Here We Go: FDA Now Recommends that Healthy People Aged 5 to 65 Should Get Only One Dose of the mRNA Bivalent COVID Vaccine, No More Additional Boosters Required

The U.S. Food and Drug Administration (FDA) now advises that healthy individuals between the ages of 5 and 65 should receive only a single dose of the mRNA bivalent COVID vaccine, with no further booster shots required.

The bivalent COVID-19 vaccines include a component of the original virus strain and a component of the omicron BA.4/BA.5 strains. Recall, the reformulated bivalent COVID boosters were not tested on humans – only mice.

The Johnson & Johnson vaccine, monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

JUST IN – FDA now recommends only a single bivalent mRNA injection, rather than multiple doses of the original monovalent injection, for “most unvaccinated individuals.”

— Disclose.tv (@disclosetv) May 18, 2023

Key points to note from the FDA’s updated guidance are as follows:

• 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.
• 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.
• 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.
• 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.
• Most unvaccinated individuals may receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines.
• 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.
• 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.

According to FDA, the recommendation for an additional bivalent dose for individuals aged 65 and older is based on evidence of waning immunity in this age group. Furthermore, the agency stated that immunocompromised individuals may require additional doses for optimal protection.

“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

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