COCA Now Message on RSV Vaccines Administered in Error

Jan. 24, 2024
Clinicians received an email message this week on the CDC and FDA receiving reports of RSV vaccines being administered in error to young children and pregnant people

On Jan. 22, a Clinician Outreach and Communication Activity (COCA) Now email message informed clinicians that since the 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 (Abrsyvo) or GSK (Arexvy) RSV vaccines being administered in error to young children.

The 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 Vaccine Adverse Event Reporting System (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.

The message says that “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. “

The majority of reports of administration errors in young children occurred in those younger than 8 months, according to the message. Administration errors in young children and pregnant individuals occurred in outpatient settings and administration errors for the GSK RSV vaccine (Arexvy) also occurred in pharmacies. When an adverse event was concurrently reported to VAERS, most reports were classified as nonserious.

The message provides recommendations for healthcare providers who have adminsitrared incorrect RSV vaccine products to their patients including for infants and young children who are recommended to receive nirsevimab but received either the Pfizer (Abrysvo) or GSK (Arexvy) RSV vaccine in error, administer a dose of nirsevimab and for pregnant people who have received the GSK RSV vaccine (Arexvy) in error, do not give a dose of the Pfizer RSV vaccine (Abrysvo). Instead, the infant (if younger than 8 months) should receive nirsevimab during RSV season (October through March in most of the continental United States).

The CDC has the message.