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COVID-19 vaccine just around the corner? No one applied for trials yet, says FDA exec


The Food and Drug Administration (FDA) on Friday said it has yet to receive any application from COVID-19 vaccine developers to even start a trial in the Philippines.

"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.

She explained that under a normal course, it would take about 45 to 60 days to approve an application for a clinical trial but it would be facilitated faster for COVID-19 vaccines.

"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.

The approval of the Phase 4 trial or the last stage, on the other hand, will generally take about 70 to 90 more working days. This part can be expedited for the COVID-19 vaccine, she added.

President Rodrigo Duterte, during his fifth State of the Nation Address, claimed that a vaccine against COVID-19 is "just around the corner."

He even expressed willingness to get the first shot of the Russian-developed Sputnik V vaccine.

Sputnik V trial results

While many are pinning their hopes on this Russian vaccine, the local experts underscored that the results of its Phases 1 and 2 trials were not even published yet.

"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 also said the Single Joint Research Ethics Board, which he chairs, has not received any official document yet for Sputnik V's clinical 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.

Sputnik V will likely be available for commercial use in the Philippines by April 2021, according to Philippine Council for Health Research executive director Dr. Jaime Montoya as Russia's FDA is seen to approve it this coming January.

For now, Russia plans enlisting 10,000 individuals in four countries —UAE, Saudi Arabia, Brazil, and the Philippines—for the Phase 3 of the clinical trials for Sputnik V and around 1,000 Filipinos are expected to join.

Malacañang said President Rodrigo Duterte could be injected with the Russian-made vaccine as early as May 2021— RSJ, GMA News