Nearly three dozen babies and young children have received respiratory syncytial virus (RSV) vaccines, which are only approved for adults, according to a brief CDC report.
Data from the Vaccine Adverse Event Reporting System (VAERS) revealed 27 reports of the Pfizer RSV vaccine (Abrysvo) and seven reports of the GSK RSV vaccine (Arexvy) being mistakenly administered to children under the age of 2 between Aug. 21, 2023 and March 18, 2024, Pedro Moro, MD, MPH, of the CDC in Atlanta, and colleagues detailed in Pediatrics.
"While rare, vaccine administration errors are known to occur and may increase after a new vaccine or product is introduced," Moro told MedPage Today in an email.
Thirty-one of the children who received the vaccines were infants under 8 months of age. In 21 of the cases, the vaccines were given in family medicine practices.
"Healthcare facilities that provide preventive care for children and adults might store and administer Pfizer and GSK RSV vaccines, other routine vaccines, and nirsevimab [Beyfortus]," Moro and colleagues wrote in the report. "Thus, the potential exists for Pfizer or GSK RSV vaccines to be administered in error to infants and young children."
Eric Simões, MD, a pediatric infectious diseases expert at Children's Hospital Colorado in Aurora, told MedPage Today that he was "not surprised" by the vaccine errors. "Mistakes will happen, especially with COVID vaccines being given to [both] adults and children, with pneumococcal vaccines being first given to children and now to adults, etc."
Simões said that he did not personally know of any cases where the RSV vaccines had been administered to children, but emphasized that "adult RSV vaccines should absolutely not be given to children."
The Pfizer vaccine is approved for use in pregnant individuals at 32 through 36 weeks gestational age, to prevent serious RSV cases in infants, and both the Pfizer vaccine and GSK vaccine are approved and recommended for adults 60 years of age and older.
Twenty-seven of the reports noted no adverse health events associated with the erroneous vaccines, but the remaining seven described at least one adverse event. One of those events occurred in an infant with a history of congenital heart disease who received the GSK RSV vaccine in combination with routine childhood vaccinations. That child required hospitalization for cardiorespiratory arrest within 24 hours after vaccine receipt. The remaining six reports described injection site reactions or systemic reactions, such as irritability, after receiving the RSV vaccines.
"Administration errors are preventable with proper education and training," the authors of the report emphasized. They suggested several strategies to prevent vaccine administration errors, including only ordering products that are approved for the patient population a facility serves, electronic health record alerts or warnings, close attention to labeling, and best practices for vaccine storage.
"To prevent mix-ups, CDC reached out to clinicians to educate them about the proper administration of the RSV vaccines," Moro said. "Education and additional vigilance will reduce the likelihood of errors."
The CDC and FDA will continue to monitor VAERS for vaccine administration errors, and clinicians are encouraged to report errors to VAERS.
The report was published several months after a notice was sent to healthcare providers that the CDC and FDA had received reports of 25 cases of the RSV vaccines being administered in error to young children in outpatient settings. At that time, there were also 128 reports of the GSK RSV vaccine being administered in error to pregnant people in outpatient settings and pharmacies. However, the CDC noted that, overall, these were a small number of cases relative to an estimated 1 million infants protected from RSV either through vaccination of pregnant individuals or infant receipt of nirsevimab -- a monoclonal antibody recommended for all infants under 8 months of age entering their first RSV season or born during it.
In instances when an RSV vaccine is given in error to children, no special monitoring is needed, according to the CDC. However, because the efficacy of the adult RSV vaccines in infants and young children has not been evaluated, children who receive an RSV vaccine in error should receive nirsevimab to prevent severe RSV disease, if otherwise eligible.
Disclosures
Moro and other study co-authors reported no potential conflicts of interest.
Simões reported consulting for GSK and has received grants for research and consulting from Pfizer.
Primary Source
Pediatrics
Source Reference: Moro PL, et al "Incorrect administration of adult RSV vaccines to young children" Pediatrics 2024: DOI: 0.1542/peds.2024-066174.
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