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To: Maine Immunization Program Providers
From: Maine Immunization Program
Subject: Discontinuation of Pfizer and Moderna Monovalent mRNA COVID-19 Vaccines
Date: April 18, 2023
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations.
At this time, the monovalent mRNA Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States, effective immediately. Please stop all use of monovalent mRNA COVID-19 vaccines, both Moderna and Pfizer.
What You Need to Know:
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Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of a bivalent vaccine may receive a single dose of a bivalent vaccine.
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Most individuals who have already received a single dose of the bivalent vaccine are not currently eligible for another dose. The FDA intends to make decisions about future vaccination after receiving recommendations on the fall strain composition at an FDA advisory committee in June.
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Individuals 65 years of age and older who have received a single dose of a bivalent vaccine may receive one additional dose at least four months following their initial bivalent dose.
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Most individuals with certain kinds of immunocompromise who have received a bivalent COVID-19 vaccine may receive a single additional dose of a bivalent COVID-19 vaccine at least 2 months following a dose of a bivalent COVID-19 vaccine, and additional doses may be administered at the discretion of, and at intervals determined by, their healthcare provider. However, for immunocompromised individuals 6 months through 4 years of age, eligibility for additional doses will depend on the vaccine previously received.
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Most unvaccinated individuals may receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines.
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Children 6 months through 5 years of age who are unvaccinated may receive a two-dose series of the Moderna bivalent vaccine (6 months through 5 years of age) OR a three-dose series of the Pfizer-BioNTech bivalent vaccine (6 months through 4 years of age). Children who are 5 years of age may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
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Children 6 months through 5 years of age who have received one, two or three doses of a monovalent COVID-19 vaccine may receive a bivalent vaccine, but the number of doses that they receive will depend on the vaccine and their vaccination history.
ACIP will meet tomorrow, Wednesday April 19, 2023. MIP will continue to provide information as it becomes available throughout the week. This will include updated COVID-19 vaccine schedules, clinical guidance, and information on vaccine disposal.
Updated FDA fact sheets here:
Resources:
Should you have any questions, please contact us at (207) 287-3746 or email: ImmunizeME.DHHS@maine.gov.
Thank you for your continued efforts to ensure all Mainers have access to COVID-19 vaccination.
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