Worth the Risk? RSV Shots for Babies Lack Long-term Safety Data

Written by Joseph Mercola on September 5, 2024. Posted in Current News

Story at a glance:

• Nirsevimab, a new respiratory syncytial virus (RSV) shot for infants, has raised safety concerns after reports of infant deaths following administration.

• The reporting system for adverse events is unclear, potentially leading to underreporting.
• Unlike conventional vaccines, nirsevimab is a monoclonal antibody. Its widespread use in children is unprecedented, and long-term safety data is limited.
• Clinical trials showed an imbalance in deaths between treatment and placebo groups. The U.S. Food and Drug Administration (FDA) deemed these unrelated to nirsevimab, but questions remain about this conclusion.
• There are concerns about antibody-dependent enhancement (ADE), where antibodies may enhance viral infection. This risk could increase as antibody levels wane over time.
• The cost-effectiveness of mass nirsevimab administration is questionable. Real-world data shows many vaccinated infants are still being hospitalized for RSV, and resistant strains are emerging.

Freedom of Information Act (FOIA) documents obtained by Children’s Health Defense reveals a disturbing development surrounding the new RSV shot for infants, nirsevimab (brand name Beyfortus).

Nirsevimab is being promoted as a breakthrough in protecting babies from RSV. However, there are serious concerns about its safety that you should be aware of before consenting to this treatment for your child.

At least two infant deaths reported to the Vaccine Adverse Event Reporting System (VAERS) were likely caused by nirsevimab, not the adult RSV vaccine as initially thought.

Both babies died on the same day they received the shots. One 27-day-old boy died immediately in the doctor’s office, while an infant girl was found unresponsive seven hours after injection.

These tragic events highlight the potential risks associated with nirsevimab administration to young infants. It’s crucial to note that during clinical trials, 12 infants died, though officials claimed these deaths were unrelated to the drug.

There was no mention of these post-market fatalities at the U.S. Centers for Disease Control and Prevention’s (CDC) June advisory committee meeting, raising questions about transparency in safety reporting.

As a parent, you should be aware that even medical professionals seem confused about how to properly report adverse events related to nirsevimab, potentially leading to underreporting of serious side effects.

Nirsevimab RSV shot is not a vaccine — it’s a monoclonal antibody

The U.S. Food and Drug Administration (FDA) approved nirsevimab for RSV prevention in infants in July 2023. In August 2023, the Advisory Committee on Immunization Practices recommended nirsevimab for all infants under 8 months old born during or entering their first RSV season.

It’s also recommended for some children between 8 and 19 months old who are at high risk for severe RSV disease and entering their second RSV season.

However, the introduction of nirsevimab has exposed significant gaps in the adverse event reporting system for non-vaccine shots. Unlike conventional vaccines, nirsevimab is a monoclonal antibody, which falls into a different category for safety monitoring.

A monoclonal antibody provides passive immunity by directly supplying antibodies to fight a specific pathogen. In contrast, a vaccine stimulates your body’s immune system to produce its own antibodies, creating active immunity that develops over time.

The CDC doesn’t directly monitor injuries from medications that are not vaccines, instead relying on the FDA’s MedWatch system. This discrepancy has led to confusion among healthcare providers and the public about where and how to report side effects.

Albert Benavides, a data analyst and VAERS expert, 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.”

This confusion could result in the underreporting of adverse events and make it more difficult to accurately assess the safety profile of nirsevimab. Parents should be aware that this reporting inconsistency might mask risks associated with the drug.

Long-term safety concerns and economic implications

The rush to implement widespread nirsevimab use raises questions about long-term safety and economic feasibility. Dr. Meryl Nass, an internist and biological warfare epidemiologist, points out that no monoclonal antibody product has ever been given on a mass scale to children before.

The safety profile of nirsevimab raises significant questions. While the product label mentions only rashes and anaphylaxis as potential risks, this appears to be a remarkably uninformative description.

Nass points out that monoclonal antibodies are associated with numerous side effects, from changes in blood pressure and increased heart rate to cytokine release syndrome.

More alarmingly, Nass says, there was an “imbalance” in deaths between the treatment and placebo groups during clinical trials.

The FDA reportedly “judged” that these excess deaths were not due to the monoclonal antibody, but it’s unclear how they reached this conclusion without more comprehensive safety data.

The lack of detailed information about side effects and causes of death in newborns is extremely concerning.

But this product is being recommended for widespread use despite these unresolved safety issues — and carcinogenesis, mutagenesis and reproductive toxicity studies have not been performed.

The price of nirsevimab is also substantial, Nass notes, with the CDC paying $395 per dose for 0- to 8-month-olds and other buyers paying $495. For older infants (8-19 months), the price doubles.

Despite this high cost, there are already concerns about its long-term effectiveness. RSV strains resistant to nirsevimab have been identified, suggesting that widespread use could lead to ecological changes in RSV populations.

As resistant strains outcompete susceptible ones, the product’s efficacy may diminish rapidly. This raises questions about the wisdom of implementing such an expensive intervention that may have a limited useful lifespan.

Regulatory classification and liability considerations

Nirsevimab occupies a curious position between drug and vaccine classifications. The CDC appears to be using these definitions interchangeably when convenient.

By calling it a vaccine, manufacturers can obtain liability protection through inclusion in the childhood vaccine schedule. However, for reimbursement purposes, it’s coded as a drug.

This dual classification also affects adverse event reporting: when used alone, reports go to the FDA’s drug system (FDA Adverse Event Reporting System, or FAERS).

But when administered with other vaccines, reports are sent to VAERS. This regulatory ambiguity only further complicates safety monitoring and accountability.

The hidden dangers of antibody-dependent enhancement

One of the most worrying risks of the RSV shot, as noted in a preprint study by French scientist Hélène Banoun, Ph.D., is antibody-dependent enhancement (ADE).

This phenomenon occurs when antibodies actually help a virus infect cells more easily instead of neutralizing it. ADE has been observed with other respiratory viruses and vaccines, and it’s a theoretical risk with nirsevimab as well.

Banoun told The Defender that, in France, “A significant increase in mortality among newborns between 2 and 6 days of age was observed from the start of the [RSV shot] campaign: babies were injected before leaving the maternity ward.”

The shot works by providing antibodies that target the RSV fusion protein. These antibodies have been engineered to last longer in your baby’s body, with a half-life of 80 to 120 days. But this modification could potentially increase the risk of ADE as antibody levels gradually decline over time.

At low concentrations, the antibodies might not be able to fully neutralize the virus, instead facilitating its entry into cells. This could lead to more severe disease in some infants who receive the shot. Studies have shown that ADE can occur with RSV antibodies, particularly when they’re present at sub-neutralizing levels.

In laboratory experiments, RSV antibodies have been shown to enhance infection of certain cell types, including macrophages, which are important immune cells in the lungs. This raises concerns about whether nirsevimab could make RSV infections worse in some babies as the antibody levels wane over time.

Inadequate safety data and concerning trial results

Banoun’s study further points out that the clinical trials for nirsevimab have significant limitations that make it difficult to fully assess its safety. Many of the trials were conducted during periods of low RSV circulation, which means there weren’t many cases of severe RSV to compare between the treatment and placebo groups.

This limits the ability to draw firm conclusions about the shot’s effectiveness and, more importantly, its safety.

Some concerning trends emerged in the trials, but they were often dismissed due to small numbers. For example, in one study, babies who received nirsevimab and were still hospitalized for RSV stayed in the hospital longer than those who received a placebo.

This could potentially indicate more severe disease in some treated infants, but it wasn’t thoroughly investigated.

Even more worrying is the imbalance in deaths observed in some trials. The FDA noted that there were 12 deaths among 3,710 infants who received nirsevimab (0.32%) compared to four deaths among 1,797 infants in the control group (0.22%). While the overall numbers are small, this imbalance is concerning and deserves further scrutiny.

It’s also worth noting that a significant number of participants were excluded from the final analyses in these trials — anywhere from 2% to 8% of treated infants.

This type of exclusion can mask safety signals or artificially inflate efficacy estimates. When you’re considering a medical intervention for your baby, you want to be confident that all the data has been thoroughly and transparently analyzed.

Real-world risks and unknowns

As nirsevimab has been rolled out for widespread use in several countries, we’re starting to see some real-world data emerge. However, this early data raises more questions than it answers.

In France, where immunization coverage is estimated to be quite high, a concerning pattern has emerged. Of the 494 infants under 6 months old who were admitted to intensive care for bronchiolitis during the 2023-2024 season, 143 (29%) had received nirsevimab. Out of these admissions, 69% were due to RSV.

This doesn’t necessarily mean the shot is ineffective, as we don’t know what the numbers would have been without it. However, it does show that the shot is far from a guarantee of protection against severe RSV disease.

More worryingly, it suggests that some infants who receive the shot are still ending up with very serious respiratory infections.

There’s also the question of how nirsevimab might interact with your baby’s developing immune system. The shot provides artificially high levels of antibodies against one specific part of the RSV virus. We don’t yet know if this could interfere with your child’s natural development of immunity against RSV or other respiratory viruses.

Additionally, the pharmacovigilance data from Europe shows that the majority of adverse event reports for Beyfortus are related to respiratory issues, including bronchiolitis and RSV infections. While this doesn’t prove causation, it’s a signal that warrants careful monitoring and further investigation.

Given these risks and unknowns, you might be wondering if the potential benefits of the RSV shot outweigh the risks for your baby. While RSV can certainly be serious in some infants, the majority of babies recover without complications.

According to Nass:

“I previously revealed a published CDC paper from 2021 that showed only 25 babies up to one year of age die from RSV yearly in the entire US, averaged over 12 years. This is death certificate data, which CDC collects. It is considered THE GOLD STANDARD. 4 million babies are born yearly in the US. 20,000 die in their first year. RSV kills 0.125% of them. It is way down the list of top causes of death.”

Questionable cost-benefit for mass vaccination

While clinical trials showed some reduction in RSV-related hospitalizations, the overall impact on hospital burdens appears minimal. Importantly, all-cause hospitalization rates for infants and young children during the 2023-2024 season were not significantly reduced compared to previous years, Banoun’s study shows.

Economic analyses also suggest the current price makes mass vaccination of all infants difficult to justify from a cost-effectiveness standpoint. Some experts have proposed that an 80% to 88% price reduction would be necessary to make universal RSV shots for infants economically viable.

“Immunized children are protected from RSV for only 6 months,” Banoun writes, “nirsevimab-resistant strains are beginning to emerge. All studies conclude that the immunization program is cost-effective only if applied to at-risk infants.”

Since all-cause hospitalization rates haven’t decreased, the cost-benefit ratio looks even less favorable than initial projections.

Considering the potential for ADE, the limitations in safety data, and the early signals from real-world use, parents may want to carefully weigh whether this new intervention is truly necessary for their baby.

See more here The Defender

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