FDA: Sputnik V completed documents for emergency use application in PH


Posted at Mar 13 2021 04:11 PM | Updated as of Mar 14 2021 12:57 PM

MANILA (UPDATE) —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 was now up for evaluation.

The Sputnik V vaccine has been found 91.6 percent effective against COVID-19, based on results published in medical journal The Lancet.

The FDA will evaluate if it would need to send a team to Russia to inspect good manufacturing practice, said Dr. Oscar Gutierrez Jr., the FDA’s deputy director general for field operations.

“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 requirements,” he told ANC's “Dateline Philippines.”

“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 on 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."

The FDA did not conduct a GMP inspection at the facilities of other vaccine manufacturers already granted EUA, Gutierrez said.

He added that it would 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 51 countries, including Mexico, Iraq, Myanmar, and Sri Lanka, among others, its manufacturer said.

The Philippines plans to buy 20 million doses of Sputnik V.


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