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FDA Meeting to Discuss Pediatric COVID-19 Vaccine Postponed

The FDA meeting to discuss extending the Pfizer/BioNTech EUA to children aged 6 months to 4 years has been postponed until data on a third dose has been studied.

The FDA has announced that the Vaccines and Related Biological Products Advisory Committee meeting that was originally scheduled for February 15, 2022 to discuss the Pfizer/BioNTech COVID-19 vaccine in children aged 6 months to 4 years, has been postponed as a result of Pfizer notifying the agency of new data related to the third dose. The rescheduled date has not been announced yet.1

In the release of the announcement, the FDA stated that they are weighing the need to act with urgency but also consider the safety and effectiveness of the vaccine and believe that information about the third dose will help.

Until the agency does make a decision, the guidance to keep young children remains the same: social distance when possible, mask in accordance to current public health recommendations, and vaccination and boosters for family members and caregivers who are eligible to receive them.

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This article originally appeared on Contemporary Pediatrics.

Reference

  1. Coronavirus (COVID-19) Update: FDA postpones advisory committee meeting to discuss request for authorization of Pfizer-BioNTech vaccine for children 6 months throuhg 4 years of age. News release. FDA. February 11, 2022. Accessed February 11, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-postpones-advisory-committee-meeting-discuss-request-authorization

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