FDA aims to decide on Pfizer vaccine emergency use by Jan. 14, AstraZeneca to apply soon

Kristine Sabillo, ABS-CBN News

Posted at Jan 06 2021 09:30 AM | Updated as of Jan 06 2021 06:51 PM

Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Pfizer logo in this illustration taken October 31, 2020. Dado Ruvic, Reuters/Illustration/File​

MANILA (UPDATE) — The Food and Drug Administration of the Philippines on Wednesday said it might release its decision on the emergency use application (EUA) of Pfizer’s COVID-19 vaccine by January 14.

“Kahapon, nagbigay ng konting katanungan yung ating mga eksperto na pinadala natin sa sa Pfizer. At binigyan ko sila ng 48 hours to reply and give the information requested by our panel. Pagkatapos nun, ibabalik sa akin ng January 10. And a few days after that, makakagawa na tayo ng desisyon sa kanilang aplikasyon,” FDA Director General Eric Domingo said during a Laging Handa briefing.

(Yesterday, our experts raised a few questions that were sent to Pfizer. We gave them 48 hours to reply and give the information requested by our panel. After that, it will be returned to us on January 10. And a few days after that, we can make a decision on their application.)

Domingo’s slide presentation showing the timeline for Pfizer indicated January 14 as the date estimated for the FDA’s decision on Pfizer’s EUA application.

On Wednesday afternoon, Domingo told media that Europe-based multinational firm AstraZeneca has finally applied for EUA.

Besides having a tripartite supply deal with the private sector and the Philippine government, AstraZeneca is also in talks with local government units looking to procure their own vaccine supply.

Domingo's pronouncements come as nations across the world began inoculating their population to quash fresh infections.

In an interview earlier in the day on ANC, Domingo, referring to the vaccine developed by Pfizer and its German partner BioNTech, said, "We are not taking long while waiting. And believe me, we are making this as quick as possible. And I'm quite sure, we'll be out with the authorization within a week. That is quite short if you compare to other countries."

Pfizer and BioNTech’s candidate vaccine were among the first to declare its efficacy rate against COVID-19. With an efficacy rate of 95 percent, their vaccine was soon approved for emergency use by the United States and the United Kingdom.

Its application for EUA in the Philippines was made on Dec. 23, and evaluation started on Dec. 28, Domingo said.

Unfortunately, vaccine czar Sec. Carlito Galvez said during the same forum that the supply from Pfizer might not arrive immediately. 

“Nakikita natin ang Pfizer ang most in demand na brand. Most likely magiging available po ito ng Q3 and Q4. With the challenges that they had hindi makakayanan ang early deployment,” he said, adding that countries experiencing a spike in cases are those that are set to receive Pfizer’s next batch of vaccines.

(We are seeing that Pfizer is the most in demand brand. Most likely it will be available in the 3rd or 4th quarter. With the challenges that they had, they can’t do early deployment.)

Domingo revealed that China's Sinovac and Russia's Gamaleya Institute had already asked for requirements for a possible emergency use of their vaccines in the country.

China's Sinopharm and US' Moderna have yet to contact the FDA, he added.

Should the Philippines grant its first emergency use for a COVID-19 vaccine, Domingo said health authorities were already preparing for the procurement of the vaccine.

"Everything's being prepared. Everything's being ready for the rollout but securing the actual vaccines would probably take some more time even after the EUA," he said.

Galvez said the government was in advance talks with Novavax, AstraZeneca, Pfizer, Johnson & Johnson, Sinovac and Gamaleya and that deals might be clinched by the end of the month.

Since the pandemic began, the Philippines has tallied nearly 480,000 coronavirus infections, of which over 9,300 have died from the disease.

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- with reports from Davinci Maru and Jamaine Punzalan, ABS-CBN News