MFDS Begins Approval Review for Pfizer Vaccine for Infants and Toddlers Aged 6 Months to 4 Years

[Image source=Yonhap News]

[Asia Economy Reporter Kim Young-won] The Ministry of Food and Drug Safety (MFDS) has begun the approval review for Pfizer's COVID-19 vaccine intended for infants and young children.

The MFDS announced on the 1st that it has started the review process for the product following Korea Pfizer's application for import approval of the COVID-19 original virus vaccine for ages 6 months to 4 years on the 31st of last month.

Moderna also applied for approval of its original virus COVID-19 vaccine for those aged 6 months and older on June 3rd, and the MFDS is currently reviewing the application.

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) approved COVID-19 vaccinations from Pfizer and Moderna for infants aged 6 months and older in June of this year.

The efficacy and effectiveness of the newly applied product, 'Comirnaty 0.1mg/mL (for ages 6 months to 4 years),' is for the prevention of COVID-19 caused by the SARS-CoV-2 virus in children aged 6 months to 4 years, and it contains the same active ingredient (tozinameran) as Pfizer's vaccines for adults, adolescents, and children previously approved by the MFDS.

The MFDS plans to promptly and thoroughly review the clinical, non-clinical, quality, manufacturing, and quality control (GMP) data submitted with this application, consult vaccine experts including infectious disease specialists on the vaccine's safety and efficacy, and then decide whether to grant approval.

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