AstraZeneca applies for COVID-19 vaccine emergency use in PH – FDA

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Metro Manila (CNN Philippines, January 6) - British drugmaker AstraZeneca has applied for emergency use authorization of its COVID-19 vaccines in the country, the Food and Drug Administration said on Wednesday.

FDA Director General Eric Domingo told CNN Philippines' Newsroom Ngayon that AstraZeneca is the second vaccine manufacturer to apply for EUA, following the US-based Pfizer last December.

“Dumating na rin ang application ng AstraZeneca for an EUA dito sa FDA," Domingo said. "Sa ngayon ay dina-download pa namin ang kanilang application para mapadala namin agad sa ating mga evaluators, experts, tsaka mga regulatory officers ng FDA."

[Translation: The FDA has already received the application of AstraZeneca for EUA. We are currently downloading their application so we can forward it to the evaluators, regulatory officers, experts, and our regulatory officers.]

The British vaccine manufacturer approved last December the request of the private sector for the sale of more COVID-19 vaccines to the country, on top of the 2.6 million doses secured earlier.

Domingo said the evaluation of AstraZeneca's application might be faster given that the United Kingdom has already approved the use of its vaccines.

"Ang maganda sa AstraZeneca meron na rin siyang EUA from the United Kingdom," he said. "Kapag nakita natin yung evaluation report from the UK, it's going to be helpful...magiging mas mabilis usually ang ating review sa ganito."

[Translation: AstraZeneca has already secured an EUA from the United Kingdom...Once we see the UK's evaluation report on it, it's going to be helpful...our review will be faster.]

However, Domingo noted that a vaccine for emergency use is not meant for commercial distribution, but only for government use.

"Kapag nagbigay po tayo ng emergency use authorization, hindi po ito maaring ibenta, hindi ito mabibili sa mga botika, o darating sa clinic at pwede tayo magpa-bakuna privately. Ito po ay maaring bilhin ng pamahalaan at gamitin sa vaccination program," he said.

[Translation: When we issue an emergency use authorization, the vaccines cannot be distributed to the market, they cannot be purchased from pharmacies, or can be availed in clinics and have a shot privately. They can only be purchased by the government and use for the vaccination program.]

Domingo added that China's Sinovac and Russia's Gamaleya Institute have also inquired about the process and requirements for securing EUA of their vaccines.

The FDA also said on Wednesday that the decision on Pfizer's emergency use application will be out on Jan. 14.