3 Covid-19 vaccines under pre-screening for clinical trials: FDA

Both Janssen and Clover’s vaccines, Domingo said, are currently being evaluated by the Vaccine Expert Panel (VEP) while Sinovac’s is currently undergoing an ethics review and evaluation by the FDA. (File photo: @thisisengineering/Unsplash)

MANILA – At least three potential vaccines for the coronavirus disease 2019 (Covid-19) are under pre-screening but none authorized yet to administer clinical trials in the country, an official of the Food and Drug Administration (FDA) said on Friday.

In a virtual presser, FDA Director General, Undersecretary Eric Domingo said these vaccines are sponsored by Netherlands-based Janssen Vaccines & Prevention (Janssen), China’s Sinovac Biotech (Sinovac), and most recently, Clover Biopharmaceuticals (Clover) from Australia.

Both Janssen and Clover’s vaccines, Domingo said, are currently being evaluated by the Vaccine Expert Panel (VEP) while Sinovac’s is currently undergoing an ethics review and evaluation by the FDA.

“Yung most advanced [Sinovac] is still undergoing evaluation and we hope to have a decision on that within one to two weeks para malaman kung pasado siya o hindi (The most advanced, which is Sinovac’s, is still under evaluation and we hope to have a decision within one to two weeks to know whether it would be approved),” Domingo said.

He noted that Russia’s Gamaleya Institute and its Sputnik V vaccine would also soon be evaluated by the VEP.

“Yung Gamaleya yata meron pang mga tanong at hinihinging information yung VEP (For Gamaleya, I think there are still questions and some information that is being asked by the VEP) and when they submit that, then the formal evaluation of the vaccine expert panel will start,” Domingo said.

Once approved for clinical trial, he said these companies will be allowed to test their vaccines on thousands of human subjects in the Philippines, or up to 40,000 individuals from several different countries.

“We regulate this to protect human rights to make sure that the safety of human subjects is assured. And dapat syempre yung clinical data, yung integrity nun hindi make-question–sigurado tayo (And of course the clinical data, its integrity should not be questionable—we must be sure of it),” Domingo said.

No Covid-19 vaccines approved for sale

Following reports that some Chinese “clinical trial vaccines” for Covid-19 are being sold for up to PHP50,000 per dose, he said the FDA has conducted an investigation and found no vaccines in the reported facility.

“Kahit nagki-clinical trial ang mga produkto sa Pilipinas or sa ibang bansa (Even if these products are undergoing a clinical trial here in the Philippines or in other countries) and it’s not a registered product, they cannot be promoted as safe and effective and definitely they cannot be sold,” Domingo said.

He noted that even medical products that have been donated to the country and approved for use by the FDA and the Department of Health (DOH) would need to undergo a separate evaluation and approval process before these can be sold in the country.

“We just want to remind everybody that there are still no registered Covid-19 vaccines in the Philippines. Kung meron po kayong nakikita na naga-advertise, nagbebenta, at sinasabi na meron na (If you find someone advertising, selling, or saying that it’s available), please report them directly to us,” Domingo said.

Earlier, Presidential Spokesperson Harry Roque warned the public of Covid-19 vaccines that are being sold but not approved by the FDA.

He noted that those found attempting to sell these vaccines through chain messages or other marketing methods will be punished under the law.