Pfizer to Submit Clinical Results of COVID-19 Vaccine for Ages 5-11 to FDA This Month

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[Asia Economy Reporter Hyunwoo Lee] Pfizer announced that it expects to submit clinical trial data for its COVID-19 vaccine targeting children aged 5 to 11 to the U.S. Food and Drug Administration (FDA) within this month. It is also reported that clinical data for infants aged 6 months to under 5 years will be disclosed by next month, raising expectations that vaccination for children in the U.S. will soon be in full swing.

On the 14th (local time), Albert Bourla, CEO of Pfizer, stated at the U.S. Health Research Forum, "There is a possibility of submitting clinical trial data for vaccination of children aged 5 to 11 to the FDA by the end of this month," and added, "Clinical trial data for infants aged 6 months to under 5 years will also be disclosed by the end of next month." He further said, "How much time will be taken for approval after submitting the clinical data depends on the FDA."

Accordingly, there is growing anticipation that vaccination for children under 12 will soon be widely implemented in the U.S. Earlier, as in-person classes for the fall semester began in earnest this month, concerns about group infections among children under 12, who are not eligible for vaccination, have increased. According to CNBC, the U.S. Centers for Disease Control and Prevention (CDC) reported that last month, the proportion of severe cases among children under 12 in the U.S. was 2.4%.

U.S. health authorities have also indicated that once Pfizer’s clinical data for children’s vaccines is submitted, they will promptly review it and decide on emergency use authorization. Earlier, on the 10th, the FDA stated that it is "working around the clock" to support vaccine approval for children under 12. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, also publicly stated on the 23rd of last month, "We will move as quickly as possible as soon as pharmaceutical companies submit data."

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