Too slow? FDA says it's being 'thorough' in assessing EUA applications
MANILA, Philippines — The country's Food and Drug Administration is being “thorough” in assessing applications for emergency use of COVID-19 vaccines, its chief said Monday.
The FDA has been criticized that it was moving too slowly in approving COVID-19 jabs for emergency use in the Philippines.
But FDA Director General Eric Domingo said the agency's process “is not being slow but it’s being very thorough.”
“This is the fastest that we’ve done anything. I think the emergency use authorization within 21 days is very fast, very efficient. But it might take longer for applicants that do not have EUA from stringent regulatory authorities and we want to take a look at the data very closely,” Domingo said in an interview on ABS-CBN News Channel.
An EUA shortens the process of regulatory approval from the usual six months to as fast as 21 days.
The delays in the response of vaccine makers to the agency's queries also slow down the process, he added.
“They think that everything depends on the FDA EUA but really, it’s the supply chain and the procurement process. We gave EUA to Pfizer two weeks ago but it’s not yet here. It’s not the FDA EUA the reason we don’t have the vaccines yet,” Domingo said.
Authorities are scrambling to lock in supplies to inoculate at least 50 million Filipinos this year and help contain Southeast Asia’s second worst COVID-19 crisis.
AstraZeneca's application seen out this week
The FDA's decision on the application of AstraZeneca for the emergency use of its COVID-19 vaccine in the Philippines may be out this week.
“I hope we can come up with the decision this week,” FDA Director General Eric Domingo said.
“We have some questions for them and they finally sent in their replies on the evening of Friday. Our evaluators are gonna start looking through that again and hopefully come up with a decision soon,” he added.
The British-Swedish pharmaceutical submitted an application for emergency use of its vaccine developed with Oxford University to the Philippine FDA early this month. The AstraZeneca shot is found to be 70% effective on average, below the 95% reported for the COVID-19 jabs from American firms Pfizer/BioNTech and Moderna.
But AstraZeneca vaccines only need to be stored at around 2°C, which is the standard temperature that is within the existing cold chain system in the country.
The national government, local government units and private firms signed a deal with the drugmaker for a total of 17 million doses of its coronavirus vaccines.
So far, only Pfizer has secured EUA for its COVID-19 vaccine from the FDA.
What about other EUA applicants?
Russia drugmaker Gamaleya Research Institute, Indian firm Bharat Biotech and China’s Sinovac have pending EUA applications before the FDA.
Domingo said the regulatory agency is still requesting for additional information on Spuntik V, the vaccine developed by Gamaleya. Meanwhile, Sinovac submitted trial data last week.
“That’s at least another two weeks before we even finish evaluating that and even asking them more questions,” he said.
Bharat Biotech, which applied last week, has not yet submitted late-stage clinical trial results for its vaccine.
“We cannot start evaluating that until we get that information.”
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