More than 30 Babies Mistakenly Vaccinated with Pfizer or GSK’s RSV Shots

At least 34 babies were mistakenly given the RSV vaccine and one of those babies…

Children's Health Defense

At least 34 babies were mistakenly given the respiratory syncytial virus (RSV) vaccine and one of those babies was hospitalized according to a study published today in Pediatrics.

Researchers from the Centers for Disease Control and Prevention (CDC) analyzed data from the Vaccine Adverse Event Reporting System (VAERS) for the RSV vaccines, which are not approved for children.

The researchers found 27 reports of the Pfizer RSV vaccine (Abrysvo) and seven reports of the GSK RSV vaccine (Arexvy) mistakenly administered to children under 2 between Aug. 21, 2023, and March 18, 2024.

“While rare, vaccine administration errors are known to occur and may increase after a new vaccine or product is introduced,” Dr. Pedro Moro, lead author of the study, told MedPage Today.

Both vaccines were first approved in May 2023 for people ages 60 and older. Pfizer’s Abrysvo was approved in August 2023 for pregnant mothers during part of their third trimester, targeting RSV prevention in babies.

Thirty-one of the babies identified in the study who were mistakenly vaccinated were less than 8 months old. Seven reports described adverse health events including fevers, vomiting, coughing and injection site swelling.

One baby was hospitalized for cardiorespiratory arrest within 24 hours of receiving the GSK RSV vaccine. The baby had a history of congenital heart disease and was hospitalized at the time of the VAERS report.

VAERS also contains at least one report of a 27-day-old baby who died in the doctor’s office immediately after receiving Pfizer’s RSV vaccine, but that report was not included in the Pediatrics study.

The Defender, which reported on the death in March, worked with data analyst and VAERS expert Albert Benavides to identify several instances in the VAERS database of severe adverse events in newborns, in pregnant women and people in age groups for which the RSV vaccines were not approved.

Moro did not immediately respond to a question from The Defender about why the study did not mention this report.

The Pediatrics study authors identified the cases by searching VAERS for children younger than 2 who received an RSV vaccine and by doing a text search using keywords such as “infant,” “child,” “newborn,” and others, which they said was conducted consistent with CDC policy.

Benavides told The Defender identifying all of the cases associated with a given drug is challenging. For example, he said approximately 25% of VAERS entries have no age data, so one has to read the narrative summaries to find that information.

The VAERS database is a passive surveillance system where anyone — including doctors, other vaccine administrators and the public — can report adverse events. The public health agencies monitor the system to detect safety signals associated with vaccines. The signals are then subject to further investigation.

The Pediatrics researchers noted that the major limitation of their study is that VAERS has under- and over-reporting biases and inconsistency in the completeness of reports.

“Health care providers should not administer Pfizer or GSK RSV vaccines to infants and young children,” the study authors said in their discussion. They noted that administration errors are preventable with proper training.

Today’s report was published a few months after the CDC notified providers in January about 25 reports that Pfizer and GSK’s RSV vaccines had been mistakenly administered to infants and 128 reports that GSK’s vaccine — which is not approved for pregnant women — was mistakenly given to them.

Most VAERS reports analyzed did not explain the error. Two noted they were administered by a new staff member and one said it was given because nirsevimab, a monoclonal antibody treatment for RSV approved for young children, was out of stock..