MFDS Grants National Release Approval for Pfizer COVID-19 Vaccine for Ages 5-11

299,000 Times Volume

[Image source=Yonhap News]

[Asia Economy Reporter Ki Ha-young] The Ministry of Food and Drug Safety announced on the 29th that it has granted national release approval for 299,000 doses of Korea Pfizer's COVID-19 vaccine 'Comirnaty 0.1 mg/mL (for ages 5-11)'.

National release approval is a system in which the state comprehensively evaluates the results of national testing and the manufacturer's production and testing results for each manufacturing lot before the vaccine is distributed on the market, to confirm quality once more.

The Ministry of Food and Drug Safety stated that after reviewing the national testing and the manufacturer's production and testing data for Comirnaty for ages 5-11, effectiveness, safety, and quality were confirmed, leading to the decision to grant national release approval.

This product is an mRNA vaccine developed and produced by Pfizer to prevent COVID-19 infection in children aged 5 to 11. It contains the same active ingredient, tozinameran, as the previously approved 'Comirnaty' and 'Comirnaty 0.1 mg/mL', but the dose per injection is about one-third (10 μg).

A Ministry of Food and Drug Safety official said, "We expect that the vaccine granted national release approval this time will help prevent COVID-19 in children and reduce severe progression."

This content was produced with the assistance of AI translation services.