Dear USET/USET SPF Family,
On August 31, 2022, the FDA amended the emergency use authorizations for Pfizer-BioNTech and Moderna COVID-19 vaccines to authorize a single-dose bivalent booster. On September 1, 2022, the CDC endorsed the Advisory Committee on Immunization Practices’ recommendation for use of the updated bivalent COVID-19 booster vaccines.
The single-dose Pfizer-BioNTech booster is authorized for use in adults, age 12 and older, at least two months after receiving their primary vaccine series. The single-dose Moderna booster is authorized for use in adults, age 18 and older, at least two months after receiving their primary vaccine series. The monovalent mRNA COVID-19 vaccine is no longer authorized as a booster dose for those 12 years and older. Those eligible to receive the bivalent vaccine do not need to get it from the same manufacturer that they received for their primary series or previous booster.
The bivalent booster dose includes two different mRNA components of the SARS-C0V-2 virus. One mRNA component is the original strain and the other is the BA.4 and BA.5 lineage of the omicron variant. The original strain is broadly protective, and the additional omicron strain is due to the mutation on the spike protein that made BA.4 and BA.5 more infectious and less susceptible to the original vaccine strain. Currently, the majority of COVID-19 cases are due to the BA.4 and BA.5 lineages, which are predicted to continue to circulate this fall and winter. Distribution of the updated vaccine has begun, with widespread availability expected in early Fall.
Key Points:
- Pfizer-BioNTech single dose bivalent COVID-19 booster dose authorized for ages 12 & older
- Moderna single dose bivalent COVID-19 booster dose authorized for ages 18 & older
- Monovalent mRNA COVID-19 vaccine booster dose no longer authorized for ages 12 & older
Additional guidance is linked below for clinical reference on the new booster dose. The USET TEC is available to assist with any questions or concerns. Please do not hesitate to contact us at usetepi@usetinc.org.
Sources
FDA News Release: August 31, 2022 Bivalent COVID Vaccine Booster Dose
CDC Media Statement: First Updated COVID-19 Booster
CDC Interim Clinical Considerations for COVID-19 Vaccines: Bivalent Boosters
CDC: Evidence to Recommendations Framework: Bivalent COVID-19 Vaccine Booster Doses
CDC Fall Vaccination Operational Planning Guide, August 16, 2022
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