The Centers for Disease Control and Prevention (CDC) is urging health care providers to ensure they are using the right respiratory syncytial virus (RSV) product for infants, toddlers and pregnant people after reports of errors.
While errors are rare, at least 25 children under 2 years have been given an adult vaccine, while 128 pregnant people have been given a vaccine not approved during pregnancy, according to the CDC.
The errors were reported to the Vaccine Adverse Event Reporting System (VAERS) and occurred in outpatient settings like doctor’s offices. Pharmacies also reported errors in vaccination of pregnant people. Most errors did not include an adverse event. When adverse events occurred, they typically were not serious.
Nirsevimab (Beyfortus) from Sanofi and AstraZeneca is a monoclonal antibody approved for infants and some high-risk toddlers. Abrysvo by Pfizer and Arexvy from GSK are vaccines recommended for adults 60 years and older using shared clinical decision-making. Abrysvo also is recommended during weeks 32 through 36 of pregnancy to protect infants.
The CDC made the following recommendations to health care providers:
- Administer nirsevimab to eligible infants and children even if the infant or child received Abrysvo or Arexvy in error.
- For pregnant people who received Arexvy in error, do not give a dose of Abrysvo. Instead, give nirsevimab to their infants who are under 8 months of age during the RSV season (October through March in most of the U.S.)
- Take steps to prevent immunization errors, including automating error prevention alerts in electronic health record systems, ensuring proper education and training, paying close attention to labeling and following proper storage and administration best practices.
- Report vaccine administration errors to VAERS.
- Submit questions about vaccine administration errors to [email protected]. For complex issues, request a consultation on a vaccine administration error.
Earlier this month, the CDC encouraged clinicians to immunize all eligible children “as quickly as possible” and not save doses for infants born later in the season when circulation and risk for exposure to RSV may be lower. Sanofi is releasing 230,000 extra doses of nirsevimab this month, and the CDC said clinicians can return to the original recommendations for using it as supplies increase.
The additional supplies will include both 50 milligram (mg) and 100 mg doses and will be distributed through the Vaccines for Children program and the private market. The CDC is encouraging clinicians to work with Sanofi (call 855-BEYFORTUS) and their state immunization program to place orders, especially in areas where RSV has not yet peaked.
Resources
- Information from the CDC on preventing vaccine administration errors
- Information from the CDC on using nirsevimab
- Information from the CDC on RSV vaccination for pregnant people
- AAP RSV resources, including information on ordering, dosing, coding and a visual guide for nirsevimab administration
- AAP News article “How to use new CPT codes for administration of RSV immunizations”
- VFC operations guide addendum for nirsevimab
- Information for parents from HealthyChildren.org on RSV symptoms and when to call a doctor
- Pediatrics in Review article “Implications of Food and Drug Administration Approval of Respiratory Syncytial Virus Prophylactic Medications”
