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

FOIA documents obtained by Children’s Health Defense reveal that two infants died the same day they received nirsevimab, a monoclonal antibody shot approved last year for infants.

by Brenda Baletti, Ph.D.

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.

For example, even people at the CDC in internal emails referred to the monoclonal antibodies as the “RSV (Sanofi Pasteur) Vaccine.”

Data analyst and VAERS expert Albert Benavides told The Defender this also presents a challenge to people who want to report nirsevimab injuries, because VAERS does not have a category for the drug, so people have submitted their claims as “unknown vax type” or selected one of the existing RSV vaccines, which are different drugs.

In analysis, they may fall through the cracks or be underreported, rather than forwarded to the FDA’s MedWatch system.

The emails obtained by CHD support Benavides’ claims that there is confusion between RSV vaccines approved for adults and RSV monoclonal antibodies approved for infants.

For example, Carol Ennulat, VAERS project coordinator, on March 21 emailed Pedro Moro, M.D., M.P.H, who headed up the accidental infant RSV vaccination study, informing him that one of the infants — a 1-month-old girl in Texas — died after receiving the “RSV (Sanofi Pasteur) Vaccine,” which is actually Beyfortus, the monoclonal antibody.

She told Moro the baby had been misclassified and therefore mistakenly assigned to the adult RSV project.

Moro forwarded the email to others and said the FDA was following up on nirsevimab reports, so they should take no action on the report.

In a second email the following day, Ennulat informed Moro that a second infant death — a 27-day-old New York boy — was misclassified as having received the Pfizer Abrysvo vaccine according to documents that had become available.

“The case was misclassified,” Ennulat wrote. Although the sentence indicating what drug he received was redacted, she added, “I assume FDA follows this,” which would indicate the drug administered to the infant and then reported to VAERS was likely also nirsevimab.

500 pages of FOIA documents largely redacted

CDC researchers in May published an article in Pediatrics reporting that at least 34 babies were mistakenly given the RSV vaccine — made by either Pfizer or GSK and authorized for adults — and one of those babies was hospitalized.

Thirty-one of the children under age 2 identified in the study who were mistakenly vaccinated between Aug. 21, 2023, and March 18, 2024, 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.

When the paper was published, The Defender worked with Benavides and identified at least two other babies in the VAERS system reported to have received the RSV vaccine and died within hours of vaccination.

The Defender reached out to the CDC in a series of emails inquiring about why the babies were not included in the study, but the CDC declined to provide details about its knowledge of the reports.

The agency said only that the VAERS reports were mistaken — neither infant had received the shot.

In response, CHD filed FOIA requests with the CDC for communications related to the two reports.

The CDC recently responded to the request, sending 556 pages of largely redacted response materials. Redactions included portions of emails sent by The Defender to the CDC and the agency’s responses — which CHD clearly already had in its possession.

Two largely unredacted emails included in the documents, however, did pertain to the babies’ deaths.

No mention of infant deaths in CDC advisory committee meeting

In the last research presentation session of the June 26-28 meeting of the CDC’s vaccine advisory committee, the RSV work group presented data on nirsevimab, touting its effectiveness — how well it prevents disease under real-world conditions — with limited discussion of safety issues.

The CDC reported in the presentation that 41% of eligible infants received the nirsevimab shot as of March 2024, 24% of parents indicated they would definitely get the shot for their children and 23% indicated they would probably get it or were unsure. Twelve percent indicated they would never give their children the shot.

The agency also said it was meeting with manufacturers to ensure they would ramp up production for the coming year after shortages of the drug were reported last year.

The committee presented a range of different effectiveness numbers from different observational studies. Overall, real-world data found the shot was “well above 50%” effective against RSV infection. Committee members said this corresponded to the European published literature that found effectiveness against hospitalization of 70-89% and against emergency room visits of 55-88%.

They said observational data showed the duration of protection was unknown.

In the presentation on nirsevimab safety, the CDC’s Dr. Jefferson Jones informed the committee that VAERS is not the primary system for monitoring the drug’s safety, because it is not a vaccine, so the data had not been previously presented. Instead, he said, adverse events should be reported to MedWatch.

Same-day events are reported to VAERS, he said, and then reviewed by the FDA.

He did, however, review the adverse events reported to VAERS.

Jones said the most frequently reported adverse events were RSV breakthrough infections. He also said, “Cases of serious hypersensitivity reactions with nirsevimab were identified and the product labeling was updated in February 2024” to indicate that.

The reactions include hives, shortness of breath, low blood oxygen levels causing blue skin, lips and nailbeds and muscle weakness. “And no additional safety signals have been identified at this time,” he said.

Jones did not mention the two infant deaths that the FOIA documents obtained by CHD reveal happened immediately following the shots.

The committee did emphasize several times that newborn deaths reported to VAERS “is of course devastating for that family, but reporting to VAERS does not necessarily mean that vaccine caused that.”

However, in that case, they were discussing neonatal death associated with the maternal RSV vaccine.

Jones concluded that the RSV work group was “very happy and pleased with the evidence that shows nirsevimab to be highly effective.”

Known safety Issues with nirsevimab/Beyfortus

RSV is a common respiratory virus that usually causes mild cold-like symptoms but can lead to hospitalization and, in rare cases, death in infants and the elderly.

By age 2, 97% of all babies have been infected with the RSV virus, which confers partial immunity, making any subsequent episodes less severe.

Yet last year as the media hyped a dangerous “tripledemic” of COVID-19, flu and RSV, new RSV vaccines were approved and recommended for pregnant women and older adults, and nirsevimab was approved for infants.

The Biden administration rushed to work with Sanofi and AstraZeneca to make hundreds of thousands of doses of the antibodies available.

According to the CDC, approximately 58,000 to 80,000 children younger than age 5 are hospitalized due to RSV infection annually and 100 to 300 deaths occur annually in that group.

Those numbers are also disputed within the CDC’s own data.

In an Aug. 4, 2023, Substack post, Dr. Meryl Nass, an internist and biological warfare epidemiologist, cited 2021 CDC data showing that over 12 years, on average 25 babies up to age 1 die annually in the U.S. from RSV.

Although RSV can be a serious event for infants, with so few deaths among that age group, both researchers and practitioners have raised questions about administering vaccines to pregnant mothers and monoclonal antibodies to babies, especially given the serious risks evident in clinical trials, and now, in post-trial follow-up.

According to the Cleveland Clinic, reactions to monoclonal antibody treatments are common and occur during or shortly after they are administered. There are also “more serious but less common risks linked to unwanted immune system reactions, such as acute anaphylaxis, cytokine release syndrome (CRS) and serum sickness.”

Nass noted that no monoclonal antibody product has ever been given on a mass scale to children. She also said that the Beyfortus label doesn’t provide information about side effects and don’t address the infant deaths in the clinical trials.

Of the 12 infants that died in the nirsevimab trials, “four died from cardiac disease, two died from gastroenteritis, two died from unknown causes but were likely cases of sudden infant death syndrome, one died from a tumor, one died from Covid, one died from a skull fracture and one died of pneumonia,” CNBC reported.

“Most deaths were due to an underlying disease,” the FDA’s Dr. Melissa Baylor said.

According to the drug’s label, no drug interaction studies — that, for example, might identify safety risks if the antibodies are given with other vaccines — have been done for Beyfortus.

Researchers have been trying and failing to develop an RSV vaccine for children for 60 years, but have encountered serious safety issues. One version developed in the 1960s worsened symptoms for children. In that case, when two infants died, the vaccine distribution was stopped.

Beyfortus is being promoted for babies by governments globally, particularly in Europe, where it was first approved in November 2022.

French independent scientist and author Hélène Banoun, Ph.D., and French statistician Christine Mackoi found that data from France’s National Institute of Statistics and Economic Studies indicates an improbably high rate of deaths of babies between 2 and 6 days old in France during September and October 2023.

Those dates correspond with the introduction of Beyfortus in French hospitals, which began on Sept. 15, 2023, The Defender reported.

Beyfortus costs $519.75 per dose for 50-milligram (mg) and 100-mg doses and $1,039.50 for a 200-mg dose. That doesn’t include administration costs.