MFDS Conducts Preliminary Review for Pfizer Vaccine Approval for Children Aged 5-11

Pfizer's pediatric COVID-19 vaccine [Image source=AP Yonhap News]

[Asia Economy Reporter Chunhee Lee] On the 1st, the Ministry of Food and Drug Safety announced that it has begun reviewing clinical data submitted by Korea Pfizer for the approval of the COVID-19 vaccine for children aged 5 to 11.

Korea Pfizer submitted immunogenicity results and safety data based on clinical trial results in which a dose of 10μg, one-third of the adult dose, was administered to children aged 5 to 11. The Ministry of Food and Drug Safety plans to review the safety and efficacy based on the submitted clinical data.

Earlier, in the United States, the vaccine for children aged 5 to 11 was granted emergency use authorization on October 29, and vaccinations officially began on November 3. Currently, Pfizer is the only vaccine authorized for use in children and adolescents under 18 in the U.S. In Europe, vaccination for ages 5 to 11 was approved on the 26th of last month.

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