MANILA—The Food and Drug Administration (FDA) on Saturday said Russia’s Gamaleya Institute has completed its documents for Sputnik V’s emergency use application in the Philippines and it is now up for evaluation.
“They completed their requirements only yesterday so it is up for evaluation and I will be part of that team. And based on the initial evaluation, they have already satisfied the certificate of GMP (Good Manufacturing Practice) requirements,†said Dr. Oscar Gutierrez Jr., the FDA’s deputy director general for field operations said in an interview on ANC’s “Dateline Philippines.â€
The Sputnik V vaccine is 91.6 percent effective against COVID-19, based on results published in the medical journal the Lancet.
Earlier this week the FDA said a team will fly to Russia to conduct the GMP inspection.Â
“Upon review on Monday, the team will evaluate if an inspection will be needed before we grant the EUA. We are only concerned about the vaccine. The focus is not on the GMP inspection but n the proof of GMP that the manufacturer is able to produce the vaccine consistently based on the approved specification that will be granted by the FDA,†Gutierrez clarified.
The FDA, he said, did not conduct a GMP inspection at the facilities of other vaccine manufacturers already granted the EUA.
“My initial evaluation of the document is they submitted GMP certificate issued — the Turkey GMP certificate— and it will suffice as a proof of GMP evidence,†Gutierrez said.
He added that it will take the FDA 21 days to grant an EUA once all the documents are submitted.
“If the EUA is granted by the FDA, anybody can receive the vaccine for as long as it is indicated for that person,†the FDA official said.
Foreign Affairs Secretary Teodoro Locsin Jr. said he was “turning every stone†to get to the country the Sputnik V vaccine.
Sputnik V has been approved in more than 15 countries. The Philippines planned to buy 20 million doses of Sputnik V.
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