Domingo: FDA Decision On Pfizer Vaccine Application Out Before End Of January 2021

The FDA will decide on Pfizer vaccine application before the end of January 2021, according to Domingo

FDA Director-General Eric Domingo on Thursday said that the Food and Drug Administration will decide on an emergency use authorization (EUA) for the Pfizer COVID-19 vaccine before the end of January 2021.

Pfizer vaccine
Photo source: Reuters

According to Domingo, while the evaluation of new vaccines usually took 3-6 months, the coronavirus pandemic and the Executive Order issued by President Rodrigo Duterte allowing the Food and Drug Administration to issue an emergency use authorization would speed up the process without compromising safety.

Domingo also said that Pfizer — whose COVID-19 vaccine had been proven 95 percent effective after human clinical trials — submitted its emergency use authorization (EUA) application to the Food and Drug Administration last December 24, 2020.

The Pfizer COVID-19 vaccine needed a -70°C to -90°C storage, meaning an ultra-cold freezer which the Philippine government didn’t have so far.

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When asked if the results of the Food and Drug Administration’s evaluation of Pfizer COVID-19 vaccine could come sooner considering that Pfizer had already been used in mass vaccination in the US, UK, Singapore, Canada, among others, Domingo said that it wasn’t that simple.

For Domingo, it can’t be faster than 2-3 weeks and he had to give his experts time to look at it considering that Pfizer developed the vaccine outside the Philippines and didn’t conduct human clinical trials in the Philippines.

We have to see disaggregated data on their studies and their subjects who were at least Asians. These are the things not previously presented in the US and Europe,” Domingo added.

READ ALSO: China OKs Sinopharm COVID-19 Vaccine For General Public Use

According to Domingo, the emergency use authorization wasn’t a one-page certification as it involved a lot of documents stating the conditions on how EUA would be used.

Only Pfizer had submitted an application for emergency use authorization to FDA Philippines thus far.

Presidential spokesman Harry Roque Jr. assured the public that the mass inoculation program of the Philippine government was on track of starting during the Q1 of 2021.

However, some members of the Presidential Security Group (PSG) were already vaccinated with unregistered COVID-19 vaccines back in September and October 2020.

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