FDA team to inspect Covid vaccine factory in Russia

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A team from the Philippine Food and Drug Administration (FDA) will visiting Gamaleya Institute’s manufacturing facility in Russia next week for the possible issuance of an emergency use authorization (EUA) for the Sputnik V vaccine in the country.

FDA Director-General Eric Domingo on Wednesday also confirmed an earlier report that the EUA may be granted to Sputnik V within the next two weeks.

“Two weeks is best-case scenario. Might extend if not all findings are compliant,” he said.

Domingo said “a few documents” are still pending from Gamaleya but did not disclose what those were.

The Russian Embassy in Manila, meanwhile, said it continues to engage Philippine authorities to complete the necessary requirements for the EUA.

Earlier, Foreign Affairs Secretary Teodoro Locsin, Jr. shared that the Philippines may get up to 20 million doses of the Russian-made vaccine

“[I]n two weeks there’s the EUA for the Russian vaccine which could amount to another 20 million doses of the only Lancet peer-reviewed vaccine on the planet. Working on that,” he tweeted on Tuesday.

Sputnik V is the world’s first registered vaccine, with 91.6-percent efficacy against the coronavirus disease 2019 (Covid-19) as validated by internationally peer-reviewed data published in the medical journal The Lancet.

This figure is based on the analysis of data on 19,866 volunteers, who received both the first and second doses of the vaccine or placebo at the final control point of 78 confirmed Covid-19 cases, according to Sputnik V’s website.

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