The Philippines’ FDA canceled its inspection trip to Russia due to this reason.
The Philippines’ Food and Drug Administration (FDA) was supposed to fly to Russia to inspect Gamaleya’s manufacturing plant for Sputnik V but had canceled its inspection trip due to this reason.
FDA Director-General Eric Domingo on Wednesday told GMA News Online that it had canceled its inspection trip to Russia after Russia’s Gamaleya Research Institute had submitted the documents required to apply for emergency use authorization (EUA) of its COVID-19 vaccine 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. Inspection trip [is] canceled,” Domingo said.
READ ALSO | Domingo: FDA Team Flying To Russia To Review Gamaleya’s Sputnik V Vaccine Application
Gamaleya had filed an EUA application last January after withdrawing its bid to hold a human clinical trial in the Philippines.
Earlier, vaccine czar Secretary Carlito Galvez Jr. said that the Philippines would place an order for 5 million to 10 million Sputnik V COVID-19 vaccine doses once it received an emergency use authorization.
The Food and Drug Administration had so far approved the Pfizer-BioNTech, AstraZeneca-Oxford, and Sinovac COVID-19 vaccines for emergency use in the Philippines.
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