Russia's Gamaleya applies for PH COVID-19 vaccine EUA
Russia's Gamaleya Research Institute has withdrawn its application to conduct Phase III clinical trials of the Sputnik V vaccine in the Philippines and instead applied for emergency use authorization (EUA) on January 7.
The FDA received the EUA application but instructed Gamaleya to submit missing documents before the review process can begin.
Gamaleya's decision to apply for EUA, rather than conducting clinical trials, aims to bring its vaccine to a larger number of people more quickly.
US drugmaker Pfizer and Britain’s AstraZeneca have also filed for emergency use with the FDA.
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