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Minnesota Department of Health
April 28, 2022
On April 26, Pfizer and BioNTech submitted an application to the Food and Drug Administration (FDA) for emergency use authorization of a 10-mcg booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5-11 years of age. More information, including data from Pfizer’s Phase 2/3 clinical trial, can be found in BioNTech’s press release: Pfizer and BioNTech Submit Application for U.S. Emergency Use Authorization for a COVID-19 Vaccine Booster Dose in Children 5 Through 11 Years of Age.
Booster doses for children 5-11 years of age are not authorized by the FDA or recommended by the Center for Disease Control and Prevention (CDC) at this time. We will communicate any updates as soon as they become available.
Today, Moderna announced they have submitted applications to the FDA for emergency use authorization (EUA) of their COVID-19 vaccine in children 6 months up to 2 years of age and 2 years up to 6 years of age. Both requests are based on a 25-mcg two-dose primary series of their mRNA-1273 vaccine. For additional information, refer to Moderna’s April 28, press release: Moderna Files for Authorization of Its COVID-19 Vaccine in Young Children Six Months to Under Six Years of Age.
The FDA has not scheduled any meetings for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss Moderna’s applications for an EUA in these age groups. We will relay more information in upcoming bulletins.
On April 21, the CDC updated the Interim Clinical Considerations for Use of COVID-19 Vaccines with guidance on second booster dose options and timing for those who are eligible, along with guidance for timing of first and second boosters after recent SARS CoV-2 infection. A new document, Clinical Considerations: Second COVID-19 Vaccine Booster Dose was also included and can be found in the reference materials section at the top of the page.
While this update focuses on a second booster, it is important clinicians keep in mind that the primary series with a booster provides the greatest benefit and protection against hospitalization and death. Providers should focus on getting all people up to date with their COVID-19 vaccinations.
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