Duterte wants China vaccine approval fast-tracked; PH FDA chief asks for patience

Dennis Gasgonia, ABS-CBN News

Posted at Dec 26 2020 11:29 PM

Duterte wants fast approval to provide vaccine for soldiers, police

Food and Drug Administration (FDA) director-general Rolando Domingo on Saturday said his office was only waiting for the results of the clinical trial of China-made COVID-19 vaccines, so the FDA could start evaluating the vaccines.

President Rodrigo Duterte instructed Domingo to fast-track the approval of the China-produced vaccines, particularly Sinovac and Sinopharm, so the government can begin inoculating Filipinos.

" 'Yun pong (Sinovac) clinical trial Phase 3 is wrapping up in December at lalabas na ang interim results nila . . . Once we have that, then we can have an evaluation," Domingo said.

" 'Yun lang, magiging stringent kasi wala pa silang pinaggalingang US FDA (US Food and Drug Administration) counterpart."

Domingo said medical products, such as vaccines, must hurdle stringent evaluation at par with the US FDA's or its UK counterpart so that the safety and efficacy of the vaccines are assured.

"Kapag galing na sa stringent regulatory agency, like US FDA or UK, minimal na lang ang additional requirements natin," Domingo said.

In the case of Sinopharm, Domingo said the drugmaker has already secured an emergency use authorization in China, which is good news, he said.

"That gives us some confidence na 'yung safety profile nila maganda. 'Yun lang po, dadaan pa rin sa expert panel po natin," he said.

Duterte said he favored SinoPharm, because he said it has already been used on Chinese soldiers.

The President said he wanted to secure COVID-19 vaccines for the military and police force.

"I take it as a declaration of its potency 'yung (Sinopharm) has passed the test results. They gave it to almost 1 million of their soldiers," said Duterte.

"I have to be frank to tell the truth. Marami nang nagpatusok at lahat up to now wala pa akong narining (na masama). Gusto kong mauna sila (soldiers) because I don't want a sickly Armed Forces, sickly police. 

"They have to be in good health all the time because they are responsible for the law and order of the country."

Domingo asked for patience approving the vaccines.

"Bagong-bago pa ’yung mga bakuna . . . Masyadong bago pa kasi ang platform at teknolohiya," he said.

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