FDA grants EUA to Sputnik V of Russia

The Gamaleya Research Institute’s coronavirus disease vaccine has been granted emergency use authorization (EUA) by the Food and Drug Administration, the agency confirmed Friday.

Filipinos can now be given the COVID-19 Sputnik V vaccine of Gamaleya once it arrives in the country. However, the vaccine could not be given to 17-year-olds and under, FDA director-general Eric Domingo said earlier.

“[Sputnik V, AstraZeneca] and also Pfizer [are safe for senior citizens]… is for 16 and above, AstraZeneca is for 18 and above and Sputnik is for 18 and above,” said Domingo at a press briefing.

“It is decided that all conditions for an EUA are present and the benefits of using the [Sputnik V] vaccine outweigh the potential risk.”

Sputnik V is the fourth COVID-19 vaccine that can be given to Filipinos now with a COVID-19 public health emergency. The other three are from -BioNTech, AstraZeneca, and Sinovac Biotech.

The Russian vaccine is said to have a 91.6% efficacy rate against COVID-19, something that will provide protection against severe forms of such disease. The government plans to get up to 10 million doses of Sputnik V.

Also read: Duque says vaccines ‘borrowed’ from provinces, not recalled

FDA grants EUA to Sputnik V of Russia

The vaccine would be administered in two doses and sold on international markets for less than $10 (around P500) but would be free for Russian citizens.

Meanwhile, it may be recalled that the FDA previously said that they could not recommend the use of Sinovac’s CoronaVac vaccine to those 60-years-old and older and healthcare workers exposed to COVID-19 due to the lower efficacy of the drug.

However, presidential spokesperson Harry Roque said Malacañang supported the recommendation of the National Task Force Against COVID-19 to provide the Sinovac vaccine to senior citizens.

“I think [vaccine czar Carlito Galvez Jr.] clarified that they are considering using it on older citizens once of course data is available to show that it is safe and effective in older citizens. I heard [Health Secretary Francisco Duque] reiterate this yesterday,” Domingo added.

“Of course, it will be to the manufacturer and the distributor of Sinovac to provide data.”