Top 5 Takeaways

1. Emergency Use Authorization Granted: The FDA issued an EUA for the Novavax COVID-19 vaccine on July 13, 2022, for primary immunization in adults aged ≥18 years.
2. ACIP’s Interim Recommendation: On July 19, 2022, the ACIP recommended the Novavax vaccine for persons aged ≥18 years as a 2-dose primary series for COVID-19 prevention.
3. High Vaccine Efficacy: In the per-protocol efficacy analysis, the vaccine demonstrated an 89.6% efficacy against symptomatic COVID-19, with the Alpha variant being the predominant strain during the study.
4. Additional Option for Unvaccinated Adults: The Novavax vaccine, being an adjuvanted, protein subunit-based option, increases flexibility and choice for vaccination among unvaccinated adults.
5. Concerns and Ongoing Surveillance: Cases of myocarditis or pericarditis were reported, suggesting a possible causal relationship with the vaccine, highlighting the importance of ongoing safety surveillance. It should be noted that these cases were incredibly rare, with 6 cases being reported within 20 days of vaccination out of a total of 41,546 individuals vaccinated. For those individuals who have contracted COVID for instance, pericarditis and myocarditis have a rate ten times higher, at minimum.

Original Article Author and Citation

Corresponding Author

Evelyn Twentyman, ydj2@cdc.gov.

Suggested Citation

Twentyman E, Wallace M, Roper LE, et al. Interim Recommendation of the Advisory Committee on Immunization Practices for Use of the Novavax COVID-19 Vaccine in Persons Aged ≥18 years — United States, July 2022. MMWR Morb Mortal Wkly Rep 2022;71:988–992. DOI: http://dx.doi.org/10.15585/mmwr.mm7131a2.

Summary

This report outlines the FDA’s EUA and the ACIP’s interim recommendation for the Novavax COVID-19 vaccine as a primary 2-dose series for adults aged ≥18 years. It highlights the vaccine’s high efficacy and its role in increasing vaccination options for unvaccinated adults.

Methods

The evidence supporting the use of the Novavax vaccine included data from a large phase III clinical trial and additional safety data from other trials and postmarketing surveillance, following the GRADE approach and the Evidence to Recommendation (EtR) Framework.

Discussion

The discussion emphasizes the importance of the Novavax vaccine in providing an additional option for COVID-19 prevention, particularly among unvaccinated adults, and the critical need for ongoing safety monitoring due to reports of myocarditis or pericarditis.

Conclusion

The availability of the Novavax vaccine, with its high efficacy and the flexibility it offers, is crucial for increasing vaccination rates among unvaccinated adults, while ongoing surveillance is essential to monitor potential adverse events.

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