FDA just waiting for Moderna EUA application

Kristine Sabillo, ABS-CBN News

The Food and Drug Administration has yet to receive an emergency use authorization (EUA) application from COVID-19 vaccine developer Moderna but it is already reviewing published studies to expedite the process.

This, as Philippine Ambassador to the US Jose Manuel Romualdez said Moderna will be delivering almost 200,000 doses of its COVID-19 vaccines to the country by June 15.

“Hindi pa rin sila nag-aapply (They have not applied yet),” FDA Director General Eric Domingo said during a virtual briefing. 

“Mukhang meron lang silang konti pang inaayos sa side ng kung sino ang representative nila dito sa Pilipinas para magappply. Hopefully masettle na po iyon para makapagfile na sila ng official application dito,” he added.

(They might just be arranging for a representative who will apply for them in the Philippines. Hopefully they are able to settle that so they can file their official application here.)

An EUA would allow a vaccine under development to be used for the government vaccination program. For vaccines that are already approved by Stringent Regulatory Authorities abroad, the processing of an EUA takes 21 days.

Domingo said it is helpful that Moderna, unlike other vaccine developers, already have published data in peer-reviewed journals on the COVID-19 vaccine’s safety and efficacy.

“So ito po ay binabasa na rin at rinereview ng ating mga eksperto para pagdating ng time na sila ay mag-aapply na eh at least naumpisahan na natin ang [pag-review ng impormasyon],” he said.

(This is already being read and reviewed by our experts so that when the time comes and they apply then at least we already started reviewing.)

While the government aims to vaccinate up to 70 million people by the end of the year to reach herd immunity, only 1.6 million doses have been administered as of April 22. The government said this is due to the limited supply of vaccines. 

Besides Moderna vaccines expected in June, there are also more than 100,000 vaccines coming from Pfizer in May. Half a million doses will also come from Russia’s Gamaleya Institute and there will be 1 million more vaccines from China’s Sinovac in April.

https://news.abs-cbn.com/news/04/23/21/fda-just-waiting-for-moderna-eua-application