A team from the Philippine Food and Drug Administration (FDA) will visit the Gamaleya Research Institute in Russia this month, which has applied for an emergency use authorization (EUA) for its coronavirus disease (COVID-19) vaccine, Sputnik V.
FDA Director-General Rolando Enrique Domingo said that the team will be composed of two to three members and are expected to fly to Russia in the “third week of March.”
“The inspectors will inspect the manufacturing facility to check for Good Manufacturing Practice. The applicant pays for the inspection,” said Domingo in a text message on Thursday, March 11.
When asked if the inspection on Gamaleya’s manufacturing facility is vital in its EUA bid, Domingo said: “Iyan ang major deficiency nila, may iba pa pero minor nalang (That is their major deficiency, there are others but only minor ones).”
FDA has yet to give an exact timeframe when it will issue a decision on the EUA application of Gamaleya. “(It) depends on the findings during the inspection,” said Domingo.
The Russian pharmaceutical firm submitted its EUA application for its COVID-19 vaccine in January.
Meanwhile, Domingo said that the FDA is not yet starting to evaluate the EUA application of China’s pharmaceutical firm Sinopharm.
The FDA chief said that they are not yet considering the application of Sinopharm as “official.”
“Hindi pa. Hindi pa sila sumagot since binigyan sila ng list of requirements and hindi pa sila nagbayad ng application fee (Not yet. They have not responded since they were given the list of requirements and they have not paid the application fee),” said Domingo.
So far, only three pharmaceutical companies have secured an EUA from the FDA: the American drug-maker Pfizer, British firm AstraZeneca, and China’s Sinovac Biotech.