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FDA grants EUA for Sputnik V

Republika

Russian research institute Gamelaya’s Sputnik V Covid19 vaccine has been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA), making it the fourth vaccine to be used in the country.


FDA Director General Eric Domingo announced on Mar. 19 that Sputnik V had undergone thorough review, indicated benefits that outweigh risk, and met all criteria required to be granted EUA.


Domingo further stated that the vaccine’s 91.6% efficacy rating based on interim data from the on-going stage 3 clinical trials, is uniform enough among all age groups.


The vaccine however, will only be administered to individuals 18 years of age and above. Furthermore, although no notable side effects of concern have been recorded, monitoring after immunization is still necessary.


With the EUA granted, the country may receive 2 million doses by April, with an additional 5 to 10 million more doses currently being negotiated, according to vaccine czar Carlito Galvez, Jr.


As of Mar. 22, over 336,000 doses of Covid19 vaccines have been administered in the country.


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