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January 22, 2024 |
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Information on Respiratory Syncytial Virus (RSV) Vaccine Administration Errors in Young Children and Pregnant People |
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Vaccine administration errors are known to occur and are routinely monitored through the Vaccine Adverse Event Reporting System1 (VAERS). Since approval of RSV vaccines and the monoclonal antibody nirsevimab, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have received reports of the Pfizer (Abrysvo) or GSK (Arexvy) RSV vaccines being administered in error to young children. CDC and FDA have also received reports of the GSK RSV vaccine (Arexvy) being administered in error to pregnant people. As of January 17, 2024, the number of reports received by VAERS suggests that these types of errors are uncommon in young children less than 2 years of age (25 reports) and pregnant people (128 reports) relative to an estimated 1 million infants protected from RSV either through infant receipt of nirsevimab or through vaccination of pregnant people.2 In August and September 2023, CDC and the Advisory Committee on Immunization Practices recommended two RSV prevention products to prevent RSV-associated lower respiratory tract disease in infants. Nirsevimab (Beyfortus, Sanofi, and AstraZeneca) is only recommended for infants and some young children at increased risk for severe RSV disease. RSV vaccines (Pfizer Abrysvo, GSK Arexvy) are NOT approved for use in infants or young children. Pfizer (Abrysvo) is the only RSV vaccine recommended for pregnant people. The GSK RSV vaccine (Arexvy) is NOT approved for use during pregnancy. Most reports of administration errors in young children occurred in infants younger than 8 months. Administration errors for both young children and pregnant people occurred in outpatient settings, including doctor’s offices; administration errors of the GSK RSV vaccine (Arexvy) in pregnant people also occurred in pharmacies. Most of these administration error reports described no adverse event. When an adverse event was concurrently reported to VAERS, most reports were classified as nonserious1. CDC, FDA, and other federal agencies continue to monitor the safety of RSV vaccines and reports of vaccine administration errors and will share information with the public as it becomes available. |
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Recommendations for Healthcare Providers who Have Administered Incorrect
RSV Vaccine Products to Their Patients
1 VAERS (managed by CDC and FDA) is a
passive surveillance system that is used to detect possible vaccine safety
problems and also monitors for vaccination errors. VAERS reports may contain
information that is incomplete, inaccurate, coincidental, or unverifiable and
VAERS is not designed to determine if a vaccine caused a health problem. VAERS
data are updated frequently and may change. VAERS reports that meet certain criteria are classified as serious. 2 Calculated using the National Immunization Survey Adult COVID Module (NIS-ACM) nirsevimab coverage data, Vaccine Safety Datalink RSV maternal vaccination coverage data, and CDC Wonder birth data through December 2023. Several assumptions were applied (number of eligible persons, application of coverage estimates to eligible cohort, and no child-parent dyad receiving both immunizations). For More Information Healthcare Provider Toolkit RSV vaccination for pregnant people RSV antibody immunization for infants |
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