FDA: AstraZeneca’s withdrawal from trials won’t affect approval of vaccine


Posted at Dec 11 2020 10:30 PM

Food and Drug Administration (FDA) director-general Dr. Eric Domingo on Friday said UK-based pharmaceutical firm AstraZeneca's withdrawal from conducting clinical trials linked to its coronavirus vaccine should not affect the regulatory approval of the shot. 

Domingo said in an interview on Teleradyo that AstraZeneca could apply for an emergency use authorization (EUA) to make its vaccine available in the country.

"Kung may EUA sila from a stringent regulatory authority tulad ng USFDA o WHO pre-qualification, mabilis lang 'yan. Kaya nating ilabas dito ng 3 to 4 weeks," said Domingo.

(If they can secure an EUA from a stringent regulatory authority like the USFDA or through WHO pre-qualification, it can be readily available here in the Philippines in 3 to 4 weeks.)

Domingo added that vaccines being developed by other pharmaceutical companies are taking the same route.

"Marami namang may ibang bakuna d'yan na maaaring mauna sa kanilang makakuha ng EUA tulad ng Pfizer, 'yung Moderna... Of course, nandyan din 'yung vaccines galing China yung Sinovac, Sinopharm. May mga EUA na 'yan sa China, pati yung Sputnik mayroon nang UEA sa Russia," he said.

(There are companies with EUAs for their vaccines like Pfizer, Moderna . . . Of course, there are Sinovac, Sinopharm. They have EUAs from China, and Sputnik which has EUA from Russia.)

AstraZeneca withdrew its application to conduct clinical trials in the Philippines after it deemed its data complete to support its efficacy. 

The withdrawal of AstraZeneca has left the FDA with 2 applications. The agency was also expecting another application to be filed by Johnson and Johnson’s Janssen.

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