This morning, the US Food and Drug Administration (FDA) announced significant changes intended to simplify COVID-19 vaccination.

The FDA has authorized the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines (original and Omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older. This means a bivalent mRNA vaccine is now recommended for all primary and booster COVID-19 vaccine doses.

On January 26, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) first recommended a unified strain composition for COVID-19 primary and booster vaccines, intending to simplify vaccinations. VRBPAC unanimously voted YES to the following question:

“Does the committee recommend harmonizing the vaccine strain composition of primary series and booster doses in the US to a single composition, e.g., the composition for all vaccines administered currently would be a bivalent vaccine (Original plus Omicron BA.4/BA.5)?”

Today, the FDA implemented their advisory committee’s recommendation. Notably, this means the monovalent (wild-type Wuhan strain) Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the US.

“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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Evidence is now available that most of the US population 5 years of age and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines.”

Individuals who previously received a monovalent COVID-19 vaccine but have not yet received an updated bivalent dose, previously only available as a booster, are recommended to receive a single dose of a bivalent vaccine.

Persons who are unvaccinated against COVID-19 may receive a single dose of a bivalent vaccine, rather getting than multiple doses of original monovalent mRNA vaccines to complete a primary series.

Unvaccinated children 6 months-5 years of age can receive a 2-dose series of the Moderna bivalent vaccine (6 months-5 years of age) OR a 3-dose series of the Pfizer-BioNTech bivalent vaccine (6 months-4 years of age). Children who are 5 years and older may receive 2 doses of the Moderna bivalent vaccine or 1 dose of the Pfizer-BioNTech bivalent vaccine.

Children 6 months-5 years of age who have received 1, 2, or 3 doses of a monovalent COVID-19 vaccine are eligible for a bivalent vaccine, but the number of doses they can receive is dependent upon their vaccination history.

However, most individuals who already received a single dose of the bivalent Pfizer-BioNTech or Moderna booster are not yet eligible for another dose. The FDA will likely announce future vaccination recommendations after determining fall’s vaccine strain composition in their June advisory meeting.

Similar to the FDA’s deliberation on yearly influenza vaccine strain composition, VRBPAC will assess which COVID-19 variants and lineages are most likely to circulate in the next year. After the FDA chooses specific strains for the next generation of COVID-19 vaccines, manufacturers will update vaccine formulations for fall 2023, at which time most individuals are recommended to receive an additional dose.

Exceptions are granted to individuals who are 65 years or older, who are eligible to receive a second dose of a bivalent vaccine at least 4 months after their initial bivalent dose. After 2 months, most immunocompromised persons who previously received a single dose of a bivalent vaccine can receive an additional dose to ensure they mount an adequate immune response.

“COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine,” said Marks. “The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”

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