By
(READ) FDA fast-tracked RSV shot linked to infant deaths
https://ift.tt/Dzr4lVP
The following is from Children’s Health Defense.
Nirsevimab, marketed by Sanofi and AstraZeneca as Beyfortus is a drug developed to protect infants from RSV (respiratory syncytial virus), a virus that can lead to serious respiratory infections. It was fast-tracked for approval by the US Food and Drug Administration (FDA) in July 2023.
The Centers for Disease Control and Prevention (CDC) recommends Beyfortus for infants younger than 8 months entering their first RSV season and for high-risk children aged 8-19 months. The shot is included in the 2024 Childhood Immunization Schedule.
The increased mortality risk and adverse effects of Beyfortus were highlighted by the Japanese journal Med Check, which reanalyzed clinical trial data. Med Check found that infants treated with Beyfortus experienced significantly higher death rates compared to those given a placebo, likely due to adverse effects such as blood clotting (thrombosis). The analysis concluded that “nirsevimab should not be used in any infants.”
These warnings were further confirmed by France’s National Agency for the Safety of Medicines and Health Products (ANSM), which tracked Beyfortus during the 2023-24 RSV season. While the data is based on French cases, it highlights potential serious risks for all infants receiving the shot.
Death cases from SIDS (Sudden Infant Death Syndrome):
- A newborn found lifeless two-and-a-half hours after a bottle feeding, three days after receiving Beyfortus.
- A newborn who received the Beyfortus shot on the second day of life and died 10 days later.
- An infant who required intensive care at birth but recovered and received its mandatory injections—including Beyfortus. Two-and-a-half months after the injection, the baby developed an RSV infection and died three days later.
Full list of other serious adverse events reported:
- 7 respiratory, heart, and lung disorders
- 4 gastrointestinal disorders
- 10 skin and subcutaneous tissue disorders
- 3 nervous system disorders, including 1 stroke and 2 cases of hypotonia
- 1 serious kidney disorder
- 9 general disorders, including tachycardia (irregular heartbeat), serious flu-like symptoms, and fever
- 11 cases of injuries, poisoning, and intervention complications
- 1 serious kidney infection
- 4 administration site abnormalities
- 148 cases of serious drug inefficacy, where infants developed RSV infections shortly after receiving the injection. Many of these infants were hospitalized.
Despite these findings, Beyfortus remains part of the US immunization recommendations, raising concerns about its safety profile.
For more information, you can read the Med Check analysis here.
Read the full article from Children’s Health Defense here.
The post (READ) FDA fast-tracked RSV shot linked to infant deaths appeared first on Sharyl Attkisson.
news
via Sharyl Attkisson https://ift.tt/nh26WNI
October 16, 2024 at 08:09AM
October 16, 2024 at 09:51AM
via Comments on: (READ) FDA fast-tracked RSV shot linked to infant deaths https://ift.tt/Dzr4lVP