FDA Approves Shot Despite Serious Adverse Health Events

• The research paints a different picture regarding clesrovimab’s effects — The trials involved 2,409 babies who received the injection and 1,202 who were given a placebo. These were healthy infants, ranging from early and moderate preterm to full-term.

The results were sobering. Among the babies given clesrovimab, there was a 50% higher risk of death compared to those in the placebo group. That’s three deaths in the shot group versus one in the placebo.

• Serious neurological adverse reactions were reported — According to a report from the Children’s Health Defense (CHD), “These included febrile convulsions, seizures, facial paralysis and brain injury at about three times the rate in the vaccine group (25 of 2,409) as the placebo group (4 of 1,202).”⁵

• The risk of respiratory tract infections (RTIs) also soared — According to the data, infants who received the shot had a 350% higher risk of getting an upper RTI and a 63% higher risk of lower RTIs. This is particularly ironic, considering this shot is supposed to prevent exactly these types of infections.

• Overall, the serious adverse event rate is 11.71% — Dr. Peter Selley, a general practitioner from the U.K. who has closely followed this drug’s development, notes that these effects are “concerning.” He also warns against the standardized dosing of this drug and its implications on very young children.

• Merck proudly notes that Enflonsia has about the same efficacy rate as Beyfortus — “In clinical trials, the shot reduced RSV-related hospitalization by 84.3% compared to placebo, and the incidence of RSV that needed to be medically attended by 60.5% versus placebo, through age 5 months in the clinical trials,” the CHD reports.

• These two shots have certain differences — Both clesrovimab and nirsevimab are monoclonal antibody shots; however, they bind to different antigenic sites — this complicates any comparison between the two. Another, as mentioned above, is the dosage per shot.

• One-time, uniform-dose shots carry risks — Unlike Beyfortus, which is given in a two-dose series in amounts that vary depending on the infant’s weight, Enflonsia is administered as a one-time, fixed-dose injection.⁷ Selley cautions against this standardized dosing, saying:

“The implications of this are that with only one dose of clesrovimab, tiny preterm babies under 5 kilograms are going to be injected with a relatively much bigger dose of the monoclonal antibody, leading to massive levels of the drug in their circulation. In most other fields of medicine, the aim is to find the lowest dose of a drug that is effective, as most side effects are dose-related.”⁸

• Adverse reports could be underreported — The U.S. Centers for Disease Control and Prevention (CDC) doesn’t directly monitor injuries from medications that are not vaccines; Instead, they rely on the FDA’s MedWatch system.⁹ This discrepancy not only leads to confusion among health care providers and the public about where and how to report side effects, but could also lead to adverse events being underreported, making it more difficult to accurately assess the injection’s safety profile.

• The rush to implement widespread use of these injections raises questions about long-term safety and economic feasibility — When Beyfortus was first released, internist and biological warfare epidemiologist, Dr. Meryl Nass expressed her concerns about the unknowns of the drug. On her Substack, Nass points out that no monoclonal antibody product has ever been given on a mass scale to children before.¹⁰

• The safety profile of nirsevimab is questionable — 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 — yet the product label mentions only rashes and anaphylaxis as potential side effects of this drug.¹¹

• Deaths during clinical trials may have been underreported — Nass points out that 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.¹²

• Antibodies in these shots could be engineered in a way that makes them more ineffective — Monoclonal antibody shots target the RSV fusion protein, but, here’s the catch — they are engineered to last longer in your baby’s body, with a half-life of 80 to 120 days.¹⁴ This unnatural modification could increase the risk of ADE as antibody levels gradually decline over time.

This is because the antibodies, at low concentrations, 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.¹⁵

• RSV antibodies can weaken your immunity by making your immune cells more prone to infections — Laboratory experiments have demonstrated that these antibodies enhance infection of certain cell types, such as macrophages, which are important immune cells in the lungs. This raises concerns about whether monoclonal antibody shots could make RSV infections worse in some babies as the antibody levels wane over time.

• Clinical trials conducted on nirsevimab have limitations that do not clearly assess its safety — Banoun’s study points out that many of the trials done on nirsevimab were conducted during periods of low RSV circulation — this means there weren’t many cases of severe RSV to compare between the treatment and placebo groups.¹⁶ This raises doubts about the shot’s reported accuracy, especially its effectiveness and safety.

For more about the research findings about nirsevimab and monoclonal antibody shots, read “Is the RSV Shot Worth the Risk to Your Baby?”

• RSV symptoms are similar to a mild cold — These include runny nose, coughing, sneezing, wheezing, and fever. Most children recuperate from RSV without any issues.

• In fact, 97% of all babies become infected with RSV by the time they turn 2 years old — This gives them partial immunity, so that when they become reinfected, the symptoms are less severe.

• However, in some infants, RSV can be dangerous — Babies that are born prematurely or with weakened immune systems are at risk of bronchiolitis or pneumonia when they acquire RSV and may need to be hospitalized. In U.S. babies younger than 1, RSV is the leading cause of hospitalization.¹⁸

• The mortality rate is significantly lower than expected — According to a 2021 study from the CDC,¹⁹ only a small percentage of children — 25 or fewer babies per year — succumb to the virus.

• During RSV season, avoid crowds and indoor daycares if you can — If you have a newborn — especially if your baby is a preemie or has any underlying health issues — avoid crowded indoor settings. This includes daycare centers, waiting rooms, and busy stores. The fewer RSV exposures your baby gets during the early months, the more time their immune system has to mature naturally.

• Breastmilk is best — Breastfeeding gives your baby passive immunity without the risks of injections. Your breast milk contains antibodies that help fight off RSV and many other infections. Many of breastfeeding’s benefits actually stretch out until adulthood. For more information, read “The Power of Breastfeeding.”

• Prioritize your own health during pregnancy to boost natural protection — The state of your health during pregnancy plays a central role in shaping your baby’s early immunity. Make sure to optimize your nutrient status (focusing on getting key nutrients like folate), avoid exposure to toxins, and improve your gut health — these all directly affect your baby’s development. Get sufficient high-quality sleep and reduce your stress as well.

• Get regular safe sun exposure for both you and your baby — Sunlight helps your body create vitamin D, which is foundational for immune strength and respiratory health. Aim for short, gentle sun exposure daily — especially morning sun. If your baby is old enough, allow them short periods of direct sun on their skin.

For you, daily morning walks outside without sunglasses or sunscreen support both vitamin D and melatonin production, which regulate your baby’s sleep cycles and immune rhythm.

• Keep your home environment clean, warm, and hydrated — Dry indoor air increases the chance that RSV will infect your baby’s respiratory tract. Use a clean humidifier to keep indoor humidity between 40% to 60% during the colder months. Keep your baby’s nose clear with saline drops and a suction bulb if needed. Wipe down commonly touched surfaces often — but skip harsh chemical cleaners.

Stick to natural disinfectants like vinegar or hydrogen peroxide to reduce toxin exposure while keeping your environment safe.