MANILA, Philippines — The Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for the Sputnik V COVID-19 vaccine developed by Russia’s Gamaleya Institute.
“After a rigorous and thorough review, the FDA is granting EUA to the Sputnik V COVID-19 vaccine,” FDA Director General Eric Domingo announced on Friday.
“It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known and potential risks,” he added.
Based on interim data from ongoing Stage 3 clinical trials, the vaccine is 91.6% effective in preventing COVID-19.
Domingo said the Sputnik V vaccine can only be used on individuals aged 18 years and older.
The efficacy rate of the vaccine, he added, is “consistent” and “quite uniform” among all age groups.
Adverse effects from the vaccine recorded are “mostly mild and transient and similar to common vaccine reactions” and no specific safety concerns were identified.
Domingo, however, said close surveillance and monitoring is still needed after immunization.
This is the fourth vaccine that secured an EUA in the country.
The Food and Drug Administration central office
Vaccine czar Carlito Galvez Jr. earlier said the Philippines may receive two million doses of the Sputnik V vaccine this April once it secures an EUA.
He added that the government is in talks with Gamaleya to secure five to 10 million doses of the vaccine.