Palace: ‘Almost automatic’ for Pfizer’s COVID-19 vaccine to get authorization in PH

MANILA, Philippines — Since American drugmaker Pfizer’s COVID-19 vaccine was already approved in the U.S., Malacañang said Sunday it’s “almost automatic” that it will receive an Emergency Use Authorization (EUA) in the Philippines.

“Tatapatin ko kayo. Dahil ang Pfizer ay aprubado sa Amerika, halos automatic na yan,” presidential spokesperson Harry Roque said in an interview over Teleradyo when asked of the chances for Pfizer’s COVID-19 vaccine to secure an EUA.

(I will be frank with you. Since Pfizer is already approved in America, it’s almost automatic that the company will be authorized.)

Pfizer filed for an EUA before the Philippines’ Food and Drug Administration (FDA) on Dec. 23, Roque earlier said, citing information from FDA Director-General Eric Domingo.

The American drugmaker secured an EUA for its COVID-19 vaccine, which was shown to have 95% efficacy in preventing the virus, from the U.S. FDA on Dec. 12.

“May sinasabi lang si Dr. Domingo na kinakailangan lang, siguraduhin na epektibo rin yan at ligtas sa mga Asians, mga Malay race kasi karamihan sa ginamit sa clinical trial ay mga puti. Pero sabi niya, may mga limang porsyento naman dyan na Asians din at titignan din yung datos para sa Asian,” Roque said.

(Dr. Domingo was saying that there is a need to ensure that the vaccine is also effective and safe for Asians, for those who are Malay race because most of the people who joined its clinical trials are white. But he said that five percent of them were Asians so we’re looking at that data.)

“Pero ang policy po kasi ng FDA, kapag mature regulatory agency ang nag-apruba, e malaki ang tiwala ang binibigay ng Philippine FDA sa ganyang approval,” he went on.

(But the policy of the FDA is if a mature regulatory agency approved the vaccine, the Philippine FDA gives its big trust to that kind of approval.)

Securing an EUA from the Philippines’ FDA will allow a new vaccine to be administered in the country.

JPV