FDA says 'thorough' not slow in approving COVID-19 vaccines emergency use

Gillan Ropero, ABS-CBN News

Posted at Jan 25 2021 08:52 AM

ABS-CBN News/file

MANILA - The Food and Drug Administration (FDA) is being "thorough" in approving emergency use applications of COVID-19 vaccines, its chief said Monday against claims it was moving too slowly.

The FDA has so far given only one emergency use authorization (EUA) to US drugmaker Pfizer.

The usual process takes 6 months up to a year, said FDA director general Eric Domingo.

"This is the fastest we've ever done anything. I think an emergency use authorization within 21 days is very fast, very efficient. It might take longer for applicants that do not have an EUA from stringent regulatory authorities and we want to take a look at the data v closely. It’s not being slow, it’s being thorough," he told ANC's Matters of Fact.

"They think everything depends on the FDA EUA but really it’s the supply chain and procurement process. We gave the EUA to Pfizer 2 weeks ago but it’s not yet here, it’s not the FDA EUA the reason we don’t have the vaccine yet. It’s a worldwide shortage."

The FDA might come out with a decision for the emergency use application of AstraZeneca this week, while it was still asking for some clinical data from Russia's Gamaleya, Domingo said.

Sinovac has submitted its clinical data last Thursday and India's Bharat has yet to give its phase 3 interim results to FDA, he added.

Meantime, there is no evidence that interchanging brands of vaccines for the first and second doses is effective, Domingo said.

"Every study that has been done uses one vaccine for the first dose and the same vaccine for the second dose," he said.

"There’s no evidence to show you can interchange or u can make a substitution for the vaccine, especially if the vehicle’s different, if the technology is different. You have to finish the doses."

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