Emergency use approval for Pfizer’s COVID-19 vaccine may be out ‘within a month’ — FDA

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Metro Manila (CNN Philippines, December 28)— The emergency use authorization or EUA for Pfizer’s coronavirus vaccine in the Philippines may be issued “within a month,” the Food and Drug Administration said Monday.

“Basically I would think two to three weeks for evaluation and within a month if everything is acceptable and in order then maybe we can release an Emergency Use Authorization,” FDA director general Eric Domingo said in an interview with CNN Philippines.

Domingo noted that the review process in granting local EUA to Pfizer’s vaccine may be shorter and easier following previous approvals in other countries, as the FDA also looks at the assessment of international regulatory bodies.

“We do have a reliance mechanism wherein there are some very stringent regulatory authorities that we recognize and that we acknowledge, and we accept their decisions and their assessments, and take a look at them,” Domingo told The Source separately, citing the US Food and Drug Administration and the European Medicines Agency, among others.

“Once a vaccine has an EUA from one of these countries, it’s a lot easier for them to apply here. And the process is a little shorter, it’s more abbreviated, because we know that it’s also been looked upon by a reliable country,” he noted.

Domingo said the FDA received Pfizer’s application on December 23, adding that documents are being sorted out and will be forwarded to its panel of experts and officers. Malacañang earlier said it will take 21 days for the FDA to evaluate and approve the EUA, but Domingo stressed it may be shorter or longer depending on the review.

Countries including the US and the United Kingdom have earlier granted EUA for Pfizer’s vaccine, with some residents already receiving their first dose.

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The US-based drug manufacturer earlier revealed that the final analysis of the Phase 3 trial of its coronavirus vaccine shows it was 95% effective in preventing infections, and caused no serious safety concerns.

The Philippine FDA, for its part, said it will still have to check the “proven stability” of the product, especially since it would be transported from other countries. Domingo added the agency will also review its safety and efficacy profile on different racial groups.

“We also have to check some nuances, we just want to see if it has been tried on a population similar to ours, like Asians and Pacific islanders,” he noted.

CNN Philippines' Alyssa Rola and Carolyn Bonquin contributed to this report.