Philippine News Agency
Only Pfizer’s Covid-19 vaccine has applied for EUA: FDA
Pfizer-BioNTech has officially filed for an emergency use authorization (EUA) for its COVID-19 vaccine in the Philippines on December 23, 2020.
This filing positions the Pfizer-BioNTech vaccine to potentially be the first available in the country, with availability possibly by the second quarter of 2021.
The Food and Drug Administration (FDA) has a 21-day period to evaluate the EUA application.
FDA Director-General Eric Domingo stated that vaccines previously approved by stringent regulatory authorities would face fewer requirements for Philippine approval.
Domingo clarified that as of Tuesday, December 29, 2020, the Pfizer vaccine is the only application for EUA received by the FDA.
He anticipates the evaluation to be completed within two weeks, focusing on vaccine quality, efficacy, and safety.
Additionally, the FDA has approved one application for a clinical trial for the Janssen vaccine, with trials possibly starting after the New Year.
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