US FDA Delays Review of COVID Vaccine for Children Under 5 Years Old

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[Asia Economy Reporter Park Jihwan] The U.S. Food and Drug Administration (FDA) has postponed the scheduled meeting of its vaccine advisory committee to decide on the emergency use authorization of COVID-19 vaccines for children under 5 years old.

On the 11th (local time), the FDA announced that it had decided to postpone the meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), an external advisory body that was set to discuss the approval of COVID-19 vaccines for children aged 6 months to under 5 years, according to reports by The New York Times (NYT) and CNN.

Janet Woodcock, Acting FDA Commissioner, explained the reason for the postponement, stating, "We were informed by Pfizer that new data has recently emerged," and added, "The postponement is to allow the FDA time to review the additional data."

The FDA advisory committee meeting was originally scheduled for the 15th of this month. Acting Commissioner Woodcock said, "Once we receive the additional clinical trial data on the third dose and complete the evaluation update, we will provide new information regarding the timing of the next advisory committee meeting."

This decision reverses the initial plan to determine vaccine approval based solely on clinical data from two doses. Earlier, Pfizer and BioNTech applied to the FDA on the 1st for emergency use authorization of the COVID-19 vaccine for young children.

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