FDA cancels inspection trip to Russia after Gamaleya submits EUA documents

Published March 17, 2021, 5:26 PM

by Analou de Vera

The Food and Drug Administration (FDA) has called off its inspection trip to Russia after the Gamaleya Research Institute submitted the necessary documents needed for the evaluation of its emergency use authorization (EUA) application for the COVID-19 vaccine, Sputnik V.

Food and Drug Administration (FDA)

“The inspection trip to Russia did not push through because last Friday, the applicant submitted the required documents and those are being reviewed,” said FDA-Director General Rolando Enrique Domingo in a text message on Wednesday, March 17.

A team from the FDA was supposed to visit the Russian firm to inspect the “Good Manufacturing Practice” of Gamaleya, which is a requirement for an EUA.

Domingo, in an interview last March 11, noted that the inspection requirement was vital in Gamaleya’s EUA bid. “Iyan ang major deficiency nila, may iba pa pero minor nalang (That is their major deficiency, there are others but only minor ones),” he said.

Vaccine Czar Carlito Galvez Jr on Tuesday, March 16, said the government was planning to place an order of at least five to 10 million doses of Sputnik V vaccine once it already secured an EUA with the Philippine FDA.

In a statement last December 14, the Gamaleya Research Institute said that its vaccine has an efficacy of 91.4 percent against COVID-19

The Philippine FDA has so far approved the EUA application of American drugmaker Pfizer, British pharmaceutical firm AstraZeneca, and China’s Sinovac Biotech.