Food and Drug Administration (FDA) Director-General Eric Domingo on Thursday said the Russian embassy could provide an authorization letter to help expedite the granting of an emergency use authorization (EUA) for Russia’s Sputnik-V vaccine for the coronavirus disease 2019 (Covid-19).
In an online meeting of the House committee on people’s participation, Domingo said the authorization letter must assure the FDA that Gamaleya Institute’s local representatives in the country can sign the documents needed for their EUA application.
Domingo cited that the EUA application process requires certain documents “to be attested to by the manufacturer who is in Russia,” making it difficult for the documents to be sent there for verification and sent back to the country.
“So maybe if the [Russian] 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 these documents for them, that will make it [the application process] faster,” he said.
While Sputnik-V Covid-19 vaccine has been granted EUA from other countries like Argentina and Russia, its EUA application in the Philippines is still pending.
Domingo added the Gamaleya Institute must submit a good manufacturing practice (GMP) certification “assuring the consistency of the quality of their product.”
The government would schedule a GMP inspection of their factory once the manufacturer has applied for it.
“We have a team here in the Philippines that is ready and capable of doing a GMP inspection,” Domingo said. “The Russian government is also very willing to help us coordinate so that we can send our inspection team there to inspect the factory.”
The FDA has granted EUA to AstraZeneca’s and Pfizer-BioNTech’s Covid-19 vaccines last month.
Some 117,000 doses of Pfizer-BioNTech’s Covid-19 vaccine are expected to arrive in the country in one tranche this month.
Sinovac Biotech’s bid for EUA of its Covid-19 vaccine in the country is still being processed by the FDA. SOVEREIGNPH