By Fernan Angeles
PRESIDENT Duterte has directed the Food and Drug Administration (FDA) to fast-track the approval of the China-made vaccines Sinovac and Sinopharm, FDA director-general Rolando Domingo said.
Responding to Duterte, Domingo said that they are still waiting for the results of the clinical trial of China-made COVID-19 vaccines, so the FDA could start evaluating them.
Duterte instructed Domingo to fast-track the approval of the China-produced vaccines, particularly Sinovac and Sinopharm, so the government can begin inoculating Filipinos, particularly the soldiers.
“‘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. ‘Yun lang, magiging stringent kasi wala pa silang pinaggalingang US FDA (US Food and Drug Administration) counterpart,” Domingo said.
Domingo explained that 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 however asked for Duterte’s patience over the meticulous measures they are following insofar as approving the vaccines. “Bagong-bago pa ’yung mga bakuna . . . Masyadong bago pa kasi ang platform at teknolohiya.”