FDA says finalizing emergency authorization of AstraZeneca's COVID-19 vaccine

Aleta Nieva Nishimori, ABS-CBN News

Posted at Jan 27 2021 02:25 PM | Updated as of Jan 27 2021 02:36 PM

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

MANILA - The Food and Drug Administration (FDA) is finalizing AstraZeneca's application for emergency use authorization (EUA) of its COVID-19 vaccine in the Philippines, with a "very favorable" evaluation forwarded by experts, an official said Wednesday. 

FDA Director General Eric Domingo said their experts and regulatory panel have submitted their recommendations on the vaccine.
“Aayusin ko lamang po at titingnan ang ating mga tinatawag na kondisyon para makita natin at ma-finalize na. Pero very favorable naman po ang tingin ko dito sa ating mga evaluation po ng mga experts natin,” said Domingo.

(I will take a look at it and see if they complied with our conditions before finalizing it. But I think the evaluation of our experts is very favorable.)

The Philippines has secured 17 million doses of AstraZeneca's coronavirus vaccines with the help of the private sector and local government units.

The first initial dosages is expected to arrive in the country by mid-year.

The issuance of an EUA will allow its use in the Philippines under an expedited review period. 

Aside from AstraZeneca, the country was also able to secure 30 million vaccines from the Serum Institute of India and 25 million doses from China’s Sinovac.

Watch more in iWantTFC

In an interview on TeleRadyo, Domingo said Sinovac and Russia’s Sputnik V have already submitted data for clinical trials and that their respective COVID-19 vaccines are currently undergoing experts’ evaluation.
“Wala nang pending application for clinical trials sa FDA. 'Yung tatlong nag-apply, na-approve na natin 'yan—yung sa Janssen o company ng Johnson & Johnson, 'yung Clover Pharmaceuticals at saka 'yung Sinovac. Maari na silang mag-umpisa ng kanilang clinical trials,” he said. 

(There are no other pending application for clinical trials in the FDA. The other three that applied were already approved—Janssen or the company of Johnson & Johnson, the Clover Pharmaceutical and Sinovac. They can now start their clinical trials.)

The FDA stressed that even if other countries are now using COVID-19 vaccines, it is important that they go through clinical trials especially is they are still under emergency use.

He explained that data from clinical trials of these vaccines are not yet complete and that they would have to recruit new participants.

“Usually, 'yung clinical trials natin nagkakaroon ng sanga-sanga 'yan. Halimbawa, susubukan sa matatandang-matatanda, tapos ngayon magsta-start na rin naman sa buong mundo clinical trials sa younger population kasi as of now, wala pang bakuna for children. Tuloy-tuloy ang clinical trials na ito to check for other indications and uses of the vaccines,” sabi niya.

(Usually, our clinical trials have branches. For example, it would be used on the elderly, then the global clinical trials for the younger population would start because as of now, there is still no vaccine for children. Clinical trials continue to check for other indications and uses of the vaccines.)
Clinical trials can last from one to two years, he added.