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As if adding COVID-19 vaccines to the immunization schedule for infants as young as 6 months of age wasn’t enough, the Centers for Disease Control and Prevention (CDC) added yet another novel immunization babies are expected to receive this fall.

The CDC on August 3 signed off on a controversial new immunization they say will protect infants under 8 months of age and some older babies at a higher risk of severe illness caused by respiratory syncytial virus (RSV).

RSV is a common respiratory virus that almost all babies encounter by the time they reach two years of age. Although it can result in hospitalization, the virus usually causes mild, cold-like symptoms babies recover from within a week.

CDC director Dr. Mandy Cohen approved recommendations made by its Advisory Committee on Immunization Practices (ACIP) to add nirsevimab, also known as Beyfortes, to the childhood vaccine schedule based on data from a non-peer-reviewed study sponsored by the manufacturer showing 12 infant deaths during the clinical trial.

“This new RSV immunization provides parents with a powerful tool to protect their children against the threat of RSV,” said Cohen in a press release. “RSV is the leading cause of hospitalizations for infants and older babies at higher risk, and today we have taken an important step to make this life-saving product available.”

The CDC recommends one dose of nirsevimab for all infants younger than 8 months, born during or at the start of their first RSV season—typically fall through spring—and for a small subset of children between 8 and 19 months of age.

The CDC claims the monoclonal antibody drug will reduce the risk of hospitalization and doctor visits for RSV in infants by 80%. However, clinical trial data shows the drug, at most, was only 75% effective at preventing lower respiratory tract infections that required medical attention and up to 78% effective at preventing hospitalization.

Additionally, any protection provided by the immunization is only good for up to five months, so it doesn’t protect children from RSV during the entire two-year window they’re most likely to be exposed to the virus, and may cause both short-term and long-term side effects that are entirely unknown.

FDA and CDC Ignore 12 Infant Deaths Reported During Clinical Trial

The CDC’s decision came less than two weeks after the FDA approved nirsevimab, with no research showing how monoclonal antibody products affect infants or the safety of injecting babies born to women who received an RSV vaccine during pregnancy.

The FDA and CDC admitted there was “an imbalance of deaths” between those who received nirsevimab and the control but determined the deaths were “unlikely to be related to nirsevimab.”

Twelve babies died during the clinical trial, including four babies who died from cardiac disease, two from gastroenteritis, two from unknown causes but were likely cases of sudden infant death syndrome, one from a brain tumor, another from a skull fracture, and one death from pneumonia.

The FDA said the most commonly reported adverse events were reactions at the injection site and rashes. The product label for Beyfortus only mentions rashes and anaphylaxis. It does not reference any potential severe reactions that could result from monoclonal antibody treatments, nor does it reference the 12 deaths that occurred during the clinical trial.

The label also states that “carcinogenesis, mutagenesis, and reproductive toxicity studies have not been performed with Beyfortus” and that “no formal drug interaction studies have been performed” with the drug. There is also “limited experience with co-administration of Beyfortus with vaccines.”

This is highly concerning because infants are given numerous vaccines during their first eight months of life.

CDC Uses Definition of Vaccine to Benefit Drug Maker

Nirsevimab will be distributed under the brand name “Beyfortus” and is manufactured by AstraZeneca and marketed by Sanofi. It will also enjoy the benefits of being a drug and a vaccine, despite the fact it is not a vaccine.

Nirsevimab is a monoclonal antibody product that passively immunizes infants with antibodies made in a lab, which makes it a drug. Vaccines are designed to train the body’s immune system to release antibodies that fight viruses, whereas nirsevimab injects antibodies directly into the bloodstream.

Although nirsevimab is classified as a therapeutic drug, the CDC is also allowing it to enjoy the benefits of being classified as a vaccine so that it can be added to the immunization schedule and placed in the Vaccines for Children program, which covers the cost of vaccines for uninsured children.

Since some states place restrictions on injectable drugs, classifying nirsevimab as a vaccine allows it to get around those rules, as well as potential coding, tracking, and billing issues. The classification will also allow the manufacturer to enjoy special liability protections.

In justifying the mixed classification as vaccine and drug, Dr. Georgina Peacock, with the CDC’s National Center for Immunization and Respiratory Diseases, said during the August meeting:

“When we look at the Vaccines for Children program, there is no statutory definition of vaccine in the statute when we look at the Affordable Care Act. Similarly, there is no statutory definition of vaccine in the Affordable Care Act,” so the “CDC has determined that [Beyfortus] is eligible for inclusion in the childhood immunization schedule and the Vaccines for Children program.”

Peacock said Beyfortes is similar to other routine vaccines, is stored and handled like a vaccine, is administered intramuscularly, and can be administered with other pediatric vaccines.

The Affordable Care Act will cover Beyfortes as a vaccine, but adverse events experienced when the drug is used alone will be reported to the FDA’s Adverse Event Reporting System. If administered with other vaccines, it will be reported to the Vaccine Adverse Event Reporting System known as VAERS, where it will be impossible to determine whether a co-administered vaccine or nirsevimab caused the adverse event.

At the same time, the National Vaccine Injury Compensation Program, which covers injuries related to routine childhood vaccinations, will conveniently not apply to Beyfortes.

The Bottom Line

At the end of the day, nirsevimab has not been proven safe or effective and has yet to be subjected to any long-term clinical trials or independent studies by institutions other than the manufacturer who stands to profit from its widespread use.

At least 12 deaths occurred during the clinical trial and were not taken seriously. The protection given, if any, will last no longer than five months. Very few infants die from RSV in the U.S., and short-term and long-term side effects of the drug are entirely unknown—as are the risks of using this drug with co-administered vaccines.

It would appear U.S. regulatory agencies are, once again, catering to pharmaceutical companies who benefit from hybrid classifications and liability protections at the expense of ensuring the benefits outweigh the risks of yet another novel product soon to be distributed widely to the nation’s youngest children.

Megan Redshaw

Megan Redshaw

Megan is an attorney and journalist with additional expertise in natural health. She has a flare for breaking down complex and controversial topics into easy-to-synthesize and entertaining pieces that empower others to make informed decisions.

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