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MANILA – The Food and Drug Administration (FDA) said on Saturday that Russia’s Gamaleya Institute completed its documents for the Sputnik V emergency use application in the Philippines and is now pending evaluation.
“They completed their requirements just yesterday, so it is pending evaluation and I will be part of that team. And based on the initial evaluation, they have already met the requirements of the Good Manufacturing Practice (GMP) certificate, ”said Dr. Oscar Gutiérrez Jr., FDA’s deputy director general of field operations in an interview on“ Dateline Philippines ”from ANC.
The Sputnik V vaccine is 91.6 percent effective against COVID-19, according to results published in The Lancet medical journal.
Earlier this week, the FDA said that a team will travel to Russia to conduct the GMP inspection.
“Following Monday’s review, the team will assess whether an inspection will be necessary before granting the EUA. We are only concerned with the vaccine. The focus is not on the GMP inspection but on the GMP proof that the manufacturer is capable of producing the vaccine in a consistent manner based on the approved specification that will be granted by the FDA, ”Gutiérrez clarified.
The FDA, he said, did not conduct a GMP inspection at the facilities of other vaccine manufacturers that have already received the USA.
“My initial assessment of the document is that they presented the issued GMP certificate, the GMP certificate from Turkey, and it will be sufficient as proof of GMP evidence,” Gutiérrez said.
He added that it will take the FDA 21 days to grant an EUA once all the documents are submitted.
“If the FDA grants the EUA, anyone can get the vaccine for as long as it is indicated for that person,” the FDA official said.
Foreign Secretary Teodoro Locsin Jr. said he was “turning every stone” to bring the Sputnik V vaccine to the country.
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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Food and Drug Administration, FDA, Gamaleya Institute, Sputnik V, COVID-19 vaccine, Sputnik V USA, ANC Top, ANC Exclusives, Dateline Philippines
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