Wrong RSV Vaccines Given to Some Pregnant Women and Children, CDC Warns

Federal health officials are warning that certain individuals who face an increased risk of developing severe respiratory virus infections have received the wrong vaccine to protect them.

The U.S. Centers for Disease Control and Prevention (CDC) issued the warning on January 22, indicating at least 128 pregnant women and at least 25 children under the age of two were given a respiratory virus vaccine that was not recommended or suitable for their specific population group.

Respiratory Syncytial Virus (RSV) is a common virus that causes infections of the respiratory tract. It normally causes cold-like symptoms and healthy individuals usually recover within a week or two. However, infants, pregnant women, older adults, and those with weakened immune systems are more likely to develop serious RSV complications that require hospitalization, including severe lung inflammation, bronchiolitis, pneumonia, and respiratory failure.

The first RSV vaccines were introduced in 2023 to protect vulnerable populations prone to developing severe lower respiratory tract complications associated with the virus. Three different vaccines were released within just months of each other last year, and were approved for different population groups. This may have led to confusion among medical professionals, and resulted in the influx of recent vaccine errors, the CDC indicates.

RSV Vaccines Administered in Error

Officials recommended Beyfortus (Nirsevimab) for infants younger than eight months of age, and for certain children up to 19 months old, who are at an increased risk of developing severe RSV. Abrysvo was introduced as the only RSV vaccine recommended for pregnant women, and for adults 60 or older, but was not approved for use in infants or young children. Arexvy was recommended for use in adults over the age of 60, but was not approved for use in pregnant women, infants, or young children.

Following approval of the RSV vaccines, the CDC reports that officials have received 128 reports of pregnant women being administered the Arexvy vaccine recommended for adults over 60 years of age in error, and 25 reports of children under two years of age receiving the Abrysvo or Arexvy vaccines by mistake, which were only recommended for adults.

According to the warning, most of the vaccine administration errors occurred in infants younger than eight months old. Many of the errors happened in outpatient facilities, including doctor’s offices, but they were also reported among pharmacies.

The CDC indicates most of the individuals did not experience any adverse reactions after receiving the wrong vaccine, and any that were reported were not serious in nature.

Officials will continue to monitor reports of RSV vaccine administration errors, and will notify the public when more information is available.

CDC Recommendations to Healthcare Providers

The CDC recommends infants or young children who should have received the Beyfortus (Nirsevimab) RSV vaccine but were given the Abrysvo or Arexvy vaccines in error, should be given a dose of Beyfortus.

Pregnant women who received the Arexvy vaccine in error should not be given the Abrysvo vaccine they were initially recommended to receive. Healthcare providers should administer the Beyfortus (Nirsevimab) vaccine to their infant during RSV season instead, if they are under eight months old.

Medical professionals and facilities are urged to ensure they administer the correct RSV vaccine recommended for the patient’s population group. The CDC also urges them to implement automated error prevention alerts in health record systems, vaccine recommendation education and training, follow proper vaccine storage and administration practices, and pay close attention to vaccine labels to prevent further administration errors.

Providers can email their questions regarding vaccine administration errors to NIPINFO@cdc.gov. Those who have more complex questions, or those who would like to request consultation on a vaccine error for a specific patient can submit their requests to the Clinical Immunization Safety Assessment (CISA) Project.

The CDC encourages healthcare providers to report any errors in administering vaccines to the Vaccine Adverse Event Reporting System (VAERS).