Top 5 Takeaways

1. Full FDA Approval: On January 31, 2022, the FDA granted full approval to the Moderna COVID-19 vaccine for individuals aged ≥18 years.
2. ACIP Recommendation: On February 4, 2022, the Advisory Committee on Immunization Practices (ACIP) issued a standard recommendation for the use of the Moderna COVID-19 vaccine in adults aged ≥18 years.
3. Extended Dose Interval: CDC guidance suggests that an 8-week interval between primary series doses of mRNA vaccines might be optimal for some individuals, especially males aged 12–39 years, to reduce the risk of myocarditis and enhance vaccine effectiveness.
4. Vaccine Efficacy: The Moderna COVID-19 vaccine shows high efficacy in preventing symptomatic COVID-19 (92.7%), hospitalization (95.9%), and death (100%) in clinical trials.
5. Safety Profile: The vaccine is associated with some adverse reactions, including anaphylaxis and myocarditis, but the benefits of vaccination outweigh these risks.

Original Article Author and Citation

Corresponding Author

Sara E. Oliver, yxo4@cdc.gov

Suggested Citation

Wallace M, Moulia D, Blain AE, et al. The Advisory Committee on Immunization Practices’ Recommendation for Use of Moderna COVID-19 Vaccine in Adults Aged ≥18 Years and Considerations for Extended Intervals for Administration of Primary Series Doses of mRNA COVID-19 Vaccines — United States, February 2022. MMWR Morb Mortal Wkly Rep 2022;71:416–421. DOI: http://dx.doi.org/10.15585/mmwr.mm7111a4

Summary

On January 31, 2022, the FDA granted full approval to the Moderna COVID-19 vaccine for individuals aged ≥18 years. Following this, on February 4, 2022, the ACIP issued a standard recommendation for its use. CDC guidance also suggested that an 8-week interval between primary series doses of mRNA vaccines might be optimal for some individuals, particularly males aged 12–39 years, to reduce the risk of myocarditis and enhance vaccine effectiveness. The Moderna vaccine has shown high efficacy in preventing symptomatic COVID-19, hospitalization, and death, with a safety profile that supports its benefits outweighing the risks.

Methods

The ACIP COVID-19 Vaccines Work Group conducted a systematic review of published and unpublished scientific evidence, using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach to assess the certainty of evidence. The review included data from clinical trials, observational studies, and postauthorization safety monitoring systems such as VAERS and VSD. The evidence was presented to ACIP at a public meeting on February 4, 2022.

Discussion

The review concluded that the Moderna COVID-19 vaccine is highly effective in preventing COVID-19-related outcomes, including symptomatic infection, hospitalization, and death. The vaccine’s safety profile was also considered acceptable, with the benefits outweighing the risks. The recommendation for an extended interval between doses for certain populations was based on evidence suggesting reduced myocarditis risk and improved vaccine effectiveness with a longer interval.

Conclusion

The ACIP’s standard recommendation for the use of the Moderna COVID-19 vaccine in adults aged ≥18 years, along with the guidance for an extended dose interval, underscores the vaccine’s efficacy and safety. These recommendations aim to optimize vaccination outcomes and address public health needs effectively.

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