FDA to decide on first COVID-19 vaccine trial application in 1-2 weeks

Kristine Sabillo, ABS-CBN News

Posted at Oct 30 2020 05:44 PM

MANILA — The Food and Drug Administration (FDA) might release its decision on the application of COVID-19 vaccine developer Sinovac Biotech Ltd. in a few weeks, an official said Friday.

The Chinese company is the first to have its application for a clinical trial in the Philippines reviewed by the FDA.

“The most advanced is still undergoing evaluation,” FDA Director General Eric Domingo said referring to Sinovac, which is represented by its manufacturing company IP Biotech and is already undergoing an ethics review and FDA’s regulatory review.

“And we hope to have a decision on that within 1 to 2 weeks para malaman kung pasado siya o hindi (to see if they will pass or not). We can give an approval or denial,” Domingo added.

Sinovac is among the several frontrunners in the race for a COVID-19 vaccine.

Domingo said that even if the government would prioritize the World Health Organization’s Solidarity Trial, the Sinovac trial, once it is approved, may push through first.

The Solidarity Trial, which will involve testing several different COVID-19 vaccines in a number of countries, is slated to start in December.

Besides Sinovac, the Philippines is also evaluating two more applications for clinical trials. One is from Johnson & Johnson’s Janssen Pharmaceutical.

“There’s a #3 na company that has shown interest in doing clinical trials here in the Philippines. And they are now undergoing pre-screening with the vaccine expert panel,” he said, referring to Clover Biopharmaceuticals.

Both Janssen and Clover Biopharmaceuticals are undergoing assessment by the vaccine expert panel of the Philippines.

Meanwhile, Domingo said they have not yet formally considered the application of Russia’s Gamaleya Institute because it has yet to respond to the expert panel’s request for more data.

In a tweet, Foreign Affairs Secretary Teddy Locsin Jr. said he would be meeting the European pharmaceutical company AstraZeneca with the FDA on Friday.

Domingo said the company already asked information on how to apply.

“They asked the vaccine expert panel about conducting clinical trials here and they were given the information,” he said of AstraZeneca. “If they decide to make an application the government is ready to evaluate. But so far wala pa silang sina-submit (so far they have not submitted anything).”

Domingo said the public can regularly check updates on COVID-19 vaccines through their tracker on the FDA website.

He also reiterated that there is no vaccine approved yet by the Philippines or any other country. This as netizens reported online posts claiming that a COVID-19 vaccine was already being sold in the country.

Domingo also explained that vaccines that would eventually be donated to the Philippines won’t get marketing authorization and should undergo evaluation as well.

“It should be compliant with good quality standards,” he said. “And of course the DOH will never get any donation from unreliable sources.”