![]() ![]() The safety and effectiveness of Moderna COVID-19 Vaccine, Bivalent is based on FDA’s previous analyses of clinical trials data of monovalent Moderna COVID-19 Vaccine in individuals 6 months of age and older and an investigational bivalent Moderna COVID-19 vaccine (original and omicron BA.1) in individuals 18 years of age and older. Additionally, based on evidence from studies conducted previously, immunocompromised individuals may require additional doses. ![]() A second bivalent dose for individuals 65 years of age and older is supported by data showing the waning of immunity in this population over time and its restoration by an additional dose. The use of bivalent COVID-19 vaccines for all doses administered to individuals 6 months of age and older is supported by the data described below, as well as post-marketing data, including real-world data, with the monovalent and bivalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children. population 5 years of age and older now have antibodies as a result of either vaccination or infection against SARS-CoV-2. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”Īvailable data show that almost all of the U.S. 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. 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. “Evidence is now available that most of the U.S. “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. ![]() 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.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 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).Most unvaccinated individuals may receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines.However, for immunocompromised individuals 6 months through 4 years of age, eligibility for additional doses will depend on the vaccine previously received. 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. ![]()
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