The FDA approved the emergency use of the Sputnik V COVID-19 vaccine in the Philippines.
The Food and Drug Administration (FDA) recently approved the emergency use of Russia’s Sputnik V COVID-19 vaccine in the Philippines.
This, as the COVID-19 vaccine developed by Russia’s Gamaleya Research Institute was the fourth one to be granted emergency use authorization (EUA) in the country, next to Sinovac, AstraZeneca-Oxford, and Pfizer-BioNTech COVID-19 vaccines.
In a media briefing, FDA Director-General Eric Domingo on Friday announced that the Food and Drug Administration granted an emergency use authorization to the Sputnik V COVID-19 vaccine.
“After a rigorous and thorough review by regulatory and medical experts of the currently available published and unpublished data, the FDA is granting emergency use to the Sputnik V,” Domingo said.
According to Domingo, the Sputnik V COVID-19 vaccine can only be administered to clinically healthy individuals aged 18 years old and above.
Prior to this, Domingo said on Wednesday that the Food and Drug Administration was supposed to fly to Russia to inspect Gamaleya’s manufacturing plant for Sputnik V but had canceled its inspection trip after Gamaleya Research Institute had submitted the documents required to apply for EUA of its COVID-19 vaccine.
The Food and Drug Administration approved the emergency use of the Pfizer-BioNTech COVID-19 vaccine last January 14, 2021, AstraZeneca-Oxford COVID-19 vaccine last January 28, 2021, and Sinovac COVID-19 vaccine last February 22, 2021.
Meanwhile, the EUA application of Bharat Biotech for its COVID-19 vaccine called Covaxin was undergoing regulatory review.