The Moderna COVID-19 Vaccine, Bivalent, is approved for use as a single booster dose in people aged 18 and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is approved for use as a single booster dose in people aged 12 and up.
The FDA-authorized monovalent COVID-19 vaccines, which have been delivered to millions of individuals in the United States since December 2020, contain a component from the original strain of SARS-CoV-2.
why you should know:
- The authorised bivalent COVID-19 vaccines, or updated boosters, contain an mRNA component from the original strain to provide a broadly protective immune response against COVID-19, as well as an mRNA component shared by the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant.
The BA.4 and BA.5 omicron variant lineages are now causing the majority of COVID-19 cases in the United States and are expected to circulate during fall and winter. The Vaccines and Related Biological Products Advisory Committee of the CDC voted unanimously in June to include an omicron component in COVID-19 booster vaccines. - The BA.4 and BA.5 omicron variant lineages are now causing the majority of COVID-19 cases in the United States and are expected to circulate during fall and winter. The Vaccines and Related Biological Products Advisory Committee of the CDC voted unanimously in June to include an omicron component in COVID-19 booster vaccines.
- With today’s approval, monovalent mRNA COVID-19 vaccinations are not permitted as booster doses for people aged 12 and up.
- As new data and submissions arrive, the FDA will work promptly to analyse them in order to support the authorisation of bivalent COVID-19 boosters for other age groups.
- The bivalent COVID-19 vaccines are likely to give improved protection against the currently circulating omicron form based on the data supporting each of these authorizations. Individuals who receive a bivalent COVID-19 immunisation may encounter the same adverse effects as those who obtain authorised or approved monovalent mRNA COVID-19 vaccines.
When and who is eligible for a single booster dose:
Individuals aged 18 and up are eligible for a single booster dose of the Moderna COVID-19 Vaccine, Bivalent if it has been at least two months since their original vaccination or the most recent booster dose with any authorised or approved monovalent COVID-19 vaccine.
Individuals 12 years of age and older are eligible for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if they have completed primary vaccination or have received the most recent booster dose with any authorised or approved monovalent COVID-19 vaccine in the previous two months.
“The COVID-19 vaccines, including boosters, continue to save countless lives and avoid the most serious COVID-19 outcomes (hospitalisation and death),” FDA Commissioner Robert M. Califf, M.D. remarked. “As we enter autumn and spend more time indoors, we highly recommend everyone who is eligible to consider taking a booster dose of a bivalent COVID-19 vaccination to provide improved protection against presently circulating strains.”