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COVID-19: FDA Committee to Review Vaccine Authorization Requests

The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet June 7, to discuss an emergency use authorization (EUA) request Novavax filed Jan. 31 for its COVID-19 vaccine for individuals 18 and older.

The protein sub-unit vaccine is given in two doses, 21 days apart, and can be stored at refrigerator temperatures. In briefing documents, FDA flagged six cases of heart inflammation, including myocarditis and pericarditis, in a 30,000-patient trial conducted from December 2020 to September 2021.

FDA Committee to Consider Pediatric Vaccine Authorization

VRBPAC will meet again June 14, to discuss Moderna’s request for authorization of its COVID-19 vaccine for children and adolescents 6 years through 17 years of age. On June 15, the committee will discuss amending Moderna’s EUA to include infants and children 6 months through 5 years of age, as well as the EUA of the Pfizer-BioNTech COVID-19 vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age. Pfizer recently finished submitting data to FDA for its three-dose COVID-19 vaccine in children 6 months to 4 years old, reporting that the vaccine reduced symptomatic COVID-19 infections by 80.3 percent.

FDA Updates Pfizer COVID-19 Vaccine Fact Sheet

FDA on June 1 authorized changes to the fact sheet for health care providers administering the phosphate buffered saline/sucrose formulation of the Pfizer-BioNTech COVID-19 vaccine for individuals ages 12 and older to reflect additional updated expiration dates. Cartons and vials of the vaccine supplied in multiple dose vials with purple caps with an expiration date of October 2021 through December 2022 printed on the label may remain in use beyond the printed date, as long as storage conditions are met.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Emily Schweich is a senior communications associate for America's Essential Hospitals.

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