by Brenda Baletti, Ph.D., Childrens Health Defense:
Two new reports raise concerns about the dangers of Beyfortus, an immunization against RSV for infants that the Centers for Disease Control and Prevention added last year to the Childhood Immunization Schedule.
Infants treated for RSV with the monoclonal antibody nirsevimab have significantly higher mortality rates than those treated with a different monoclonal antibody or with a placebo, according to an analysis by the Japanese journal Med Check of three major randomized control trials.
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The report reanalyzed clinical trial data showing that nirsevimab — marketed by Sanofi and AstraZeneca as Beyfortus — reduced RSV-associated lower respiratory tract infection and hospitalizations in both high-risk and healthy infants.
However, babies treated with the drug had a higher mortality rate likely linked to adverse effects — including thrombosis (blood clotting) — from the drug itself, the study found.
“Due to the increased mortality, nirsevimab should not be used in any infants,” the study concluded. “Do not use nirsevimab for universal immunization.”
Shortly after its approval by the European Medicines Association in October 2022, and fast-track approval by the U.S. Food and Drug Administration in July 2023, the U.S., France, Spain and Luxembourg launched universal Beyfortus infant immunization campaigns for the 2023-24 RSV season.
Med Check published its appraisal of the clinical trials shortly after France’s National Agency for the Safety of Medicines and Health Products (ANSM) published its first pharmacovigilance data on the drug, compiled during the 2023-24 season.
The ANSM report tracked adverse events related to Beyfortus in France between Sept. 11, 2023, and April 30, 2024. Of 244,495 doses delivered, 198 adverse events were reported to the pharmacovigilance system, of which 153 were considered serious.
The report identified safety signals for stroke, respiratory conditions and hypotonic-hyporesponsive episodes — when an infant suddenly loses muscle strength and becomes “floppy.” Hypotonic-hyporesponsive episodes also are associated with the diphtheria-tetanus-pertussis, or Tdap, vaccine and other vaccines.
There were also three reports of sudden infant death syndrome (SIDS), although researchers said at least one of them was likely not linked to the drug.
The ANSM said each of the signals would be closely monitored in the future, but that a causal link between Beyfortus and those adverse events had not yet been established. The agency concluded the results confirm that the benefits of using the drug to treat bronchiolitis, an RSV infection, outweigh the risks.
The ANSM continues to recommend all newborn babies receive the Beyfortus shot this RSV season.
RSV is a common respiratory virus that usually causes mild cold-like symptoms. However, it can lead to hospitalization for bronchiolitis or pneumonia in about 1%-2% of infants, especially high-risk infants born preterm or who have chronic lung or congenital heart disease.
Approximately 100 infants reportedly die each year in the U.S. from the illness. By age 3 almost all babies have been infected with RSV, which confers partial immunity and makes subsequent episodes less severe.
The Centers for Disease Control and Prevention (CDC) recommends one dose of nirsevimab/Beyfortus for infants younger than 8 months entering their first RSV season if their mother didn’t receive the RSV maternal vaccine during pregnancy, or if the mother’s immunization status is unknown.
The CDC also recommends the shot for infants and children ages 8-19 months at higher risk of severe RSV disease. The agency lists nirsevimab on the 2024 Childhood Immunization Schedule.
After Beyfortus was approved, a Freedom of Information Act request by The Defender revealed that at least two infant deaths reported to the Vaccine Adverse Event Reporting System or VAERS were linked to the drug.
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