Russia’s Sputnik V COVID-19 vaccine gets emergency use authorization | Inquirer News

Russia’s Sputnik V COVID-19 vaccine gets emergency use authorization

By: - Reporter / @DYGalvezINQ
/ 10:23 AM March 19, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for the Sputnik V COVID-19 vaccine developed by Russia’s Gamaleya Institute.

“After a rigorous and thorough review, the FDA is granting EUA to the Sputnik V COVID-19 vaccine,” FDA Director General Eric Domingo announced on Friday.

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“It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known and potential risks,” he added.

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Based on interim data from ongoing Stage 3 clinical trials, the vaccine is 91.6% effective in preventing COVID-19.

Domingo said the Sputnik V vaccine can only be used on individuals aged 18 years and older.

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The efficacy rate of the vaccine, he added, is “consistent” and “quite uniform” among all age groups.

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Adverse effects from the vaccine recorded are “mostly mild and transient and similar to common vaccine reactions” and no specific safety concerns were identified.

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Domingo, however,  said close surveillance and monitoring is still needed after immunization.

This is the fourth vaccine that secured an EUA in the country.

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Food and Drug Administration building

The Food and Drug Administration central office

Vaccine czar Carlito Galvez Jr. earlier said the Philippines may receive two million doses of the Sputnik V vaccine this April once it secures an EUA.

He added that the government is in talks with Gamaleya to secure five to 10 million doses of the vaccine.

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TAGS: COVID-19, EUA, FDA, Sputnik V, vaccine

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