SPUTNIK V VACCINE

FDA appeals to Russian Embassy for help in expediting Gamaleya’s EUA application

Food and Drug Administration director general Eric Domingo appealed Thursday to the Russian Embassy to help in expediting the application of Gamaleya Research Institute for emergency use authorization for its Sputnik V vaccine.

"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," Domingo said during a House hearing.

"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," he added.

At present, vaccine experts from the Department of Science and Technology are studying the safety and efficacy of Sputnik V to Filipinos, according to Domingo.

"They were just doing some more ano, fine tuning lang doon sa safety and efficacy particularly doon sa vaccine because this is a viral vector vaccine..." Domingo said.

Presidential spokesman Harry Roque has said 10 to 15 million doses of COVID-19 vaccine from Gamaleya are expected to arrive in April.

Roque had said the country will have enough vaccines for at least 70 million Filipinos for this year. — RSJ, GMA News