Safety Monitoring of Novavax COVID-19 Vaccine Among Persons Aged ≥12 Years

Abbreviations: MedDRA PT = Medical Dictionary for Regulatory Activities Preferred Term; NH = non-Hispanic; VAERS = Vaccine Adverse Event Reporting System.
*Reports for persons aged ≥18 years were received by VAERS and had vaccination dates during July 13, 2022–March 13, 2023; reports for persons aged 12–17 years were received and had vaccination dates during August 19, 2022–March 13, 2023; includes reports with missing vaccination dates. When fewer than three reports were received within a category, the number is noted as "<3" to prevent inadvertent identification of the vaccine recipient.
^†https://www.meddra.org/how-to-use/basics/hierarchy
^§VAERS reports are classified as serious if any of the following are reported: hospitalization, prolongation of hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr
**Includes Hispanic or Latino ethnicity of unknown race.
^††Not mutually exclusive.

Authors and Disclosures

Brittney Romanson, MPH¹, Pedro L. Moro, MD¹, John R. Su, MD, PhD¹, Paige Marquez, MSPH¹, Narayan Nair, MD², Brendan Day, MD², Allison DeSantis, MPH³ and Tom T. Shimabukuro, MD<sup>1

1</sup>Division of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases, CDC; ²Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland; ³Immunization Services Division, National Center for Immunization and Respiratory Diseases, CDC.

Corresponding author
Brittney Romanson, uzu4@cdc.gov.

All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.