Top 5 Takeaways

1. Bivalent Booster Recommendation: In fall 2022, the CDC recommended a bivalent mRNA COVID-19 vaccine booster dose for individuals aged 5 years and older, to be administered at least 2 months after completing the primary series or after receiving a monovalent booster dose.
2. Booster Dose Composition: Pfizer-BioNTech and Moderna bivalent booster vaccines contain equal amounts of spike mRNA from the ancestral and Omicron BA.4/BA.5 strains, designed to improve protection against these sublineages.
3. Vaccine Effectiveness Decline: Monovalent COVID-19 vaccines showed decreased effectiveness over time, particularly against the Omicron variant. A third monovalent booster dose provided increased protection, but its effectiveness waned over time, especially against recent Omicron sublineages.
4. Clinical Trials Data: Clinical trials for Moderna and Pfizer-BioNTech bivalent vaccines demonstrated that they meet superiority criteria for Omicron antibodies, with similar or lower rates of adverse events compared to monovalent boosters.
5. Equity and Global Access: The ACIP emphasized the importance of equitable COVID-19 vaccination coverage and global access to vaccines, including for younger age groups and minority groups disproportionately affected by COVID-19.

Original Article Author and Citation

Corresponding Author

Hannah G. Rosenblum, qds8@cdc.gov

Suggested Citation

Rosenblum HG, Wallace M, Godfrey M, et al. Interim Recommendations from the Advisory Committee on Immunization Practices for the Use of Bivalent Booster Doses of COVID-19 Vaccines — United States, October 2022. MMWR Morb Mortal Wkly Rep 2022;71:1436–1441. DOI: http://dx.doi.org/10.15585/mmwr.mm7145a2 .

Summary

The CDC, following the recommendation of the Advisory Committee on Immunization Practices (ACIP), now advises a bivalent mRNA COVID-19 vaccine booster for those aged ≥5 years. This comes in response to the decreased efficacy of monovalent vaccines against the Omicron variant and its sublineages.

Methods

The ACIP’s decision was informed by extensive review meetings and the Evidence to Recommendations (EtR) Framework. This considered vaccine effectiveness, clinical trial data, safety, public health importance, and resource utilization.

Discussion

The discussion highlights the decline in vaccine effectiveness over time, the emergence of Omicron variants, and the superior response of bivalent boosters in clinical trials. It also underscores the ongoing review of safety data, including myocarditis and pericarditis risks.

Conclusion

The new bivalent booster recommendation aims to provide enhanced protection against the evolving SARS-CoV-2 variants, particularly Omicron. This step is critical in the broader strategy to manage COVID-19, especially in populations at increased risk of severe illness. The ACIP continues to prioritize high and equitable vaccine coverage and stresses the importance of global vaccine access.

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