Medical experts criticized the Centers for Disease Control and Prevention’s Thursday decision to recommend a “new immunization” for newborns to protect against respiratory syncytial virus, or RSV, calling the move unnecessary and not worth the known risks.
Beyfortus, also known as nirsevimab, is produced by pharma giants Sanofi and AstraZeneca.
In a press release, the CDC referred to the drug as a “powerful tool” and a “new immunization.” According to the agency:
“ACIP [Advisory Committee on Immunization Practices] voted to include nirsevimab in the Vaccines for Children program, which provides recommended vaccines and immunizations at no cost to about half of the nation’s children.
“CDC is currently working to make nirsevimab available through the Vaccines for Children program. Healthcare providers will be a key partner in CDC’s outreach efforts. Additional clinical guidance and healthcare provider education material will be provided by CDC in the coming months.”
According to The Associated Press (AP), the drug will be offered as a “one-time shot for infants born just before or during the RSV season and for those less than 8 months old before the season starts,” and for some high-risk 8-19-month-old infants.
Infants in the high-risk group include “immunocompromised children and those with chronic lung disease — as well as Native American and Alaska Native children, who have RSV hospitalization rates between four and 10 times that of the general population,” STAT News reported.
CDC’s ACIP approved the recommendations in a unanimous 10-0 vote. Although not bound by ACIP’s vote, CDC Director Mandy Cohen signed off on the recommendations later on Thursday, according to CNBC.
Beyfortus will be “broadly available for all infants regardless of whether they have a health condition,” CNBC reported, adding that it will be “administered as a single dose.”
Some medical experts criticized the recommendation, pointing to infant deaths that occurred during the clinical trial for Beyfortus and questioning the need for their widespread administration to this age group.
Cardiologist Dr. Peter McCullough told The Defender:
“While monoclonal antibodies are reasonably safe and effective, they are not clinically indicated nor medically necessary in all newborns.
“This new preventive strategy should be considered in rare cases with baseline lung disease such as severe asthma or cystic fibrosis. Injecting all newborns should be off the table and rejected by parents who want to avoid unnecessary drugs and potential harms.”
Brian Hooker, Ph.D., P.E., senior director of science and research for Children’s Health Defense (CHD), cited the significant number of infant deaths during Beyfortus’ clinical trial in his remarks:
“This is really too bad and seems to be a part of the Department of Health and Human Services’ scare tactics recently regarding RSV, which is generally a mild infection that finds its origin during the development of the polio vaccine.
“The efficacy of the antibodies from clinical trials is woefully low and the circulating half-life of such a therapeutic may be as low as two weeks.
“I’m also worried about allergic reactions in newborns, especially given the high dose of antibodies and especially given that 12 infants died in the experimental arm of the study.”
Some medical experts criticized the recommendation, pointing to infant deaths that occurred during the clinical trial for Beyfortus and questioning the need for their widespread administration to this age group.
Cardiologist Dr. Peter McCullough told The Defender:
“While monoclonal antibodies are reasonably safe and effective, they are not clinically indicated nor medically necessary in all newborns.
“This new preventive strategy should be considered in rare cases with baseline lung disease such as severe asthma or cystic fibrosis. Injecting all newborns should be off the table and rejected by parents who want to avoid unnecessary drugs and potential harms.”
Brian Hooker, Ph.D., P.E., senior director of science and research for Children’s Health Defense (CHD), cited the significant number of infant deaths during Beyfortus’ clinical trial in his remarks:
“This is really too bad and seems to be a part of the Department of Health and Human Services’ scare tactics recently regarding RSV, which is generally a mild infection that finds its origin during the development of the polio vaccine.
“The efficacy of the antibodies from clinical trials is woefully low and the circulating half-life of such a therapeutic may be as low as two weeks.
“I’m also worried about allergic reactions in newborns, especially given the high dose of antibodies and especially given that 12 infants died in the experimental arm of the clinical trial.”
Dr. Meryl Nass, an internist, biological warfare epidemiologist and member of the CHD scientific advisory committee, cited a CDC study indicating RSV’s low risk for babies.
She also cited the lack of demonstrated long-term efficacy for such monoclonal antibodies.
Nass also noted that there are risks associated with the administration of monoclonal antibodies more broadly, citing the Cleveland Clinic, which states that “Infusion reactions are common, and occur during or shortly after monoclonal antibody treatment.”
There are also “more serious but less common risks linked to unwanted immune system reactions, such as acute anaphylaxis, cytokine release syndrome (CRS) and serum sickness.”
[…]
ACIP ignores ‘unrelated’ infant deaths during Beyfortus clinical trial
Several infant deaths — 12 in all — were reported during the clinical trial, which the U.S. Food and Drug Administration (FDA) claimed during a June review were “unrelated” to the antibody. On Thursday, Jones repeated this claim during the ACIP meeting, stating that “no RSV-associated deaths were recorded.”
CNBC reported in June that of the 12 infants, “Four died from cardiac disease, two died from gastroenteritis, two died from unknown causes but were likely cases [of] sudden infant death syndrome, one died from a tumor, one died from COVID, one died from a skull fracture, and one died of pneumonia.”
[…]
Perhaps partially acknowledging such concerns, STAT News reported that “experts cautioned that rolling the drug out across the country would be difficult. The U.S. has never before tried to give this type of medicine to nearly every infant.”
[…]
Via https://childrenshealthdefense.org/defender/cdc-beyfortus-nirsevimab-rsv-shots-newborns/
Deeply, deeply shocking. Words fail me.