FDA: No one applied for COVID-19 vaccine trial yet

The Food and Drug Administration (FDA) said Friday they had not received any application for the COVID-19 trial in the Philippines yet.

“Wala pa po kaming na-receive na clinical trial application,” Dr. Jesusa Cirunay, director of FDA’s Center for Drug Regulation and Research, said in an online forum.

Cirnuay explained that under a standard-setting, it would take around 45 to 60 days for an application to be approved, but the time frame would be shortened for COVID-19 trials.

“It will be lesser for COVID, provided that the documents submitted are complete. Kailangan namin ang kumpletong dokumento matanggap because we cannot process it kung kulang-kulang ang dokumento,” Cirunay said.

She added the approval of the last stage of the Phase 4 trial would generally take 70 to 90 more working days. But it could be expedited given the urgency for a against COVID-19.

Presidential spokesperson Harry Roque earlier said in a televised briefing that could be injected with Sputnik V, as early as May 1, 2021, given that Food and Drug Administration (FDA) in the Philippines approved the vaccine.

According to Roque, the expert panel will evaluate the results of phase 1 and 2 clinical trials this September. He added the Philippines and Russia would run simultaneous phase 3 clinical trials.

Also read: COVID-19 vaccine trial volunteer to be compensated – DOST

Sputnik V COVID-19 vaccine trial

Local experts noted that the results of the Russian vaccine’s Phase 1 and Phase 2 trials were not yet published.

“Hindi pa po natin nakikita ang Phase 1 and Phase 2 results of this. It has to be published in the scientific world so that everybody can look into its safety, tolerability as well as the effectiveness,” Dr. Josefina Carlos, an infectious disease specialist and a vaccine clinical trialist, said.

“The results are not published yet in the scientific world, if I may say,” she added.

Dr. Jacinto Mantaring, chair of the Single Joint Research Ethics Board, also said they have not any official document yet for Sputnik V’s COVID-19 vaccine trial in the Philippines.

“Wala pa kaming natatanggap na any form of application for the clinical trial pero ang masasabi ko, kasama kasi sa review ng isang trial ang literature,” he said.

“We will not allow any trial if there is no preliminary proof of efficacy and safety… Ang layunin ng Phase 1 and Phase 2 is more of safety. Pag nakitang safe doon pa lang gagawa ng Phase 3,” he added.