FDA: No one has applied for COVID-19 vaccine clinical trials

Published August 21, 2020, 2:35 PM

by Minka Klaudia Tiangco

As the world races to develop a vaccine for the coronavirus disease-2019 (COVID-19), the Food and Drug Administration (FDA) on Friday (Aug. 21) has yet to receive any application for clinical trials in the Philippines, said FDA-Center for Drug Regulation and Research director Dr. Jesusa Cirunay in an online forum.

(PIXABAY / MANILA BULLETIN)

Under normal circumstances, it takes 45 to 60 days to approve an application for a clinical trial, while the approval of the fourth and last stage of the clinical trials takes 70 to 90 days.

However, Cirunay said these processes would be expedited for a COVID-19 vaccine.

The Inter-agency Task Force for the Management of Emerging Infectious Diseases (IATF) on Thursday (Aug. 20) said applications for clinical trials must first be submitted to the Vaccine Expert Panel, reviewed by designated ethics boards, and submitted to the Food and Drug Administration for review and approval for the conduct of clinical trials.

Earlier, President Duterte accepted Russia’s offer to conduct and fund the third phase of its COVID-19 vaccine clinical trials in the Philippines, saying that he will be the first to take a shot to ensure its safety.

Malacañang said Duterte can only get vaccinated as early as May 1, 2021.

‘Sputnik V’ trial results

Meanwhile, some vaccine experts said the results of the first and second phase of the clinical trials of “Sputnik V,” the Russian COVID-19 vaccine, have not been released despite it already being in the third phase.

Dr. Josefina Carlos, a pediatric infectious disease specialist and a clinical trialist, said the first and second phases of the vaccine clinical trials would look into its safety, efficacy, and optimal number of doses.

“We have to look into this first. We don’t know. I haven’t read the results. The results are not published in the scientific world, if I may say,” she said.

Dr. Jacinto Blas Mantaring, chairman of the Department of Health (DOH) Single Joint Research Ethics Board, said they will not allow “Sputnik V” to go through with the third phase of the clinical trials until they have seen its preliminary results.

“We will not allow any trial if there is no preliminary proof of efficacy and safety,” he said. “We need to look at the scientific and ethical considerations. We need to look at the safety reports, there should be a continuing review, to ensure the safety of research participants.”

“Hindi porke’t may pandemya ay ikokompromiso namin ang proseso, ang pag-review ay high quality (Just because there is a pandemic does not mean that we will compromise the process, reviewing is of high quality),” he added.

Presidential Spokesman Harry Roque recently said that an expert panel in the country will review the results of the first and second phases of the clinical trials of “Sputnik V” in September.

The third phase of the Russian vaccine clinical trials by the Gamaleya Research Institute of Epidemiology and Microbiology will be held simultaneously in the Philippines and Russia from October 2020 to March 2021.

The vaccine is expected to be registered with the FDA by April 2021.

 
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