MANILA, Philippines (Updated 11:21 a.m.) — The Philippines has approved the coronavirus vaccine developed by Russia’s Gamaleya Research Institute for emergency use, the country’s Food and Drug Administration said Friday.
Sputnik V is the fourth coronavirus jab to get emergency use authorization in the country, which is battling a resurgence of COVID-19 infections that is feared to overwhelm the health system anew.
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“It is decided that all conditions for an EUA are present and the benefits of using the vaccine outweigh the potential risk,” FDA Director General Eric Domingo said in a briefing.
The authorization clears Sputnik V for use on individuals aged 18 years and older. “No specific safety concerns” were identified, Domingo said.
Sputnik V vaccine has been criticized for its speedy development. But a peer-reviewed late-stage trial results published in The Lancet medical journal showed the vaccine has a 91.6% efficacy rate against the virus and is completely protective against severe forms of COVID-19.
The EUA will be valid only within the duration of the declared public health emergency or upon the issuance of certificate of product registration.
The drug regulator earlier granted authorizations given to the vaccines developed by Pfizer-BioNTech, AstraZeneca and Sinovac Biotech. The Pfizer-BioNTech shot had the highest efficacy rate at 95%.
Vaccine czar Carlito Galvez Jr. said in an interview on ABS-CBN News Channel that the country may receive two million doses of Sputnik V from Russia once its obtains EUA from the FDA.
The government is eyeing to purchase 5 to 10 million doses of Sputnik V to add to the country’s supply of vaccines consisting of donated doses from Sinovax and the World Health Organization-led COVAX Facility.
After several delays, the country launched its vaccination campaign against COVID-19 on March 1. Given the limited supply, only frontline healthcare workers are being vaccinated at the moment. Uniformed personnel are also receiving Sinovac shots.
The Philippines has so far reported over 640,984 COVID-19 cases, including 12,887 deaths