FDA awaits Pfizer EUA for 5-11 vaccine

The Food and Drug Administration (FDA) is expecting a submission from Pfizer for an emergency use authorization (EUA) to vaccinate children aged 5 to 11 against COVID-19.

Health Undersecretary Maria Rosario Vergeire confirmed that no manufacturer has yet applied for an EUA for this age group in the Philippines.

Vergeire noted that manufacturers typically submit applications to other countries shortly after receiving approval from the US FDA, which authorized the Pfizer-BioNTech vaccine for 5 to 11-year-olds in late October.

The Philippine FDA will wait for the application, evaluation, and issuance of an EUA before proceeding with vaccinations for this age group.

Pfizer has also applied for an EUA for its vaccine to be used as a booster shot for healthcare workers and individuals with comorbidities, as have AstraZeneca, Sinovac, and the Gamaleya Research Institute.