(Eagle News) – Russia’s anti-COVID-19 vaccine Sputnik V has been given emergency use authorization (EUA) by the Food and Drug Administration (FDA), the agency’s director general said.
FDA Director General Undersecretary Eric Domingo said that they issued the EUA to Sputnik V manufactured by Russia’s Gamaleya Research Institute after a “rigorous and thorough review.”
Sputnik V even has a higher efficacy rate against COVID-19 at 91.6 percent, which is higher than the 63.09% against symptomatic SARS-CoV-2 infection for AstraZeneca, and over 50 percent for Sinovac’s Coronavac.
“The interim data from the ongoing phase three trials as published in Lancet show that the vaccine has overall efficacy of 91.6 percent in preventing Covid-19. And the efficacy rate is consistent among all age groups, 18 and older,” Domingo said
Sputnik V will be administered in two doses of 0.5 ml of intramuscular injections. The second dose will be given 21 days or three weeks after the
first injection.
Domingo said that the reactions to the Sputnik V vaccines were “mostly mild and transient, similar to common vaccine reactions.”
According to the Lancet journal published on Feb. 5 this year, Sputnik V vaccine “appears safe and effective.”
“Vaccine efficacy, based on the numbers of confirmed COVID-19 cases from 21 days after the first dose of vaccine, is reported as 91·6% (95% CI 85·6–95·2), and the suggested lessening of disease severity after one dose is particularly encouraging for current dose-sparing strategies,” it said.
The Lancet journal is a weekly peer-reviewed general medical journal, and is often cited in medical circles.
With the EUA from the FDA, the Sputnik V vaccines can now be used in the country’s vaccine rollout against COVID-19.
(Eagle News Service)
