (EUA) for its COVID-19 vaccine Covaxin, the Food and Drug Administration (FDA) said.

“They submitted an application this morning,” FDA Director General Eric Domingo told GMA News Online in a text message.

“Pre-evaluation [of their application] is going on,” Domingo added.

Only Pfizer-BioNTech COVID-19 vaccine has secured EUA from the Food and Drug Administration so far after the FDA found it 95% and 92% effective on study population and among all races, respectively.

A vaccine should be issued an EUA for it to be administered in the country.

Other COVID-19 vaccines with pending EUA application before the FDA include that of AstraZeneca, Gamaleya and Sinovac.

Vaccine czar Carlito Galvez, Jr. earlier said the Philippine government will be securing 148 million doses of COVID-19 vaccines from seven vaccine makers so far including Pfizer-BioNTech, Sinovac, Astrazeneca, Novovax, Johnson and Johnson, Gamaleya and Bharat BioTech.

The country’s COVID-19 vaccine rollout is expected to start next month.

The Philippines has registered 505,939 COVID-19 so far. Of this number, 466,993 recovered while 10,042 died.

The number of active COVID-19 cases is at 28,904. -NB, GMA News