Vaccine firms yet to apply for emergency use in PH, says FDA

ABS-CBN News

Posted at Dec 16 2020 10:13 AM | Updated as of Dec 16 2020 10:31 AM

Vaccine firms yet to apply for emergency use in PH, says FDA 1
A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in this illustration taken Oct. 30, 2020. Dado Ruvic, Reuters/File

MANILA - Vaccine firms have yet to apply for emergency use in the Philippines, the Food and Drug Authority said Wednesday as it urged Chinese drugmakers to register their COVID-19 vaccine in order for these to be distributed in 3 months.

The FDA published its guidelines for emergency use authorization (EAU) on Monday, said executive director Eric Domingo.

"So far we have not received any formal application yet...It takes time to prepare. In the Philippines, I’ll only accept the application if they already have an EUA in their home country," he told ANC's Headstart.

"I guess it’s really also the timing of the companies being able to supply that is why they're not yet applying for EUAs. Maybe they're not yet ready to supply even if we do give them that authorization, maybe production is not enough to supply here immediately."

Domingo, meantime, said China's Sinovac or Sinopharm should now apply for an EUA in the country if they plan to roll out their vaccines by March.

The Philippines has no information yet on Sinopharm's phase 3 clinical trials while Sinovac is expected to get their clinical trial phase 3 interim report by end of the month, Domingo added.

"Remember, if Sinovac or Sinopharm apply, these have EUAs only in China but not in WHO (World Health Organization)-qualified regulators," he said.

"We’re going to have to take a close look at this and it will take a little longer than for example a product that’s already been approved by US, Japan, Singapore which are known to have very stringent regulatory agencies."

Domingo said the FDA would look at 2 criteria in approving the vaccine: 1) safety and efficacy, and 2) quality and stability.

"We have to see the clinical trial results, we have to check the safety profile and see any if there were any adverse effects, and we have to see the efficacy, how it protects the person if injected," he said.

"For a vaccine to be useful, this is pegged at 60 to 70 percent efficacy minimum requirement. The higher it is, the better."

The vaccine firm or the government who will be using the vaccine may apply for an EUA, Domingo said as the Duterte administration attempt to secure supplies from various drugmakers.

"I guess we can make early negotiations but as I said di naman siya mapapasok dito hanggang di makukumpleto ang data on safety and efficacy," he said.

(The vaccines cannot enter the country until we have complete data on its safety and efficacy.)

"Mahirap din kung biglang darating ang data tapos mamadaliin natin. We have to very careful with this because these are new products."

(It will be difficult if data suddenly arrives and we rush it.)

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