CDC Reports Errors in RSV Vaccine Administration

This fall marked the debut of immunizations to prevent RSV in high-risk groups: older adults, pregnant people, and young children. While the rollout has been plagued with shortages from the start, the Centers for Disease Control and Prevention (CDC) recently called attention to a new issue: Some RSV vaccine recipients received a shot intended for a different group.

In roughly 128 instances, pregnant people were mistakenly administered a vaccine that’s only approved for adults 60 and up. In about 25 cases, children under 2 years old received a vaccine only approved for adults.

The news was delivered to clinicians via a CDC clinician announcement, said Ann Philbrick, PharmD, associate professor at the University of Minnesota College of Pharmacy, told Verywell.

Currently, there are two RSV vaccines: Abrysvo (made by Pfizer) and Arexvy (made by GSK). Both are FDA-approved for people over the age of 60, and Abrysvo is also approved for pregnant people between 32 and 36 weeks gestation. A monoclonal antibody immunization called Beyforus (made by Sanofi and AstraZeneca) is approved for use among babies entering their first RSV season and children up to 2 years of age.

The healthcare facilities that made the errors reported them to the Vaccine Adverse Event Reporting System (VAERS), which is monitored by the FDA and CDC. Most of the error reports described no adverse events, meaning most patients did not have a serious reaction.

The CDC, FDA, and other federal agencies are continuing to monitor the safety of RSV vaccines and following up with affected patients more closely.

How the Errors Happened

The errors mainly occurred in doctor’s offices and pharmacies.

“I would surmise it was a combination of all three products being released in short succession of each other and lack of knowledge of the specifics of each product,” Philbrick said.

Vaccine errors are rare, Steve Grapentine, PharmD, BCPS, a pediatric infectious disease pharmacist at UCSF Benioff Children’s Hospital, told Verywell. He recommends that patients request to view the label of the product being administered or double-check with the provider or pharmacist administering the vaccine. 

“These errors were unfortunate, but they do provide an important learning opportunity for those that provide vaccines,” Philbrick said. “Locally, whichever healthcare facility made the error will hopefully review all steps of their process to try to mitigate the chances of repeating the error, though they are not mandated to do so.”

What to Do If You Got the Wrong Vaccine 

Your provider is required to make you aware of any vaccine administration errors they learn about.

If you believe you’ve received the wrong vaccine, report it to your primary healthcare provider and monitor for any serious reactions, including but not limited to mild fever or severe muscle soreness.

“If a serious reaction were to occur, that would likely happen within the first 15 minutes after vaccine administration,” Grapentine explained. Most other reactions happen in the first 24 hours. “Fortunately, most vaccines are well-tolerated even when given incorrectly.”

Though nobody experienced severe side effects from this mixup, experts don’t think the RSV vaccines will become interchangeable among the different high-risk groups any time soon.

“None of these products are interchangeable,” Grapevine said. “Arexvy and Abrysvo are each dosed in micrograms and technically contain the same amount of RSV vaccine, but you cannot make direct comparisons between the two. Vaccine and medication strengths are unique to that specific product. Beyfortus is dosed in milligrams and not technically a vaccine, so it’s even more different.”