Domingo: FDA Team Flying To Russia To Review Gamaleya’s Sputnik V Vaccine Application

The Philippines’ FDA team will fly to Russia to review Gamaleya’s Sputnik V COVID-19 vaccine application, according to Domingo.

FDA Director-General Eric Domingo said that a team of inspectors from the Philippines’ Food and Drug Administration (FDA) will fly to Russia in order to review Gamaleya’s Sputnik V COVID-19 vaccine application.

FDA Sputnik V

In a report on CNN Philippines, a team from the Philippines’ Food and Drug Administration (FDA) will fly to Russia from March 15 to March 18 in order to finalize its assessment on Gamaleya Research Institute, which was applying for the emergency use authorization (EUA) of its Sputnik V COVID-19 vaccine.

On Thursday, FDA Director-General Eric Domingo said a team of inspectors will fly to the Gamaleya Research Institute manufacturing plant because it had not yet submitted a Certificate of Good Manufacturing Practice (GMP) two months since the company applied for the Emergency Use Authorization (EUA).

Russia’s Gamaleya Research Institute invited the Food and Drug Administration to inspect their factory instead of submitting the requirement personally.

Domingo also said that the Gamaleya Research Institute’s local representative would pay the application fee for the Good Manufacturing Practice inspection, saying that this was part of the usual standard operating procedures.

CNN Philippines reported that Domingo said in a text message that they explained that every country that had inspected their plant and gave them an Emergency Use Authorization didn’t issue the Certificate of Good Manufacturing Practice.

Ang ine-explain kasi nila is that every country na nag-license sa kanila, kapag pumupunta doon iniisinspect sila, binibigyan sila ng EUA pero hindi sila inissuehan ng certificate of GMP,” Domingo said.

READ ALSO | Domingo: FDA Yet To Start Evaluation Of Sinopharm’s Application For EUA

Domingo also said that the Food and Drug Administration aimed to release the result of Gamaleya Research Institute’s EUA application before the end of the month.

According to Domingo, the team they’re sending to Russia were trained, adding that they’re tasked to give their feedback if something needed to be fixed or explain what measures needed to be done so that their findings can be addressed.

Russia’s Gamaleya Research Institute had submitted its EUA application in January 2021, the third vaccine manufacturer to apply for emergency use in the Philippines. However, other companies that applied much later had already received their authorization.

Previously, Russia’s Gamaleya Research Institute told the Philippine government that it could supply 50 to 100 million COVID-19 vaccine doses to the country. Gamaleya Research Institute’s Sputnik V had so far been administered to over two million people worldwide.

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