RSV Shots Added to the Childhood Vaccine Schedule

CDC Promotes Another Ineffective Jab

In August 2023, CDC recommended a new respiratory syncytial virus (RSV) vaccine (their term) called nirsevimab (brand name Beyfortus™) to protect babies and some toddlers from severe RSV during the RSV season. By adding nirsevimab to the Childhood Vaccine Schedule, CDC guarantees co-developers AstraZeneca and Sanofi both profits and blanket liability protection.

But what do children get?

First, a little background on RSV.

RSV is a common, highly contagious, seasonal respiratory virus that typically causes a mild, cold-like illness. RSV season usually starts in fall and peaks in mid-winter. Around 97% of children will have contracted the disease by the time they are 2 years old.

Occasionally, RSV produces a lower respiratory tract infection associated with bronchiolitis and pneumonia in infants. Bronchiolitis is an infection of the small airways called bronchioles that can swell and become plugged with mucus. RSV is also a common cause of otitis media (inner ear infection).

RSV is the leading cause of hospitalization in infants. An estimated 58,000-80,000 children younger than 5 years are hospitalized due to RSV infection each year, or about 4 per thousand children. Hospitalized children who are otherwise healthy have a survival rate of around 99%, but 100 to 300 die each year.  Children with suppressed immunity have a much higher mortality rate.

So practically all kids catch RSV as infants and most do just fine.  Some children, even healthy ones, go on to get more severe disease and be hospitalized.  It would be nice to prevent severe infections leading to hospitalization.

The only problem is that nirsevimab therapy (not a vaccine, which we explain later) clinical trials never achieved statistical significance for preventing hospitalization, much less death.  The therapy did reduce the incidence of RSV lower respiratory tract infection for which medical attention was provided, but these cases were managed as outpatients and never needed admission to a hospital.

Not a Vaccine

Nirsevimab is a monoclonal antibody therapy, which is an immunoglobulin (immune cell) with anti-RSV activity.  It is produced by recombinant DNA technology and works by interfering with RSV’s ability to bind to cells and infect them.

Before September 1, 2021, according to the CDC the definition of vaccine was,

A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.

After that date, the CDC changed the definition to,

A preparation that is used to stimulate the body’s immune response against diseases.

Nirsevimab is not a vaccine under either definition.

It does nothing to stimulate the body’s immune response. In fact, the monoclonal antibody was submitted for approval to the FDA under a Therapeutics Biologic License Application (BLA) as a therapeutic, not a vaccine.  As a therapeutic, nirsevimab broke long-standing precedent when it was added to the vaccine schedule. According to Johns Hopkins School of Public Health,

Nirsevimab is not a vaccine. It’s a preventive drug that offers passive immunity. Monoclonal antibodies work by providing immediate and short-term protection, whereas vaccines ‘boost your immunity in the future.’

The addition of nirsevimab to the Schedule assures the cost of the drug will be covered by the federal Vaccines for Children Program and the manufacturer has blanket protection from liability. No other therapeutic enjoys such a guaranteed income stream or liability protection.

Safety

As therapeutics, monoclonal antibodies are intended to treat specific diseases or conditions. For example, monoclonal antibodies have been used to treat COVID-19, as well as certain autoimmune disorders and cancers. However, their use as a preventive therapy for a specific infection such as RSV is unprecedented.

The maximum period for follow-up during nirsevimab clinical trials was one year and limited to a couple of thousand children.  Long term effects on millions of children’s immunological and other developing systems are simply unknown.

The injection of foreign proteins in the form of monoclonal antibodies into humans of any age is known to have significant side effects. According to the Cleveland Clinic,

Infusion reactions are common after monoclonal antibody treatment. Common signs of infusion reaction are rash, fever, rigor/chills, shortness of breath, changes in blood pressure and increased heart rate. More serious but less common risks [are] linked to unwanted immune reactions such as anaphylaxis, cytokine release syndrome and serum sickness.

Another challenge: antidrug antibodies were detected in over 6% of infants who received nirsevimab. This means that the child’s immune system was rejecting the antibodies and thereby decreasing their concentration.  Two of the 12 infants (16.6%) in the treatment group who had severe respiratory infections had antidrug antibodies.

Oh, and it should be noted that the clinical trials were paid for by the vaccine’s developers, AstraZeneca and Sanofi.

Summary

RSV is a common childhood illness, with a low incidence of severe illness and hospitalization for healthy children. For healthy kids who do require hospitalization, supportive care yields high survival rates and limited hospital stays.

Clinical trials show no evidence for reduction in hospitalization or mortality, the very reasons for which mass distribution and use of nirsevimab has been promoted.

Nirsevimab is approved as a therapeutic, not a vaccine. The addition of a therapeutic to the Childhood Vaccination Schedule is unprecedented.  Clinical trials prior to FDA approval involved relatively small test groups and limited follow up compared with most therapeutics.  Placing nirsevimab on the Schedule will expose millions of children to the therapy and its potential risks, the vast majority of whom will otherwise suffer mild to no ill effects from RSV infection.