FDA explains why COVID-19 vax procurement must go through national gov't under EUA

The Food and Drug Administration (FDA) on Monday said the procurement of all COVID-19 vaccines must still go through the national government because these products would only be issued with emergency use authorization (EUA) for local distribution in the country.

"Ang vaccine, the usual route, it takes about seven years to procure a vaccine and they can only apply for a certificate of product registration or marketing authorization once that these three trials are completed," FDA director general Eric Domingo said in a Senate hearing.

"Ang Emergency Use Authorization po, the FDA allows the use of a product that is still under development. Nasa kalagitnaan pa lang po ng Phase 3 trial ito kaya lang mayroon pong kondisyon, mayroon tayong pandemic," he added.

He underscored that the COVID-19 vaccines which will be given EUA is not yet an "approved product."

"Pag ganoon po, ang mga kompanya hindi rin po sila nagte-take ng responsibility para sa kanilang produkto. Ang national government po will take responsibility for using a product that is still under development," Domingo said.

Nonetheless, he said the Department of Health can still designate local government units and private sector to be part of the national vaccination program.

"Lahat po ng bansa na ginagamit ngayon ang mga bakuna, national government po ang nagko-control ng vaccination dahil ito po lahat ay under EUA pa lang at wala pang bakunang pwedeng magpa-full registration sa buong mundo," Domingo said.

On the other hand, Senate President Pro Tempore Ralph Recto and Minority Leader Franklin Drilon asserted that something must be done to remove this "stumbling block" that prevents the private sector from directly buying from vaccine manufacturers.—AOL, GMA News