The CDC and FDA said that vaccine administration errors monitored through the Vaccine Adverse Event Reporting System (VAERS) have been identified with RSV vaccines and the monoclonal antibody nirsevimab.
Specifically, the CDC and FDA have received reports of the Pfizer (Abrysvo) or GSK (Arexvy) RSV vaccines being administered in error to young children. In addition, the GSK RSV vaccine (Arexvy) was erroneously administered to pregnant women.
“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,” according to an emergency risk communications release from the agencies.
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) and palivizumab (Synagis).
Nirsevimab is recommended for:
• All infants aged younger than 8 months who were born during RSV season or who are entering their first RSV season. Except in rare circumstances, most infants aged younger than 8 months do not need nirsevimab if they were born 14 or more days after their mother got RSV vaccine
• Some children aged 8 through 19 months who are at increased risk for severe RSV disease and entering their second RSV season.
Palivizumab (Synagis) use is limited to:
• Some children aged younger than 24 months with certain conditions that place them at increased risk for severe RSV disease. It must be given once a month during RSV season.
Neither of the two RSV vaccines licensed for use in adults aged 60 years and older in the United States, RSVPreF3 (Arexvy) from GSK and RSVpreF (Abrysvo) from Pfizer, are approved for use in infants or young children, public health officials emphasize. The only RSK vaccine approved for pregnant women is Pfizer’s Abrysvo, according to the CDC/FDA information.
Most reports of administration errors in young children occurred in infants aged younger than 8 months, according to the report.
“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,” the press release states, adding that most describe no serious adverse events.
Even when adverse events were concurrently reported to VAERS, most reports were classified as nonserious.
The CDC and FDA recommend the following for healthcare providers who have administered incorrect RSV vaccines to their patients:
• 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
• For pregnant women 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 aged younger than 8 months) should receive nirsevimab during RSV season (October through March in most of the continental United States).
“Healthcare providers and facilities should ensure use of the correct RSV prevention product in the correct population and take actions to prevent vaccine administration errors, including automating error prevention alerts in electronic health record systems, ensuring proper education and training on vaccine recommendations, paying close attention to labeling, and following proper storage and administration best practices,” according to the CDC Clinician Outreach and Community Activity, which added that healthcare providers are strongly encouraged to report vaccine administration errors to VAERS.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
