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FDA cancels Russia inspection trip after Gamaleya submits documents for EUA
By JULIA MARI ORNEDO, GMA NewsThe Food and Drug Administration (FDA) on Wednesday said it has canceled its inspection trip to Russia after the Gamaleya Institute submitted the documents required to apply for emergency use authorization (EUA) of its coronavirus vaccine Sputnik V.
A team from the FDA was supposed to fly to Russia to inspect Gamaleya’s manufacturing plant for Sputnik V.
“The inspection trip to Russia did not push through because last Friday the applicant submitted the required documents and those are being reviewed,” FDA chief Eric Domingo told GMA News Online. "Inspection trip [is] canceled."
Gamaleya filed an EUA application in January after withdrawing
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Vaccine czar Secretary Carlito Galvez Jr. earlier said the Philippines would place an order for 5 to 10 million Sputnik V doses once it receives an EUA.
The FDA has so far approved the Pfizer-BioNTech, AstraZeneca, and Sinovac vaccines for emergency use.
The COVID-19 vaccination program has covered 240,297 health workers as of Tuesday.—AOL, GMA News