nina Analou De Vera at Jun Fabon
Binigyan na ng Food and Drug Administration (FDA) ng emergency use authorization (EUA) ang coronavirus disease 2019 (COVID-19) vaccine ng Russian drugmaker na Gamaleya Research Institute.
“Today, we would like to announce that after a rigorous and thorough review by the regulatory and medical experts of the currently available published and unpublished data, the FDA is granting emergency use authorization to the Sputnik V Gam-Cov-Vac COVID-19 vaccine manufactured by Gamaleya National Center of Epidemiology and Microbiology,” pahayag ni FDA Director General Rolando Enrique Domingo sa isang pulong balitaan.
Ayon kay Domingo, may rason upang paniwalaang mabisa ang
Bagong halal na mayor ng Rizal, Cagayan 21-anyos pa lang; vice mayor, nanay niya
Sputnik V vaccine laban sa COVID-19 batay na rin sa kabuuan ng ebidensyang hawak ng mga ito sa ngayon, kabilang na ang mga datos mula sa “well-known controlled trials.”
Ipinaliwanag ni Domingo, lumabas aniya sa interim data ng isinasagawang Phase 3 trials ng nasabing bakuna na aabot sa 91.6 porsiyento ang overall efficacy nito laban sa COVID-19 at ang efficacy rate nito ay tumutugma sa lahat ng age groups mula 18-anyos at pataas.
“The adverse events reported were mostly mild and transient similar to common vaccine reactions. No specific safety concerns were identified,” aniya. Sa nasabing bakuna, dalawang dosis ang kailangan na may tatlong linggong pagitan.
“The known and potential benefits of the Gamaleya Sputnik V vaccine, when used to prevent COVID-19, outweigh the known and potential risks,” paliwanag nito.
Paglilinaw ng opisyal, ang EUA ay hindi marketing authorization.
“We have not issued any Certificate of Product Registration for any COVID-19 vaccine, so no COVID-19 vaccine can be sold in the market commercially. Hence, this EUA cannot be used as an authorization to market the vaccine commercially,” pahayag ni Domingo.
