FDA asks for Russian embassy help to expedite EUA for Sputnik-V vaccine
FILE PHOTO: Empty vials of the second dose of the Sputnik V (Gam-COVID-Vac) vaccine are pictured at the San Martin hospital, in La Plata, on the outskirts of Buenos Aires, Argentina January 21, 2021. REUTERS/Agustin Marcarian/File Photo
MANILA, Philippines — The Food and Drug Administration (FDA) is asking for the help of the Russian embassy in the country so the agency can expedite the granting of an emergency use authorization (EUA) for the Sputnik-V Covid-19 vaccine of the Gamaleya Institute.
During the online meeting of the House committee on people’s participation on Thursday, FDA Director-General Eric Domingo said Gamaleya’s EUA application for Sputnik-V remains pending in the Philippines. The said vaccine already has a EUA issued from countries such as Russia and Argentina.
Domingo said the Russian embassy can provide an authorization letter that will assure the FDA that Gamaleya’s local representatives in the Philippines can sign the documents needed for the EUA application which would, in effect, speed up the application process.
“Number 1, because we need some documents of course to be attested to by the manufacturer and we know the manufacturer is in Russia and it’s very difficult for some documents to go there and get here,” Domingo said.
“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 faster,” he added.
Moreover, Domingo said Gamaleya also needs to submit a good manufacturing practice (GMP) certification which is required to “assure the consistency of the quality of the product.”
“We have a team here in the Philippines that is ready and capable of doing a GMP inspection… the Russian government is also very willing to help us coordinate so that we can send our inspection team there to inspect the factory,” Domingo said.
“Once the company has applied for that GMP inspection, we can schedule that, we have a team ready for that,” he added.
Currently, only Pfizer and AstraZeneca have so far secured EUAs from the FDA.
/MUF
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