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PH vaccine experts still studying Gamaleya's request to extend interval between Sputnik V doses - FDA

Published Jun 25, 2021 02:48 pm

A health worker shows Sputnik V coronavirus vaccines at a vaccination hub in Taguig City on May 4, 2021. (Ali Vicoy/MANILA BULLETIN)
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The country's Vaccine Experts Panel (VEP) is currently studying the request of Russia's Gamaleya Research Institute to amend its COVID-19 vaccine's emergency use authorization (EUA) to have a longer interval between the required two doses, the Food and Drug Administration (FDA) said.

"Pinag-aaralan ngayon ng mga vaccine experts natin (Our vaccine experts are now studying it)," said FDA Director-General Rolando Enrique Domingo during a public press briefing on Friday, June 25.

During the Cabinet briefing last June 21, Domingo said that the Gamaleya Research Institute has sought to amend the Sputnik V's two dose interval, from the original of 21 days to three months.

Domingo said that the initial feedback of the local experts on the matter is positive.

"Kahapon nakausap ko po yung vaccine experts natin. Ang sabi nila, wala naman kasing problem pag nade-delay ang second dose pero may hinihingi lang silang datos para ma-fix kung kailan talaga yung maximum period ng pagbigay ng second dose (Yesterday I talked to our vaccine experts. They said, there is no problem when the second dose is delayed but they are just asking for data to fix when really is the maximum period for giving the second dose)," the FDA chief said.

"Kapag nakasagot ang Gamaleya at mabigay yung data nila ay madedesiyunan naman agad iyon (Once Gamaleya answered and provided their data, it will be decided immediately)," he added.

There is nothing wrong if there is a long interval between the two doses of COVID-19 vaccines, a member of the VEP said in a separate briefing on Friday.

“Kung ma-delay man siya, as long as the delay is not after six months or after a year (If it is delayed, as long as the delay is not after six months or after a year),” said VEP member Dr. Rontgene Solante.

“In fact ang nakikita natin ngayon, if you look at AstraZeneca, yung 12 weeks na interval nila, ang ganda pa din. Mas tumaas ang efficacy niya to 80 percent instead of just 67 percent--four weeks interval (In fact, if you look at AstraZeneca, their 12 -week interval is still good. Its efficacy increased to 80 percent instead of just 67 percent for the four weeks interval),” he said.

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