Philippine experts to sign confidentiality agreement before clinical trials for Sputnik V can start

Philippine health and vaccine experts will sign a confidentiality data agreement with their Russian counterparts before Phase 3 of the clinical trials of Sputnik V can proceed in the country, a Philippine Council for Health Research official said Thursday.

Dr. Jaime Montoya, PCHR executive director, said they met with Sputnik V’s Russian manufacturer Gamaleya and other Russian investors Wednesday in connection with the holding of Phase 3 of the clinical trials in the Philippines.

“Ipinakita po nila iyong Phase 1, Phase 2, pati pre-clinical trials, at mukhang okay naman po, sufficient naman ang antibody level, walang side effects kundi kaunting lagnat pero kailangan pa rin namin makita ang ibang detalye,” Montoya said in an interview with Dobol B sa News TV.

“Kaya magsa-sign po tayo ng confidentiality data agreement para matignan ang detalye [ng Phase 1 at Phase 2 clinical trials ng Sputnik V]. Mga next week, okay na ‘yun (confidentiality data agreement),” he added.

“Kapag nakita natin iyong detalye ng Phase 1 at 2, magsa-submit tayo sa ating FDA (Food and Drug Administration) kasi kailangan ng approval ng FDA para sa Phase 3 ng clinical trial,” he further said.

Montoya then said that Russia's FDA approval is different from the Putin-led Russian government approval of Sputnik V since the latter is only a certification for emergency use given the COVID-19 pandemic.

He said such certification means that the vaccine can be used on their health care workers and high-risk sector of the population.

He added Russia is eyeing to enlist 10,000 individuals in four countries for the Phase 3 of the clinical trials for Sputnik V.

“Iyong protocol kasi kung paano gagawin iyong [Phase 3 ng] clinical trial, gagawin ng Russian vaccine developer. Iyong ibang bansa na kasali, UAE, Saudi Arabia, Brazil…isa lang tayo sa apat, at ang estimate nila sa atin na maisasali ay 1,000,” Montoya pointed out.

“Kailangan po ng informed consent,” he added.

Both Health Secretary Francisco Duque III and Undersecretary Maria Rosario Vergeire, however, have said that Sputnik V, which has not been cleared by the World Health Organization, needs further study.

The Philippines has 143,749 COVID-19 cases so far. Of this number, 68,997 recovered while 2,404 died. There are 72,348 active COVID-19 cases to date.—AOL, GMA News