FDA Appeals To Russian Embassy To Help In Expediting Gamaleya Research Institute’s EUA Application In PH

The FDA appealed to Russian Embassy to help in expediting Gamaleya Research Institute’s EUA application in the Philippines.

The Food and Drug Administration (FDA) on Thursday appealed to Russian Embassy to help in expediting Gamaleya Research Institute’s EUA application for its Sputnik V COVID-19 vaccine in the Philippines.

FDA Gamaleya
Photo source: GMA News Online

In a report on GMA News Online, Food and Drug Administration Director-General Eric Domingo appealed to the Russian Embassy to assist in expediting the application of Russia’s Gamaleya Research Institute for emergency use authorization (EUA) for its Sputnik V COVID-19 vaccine.

During a House hearing, Domingo said that they needed some documents to be attested to by the vaccine manufacturer and they knew that the vaccine manufacturer was in Russia.

There were four items that we need lang, to make things faster… number one because we need some documents to be attested to by the manufacturer and we know that the manufacturer is in Russia and it’s very difficult for some documents to go there and get here. So, maybe if the embassy can give some authorization, a letter that will allow FDA, assure FDA, that their local representative here is authorized by the manufacturer, Gamaleya, to sign documents for them,” Domingo said.

READ ALSO | Palace: Sinovac Prefers To Wait For EUA Approval Before Delivering COVID-19 Vaccines To PH

At present, Domingo said that vaccine experts from the Department of Science and Technology (DOST) were studying the efficacy and safety of Gamaleya’s Sputnik V to Filipinos.

Meanwhile, Presidential Spokesperson Harry Roque had said that 10 million to 15 million COVID-19 vaccine doses from Russia’s Gamaleya were expected to arrive in the Philippines in April 2021.

According to Roque, the Philippines would have enough COVID-19 vaccines for at least 70 million Filipinos for this year.

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