On January 31, 2020, the U.S. Department of Health and Human Services (HHS) declared, under Section 319 of the Public Health Service Act, a U.S. public health emergency because of the emergence of a novel virus (a new strain of a virus that has not been seen before). After 13 renewals, the public health emergency expired on May 11, 2023. Although COVID-19 no longer poses the societal emergency that it did when it first emerged late in 2019, COVID-19 remains an ongoing public health challenge.
On April 18, 2023, The U.S. Food and Drug Administration amended the emergency use authorization (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action included authorizing the current bivalent vaccines to be used for all doses administered to individuals 6 months of age and older. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the Unites States and have been removed from the market.
What You Need to Know:
- Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of 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.
- 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.
- 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.
At this stage of the pandemic, data supports simplifying the use of the authorized MRNA bivalent COVID-19 vaccines and the FDA believes this approach will help encourage future vaccinations. Evidence is now available that most of the U.S, populations 5 years 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. COVID-19 continues to be a very real risk for many people, and encourage individuals to consider staying current with vaccination, including a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization and death.
Current Covid-19 Vaccines Authorized for Emergency Use or FDA Approved are:
- Pfizer-BioNtech COVID-19 Vaccine, Bivalent
- Moderna COVID-19 Vaccine, Bivalent
- Janssen Covid-19 Vaccine
- Novavax COVID-19 Vaccine, Adjuvanted