FDA cancels Sputnik V inspection trip after Gamaleya submits docs

The FDA has canceled its planned inspection trip to Russia because the Gamaleya Institute has already submitted the necessary documents for the Sputnik V vaccine's emergency use authorization (EUA).

An FDA team was originally scheduled to travel to Russia to inspect the Gamaleya manufacturing facility.

Gamaleya submitted its EUA application after withdrawing a previous bid for a clinical trial in the Philippines.

The Philippines may order 5 to 10 million doses of Sputnik V once it secures EUA approval.

The FDA has already granted EUA for vaccines from Pfizer-BioNTech, AstraZeneca, and Sinovac.

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