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:
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: