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  • The MFDS reviews Pfizer's vaccine permission for infants
  • by Lee, Hye-Kyung | translator Choi HeeYoung | Sep 2, 2022 06:03am
The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 1st that Pfizer Korea has begun reviewing the item as it applied for permission for imported items of the early COVID-19 vaccine for infants (6 months to 4 years old).

The efficacy of "Comirnati 0.1mg/mL (for ages 6 months to 4 years)" applied this time is "Prevention of COVID-19 by the SARS-CoV-2 virus at ages 6 months to 4 years old," and the active ingredients are the same as "Comirnati 0.1mg/mL" (5 to 11 years old) approved by the MFDS.

It plans to quickly and closely review clinical, nonclinical, quality, and GMP data submitted when applying for the item license, and consult vaccine experts, including infectious medicine experts,
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