Exclusive: Two Infants Died Within Hours of Receiving RSV Shots, CDC Internal Emails Show

Freedom of Information Act documents obtained by Children’s Health Defense reveal that two infants died…

Children's Health Defense

At least two infant deaths reported to the Vaccine Adverse Event Reporting System (VAERS) as occurring after the babies mistakenly received Pfizer’s adult respiratory syncytial virus (RSV) vaccine were likely caused instead by nirsevimab, the monoclonal antibody shot approved for infants and meant to prevent RSV.

Freedom of Information Act (FOIA) documents obtained by Children’s Health Defense (CHD) from the Centers for Disease Control and Prevention (CDC) show that both babies died on the day they received the shots.

According to the reports in VAERS, a 27-day-old boy died immediately upon receiving the shot in the doctor’s office and an infant girl was found not breathing by her father seven hours after receiving the shot. The infant was pronounced dead soon after.

The deaths were reported in VAERS as resulting from mistaken administration of Pfizer’s adult RSV vaccine, but the CDC internal emails obtained by CHD indicate the babies had been administered Beyfortus, the brand name for nirsevimab, manufactured by AstraZeneca and Sanofi.

The U.S. Food and Drug Administration (FDA) approved the drug in July 2023 and the CDC recommended it in August 2023 for infants under 8 months or high-risk infants up to 24 months of age.

In clinical trials for the drug, 12 infants died, but an FDA spokesperson told CNBC when the drug was approved that “none of the deaths appeared to be related to nirsevimab.”

After the CDC recommended the drug, it expanded the 2024 childhood vaccine schedule and included nirsevimab for infants whose mothers did not receive the RSV vaccine — also recently approved — during pregnancy.

The CDC’s childhood immunization schedule lists the CDC-recommended shots for children from birth through age 18. Pediatricians and other clinicians typically use the schedule to make recommendations to parents, and schools use it to set vaccine requirements.

Monoclonal antibodies are not technically vaccines. Vaccines stimulate the individual’s immune system to trigger an immune response. Monoclonal antibodies are proteins cloned in a lab that act like antibodies, seeking out antigens in the body to destroy them just like people’s own antibodies do, according to the Cleveland Clinic.

When the CDC expanded the 2024 vaccine schedule, it changed the description of the schedule to be for “vaccines and other immunizing agents,” before adding the RSV monoclonal antibodies to the list.

Even professionals confused about how to report injuries related to infant RSV shots

When people experience vaccine injuries, they can report them to the CDC using VAERS, a passive surveillance system available to anyone — including doctors, other vaccine administrators and the public — for reporting adverse events.

The CDC also has other systems for monitoring vaccine safety. It monitors COVID-19 and adult RSV vaccines through the V-safe system, a different voluntary reporting system, and most vaccines through the Vaccine Safety Datalink (VSD), which analyzes healthcare data, often investigating concerns initially raised in VAERS.

However, according to the internal emails obtained by CHD, and reported by the CDC to its advisory committee, the CDC doesn’t monitor injuries from medications that are not vaccines. The FDA recommends those injuries be reported to MedWatch, the FDA’s adverse event reporting system.

That means adverse events from all medical treatments on the immunization schedule are not monitored through the same system. This can generate confusion, even among medical professionals, who treat monoclonal antibodies as vaccines…