FDA: AstraZeneca COVID-19 vaccine no need for trials in PH if tests abroad include Asians

Kristine Sabillo, ABS-CBN News

Posted at Dec 15 2020 11:16 PM

MANILA — The Food and Drug Administration on Tuesday said it shouldn’t be a problem that AstraZeneca is no longer holding COVID-19 vaccine clinical trials in the Philippines as long as its tests abroad involve Asians.

“Basta mapakita sa datos na nasubok din nila na sya sa mga kalahi natin- mga Asians and similar racial ethnicity as Filipinos then maaari naman po natin tanggapin ang kanilang data on safety and efficacy at maaari natin itong i-evaluate,” FDA Director General Eric Domingo said during a Laging Handa briefing.

(As long as they show data that they were able to test the vaccine on Asians or those with similar racial ethnicity as Filipinos then we can accept their data on safety and efficacy and we can evaluate.)

The FDA revealed last week that AstraZeneca, which is among the frontrunners of the COVID-19 vaccine race, withdrew its application to run a clinical trial in the Philippines after it completed its data through tests elsewhere.

Now, there are 4 vaccine developers left applying for clinical trials in the Philippines — Sinovac, Clover Biopharmaceuticals, Janssen, and Gamaleya Institute. 

The DOH previously said that it would be better if vaccine developers can run their clinical trials in the country since it would ensure that the vaccine is safe for Filipinos.

Before AstraZeneca’s withdrawal, the company already sealed a supply deal with the Philippine private sector.

PFIZER 

Among the vaccine frontrunners, only Pfizer has gotten emergency use approval in the United States and the United Kingdom.

The DOH previously said the company is already working on a confidentiality agreement with them.

Asked if the EUA from the US and UK would mean Pfizer could be the first vaccine in the country, Domingo said it’s still not sure.

“Siguro malamang mauuna syang makakuha ng EUA dito dahil kumpleto na sila ng dokumento dahil nasubmit na nila sa 2 regulatory agencies. And these are trusted and reliable regulatory agencies, yung sa US FDA at saka sa UK,” he said. “Pero iyon pong the matter of producing and supplying and allocating supply for the Philippines, iyon ang hindi natin masabi kung sino unang makakapagsupply nung yun pong bakuna na maaaring ipadala dito sa atin.”

(Perhaps it will be the first to get an EUA here since it has already completed its documents by submitting to 2 regulatory agencies. And these are trusted and reliable regulatory agencies — the US FDA and the UK…But on the matter of producing and supplying and allocating supply for the Philippines, we can’t say who will be the first to supply vaccines that can be sent here.)

Because many countries are aiming to get COVID-19 vaccines early, the Philippines is also trying to convince vaccine developers like Sinovac to send their vaccines by March next year.

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