08/04/23| By Michael Nevradakis, Ph.D.| The Defender – CHD

The Centers for Disease Control and Prevention (CDC) on Thursday recommended the first-ever monoclonal antibody marketed as a defense for all newborns against respiratory syncytial virus, or RSV.

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 clinical trial.”

Is widespread administration of an RSV monoclonal antibody to infants needed?

According to the AP, “In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year and several hundred die,” while according to CNBC, “RSV is the leading cause of hospitalization among infants in the U.S.”

CNBC previously reported that the U.S. “suffered an unusually severe RSV season” last winter. The New York Times reported on a “tripledemic” involving RSV, flu and COVID-19, “that swamped children’s hospitals and some I.C.U. wards.”

According to the CDC, nearly all children are infected with RSV before the age of 2.

However, according to Nass, the risk of death from RSV is lower than the risk of injury or death by vaccines and other treatments being pushed for the illness.

In May, Nass wrote that the CDC published a paper on RSV deaths in infants between 2009 and 2021, which found “were only a total of 300 deaths in children less than one year over the 12 years, or 25 on average per year.”

Nass added at the time that the number of injuries that may be caused by vaccines or other treatments during pregnancy “is almost certainly going to outweigh the loss of 25 babies a year from RSV.”

Citing CDC figures, Nass wrote on her Substack yesterday that “4 million babies are born yearly in the U.S. 20,000 die in their first year. RSV kills 0.125% of them. It is way down the list of top causes of death.” She added:

“RSV almost never causes chronic problems, except perhaps asthma. Or maybe children with an asthma tendency are also more susceptible to severe RSV.

“RSV does hospitalize a lot of U.S. infants. It frightens parents and causes a lot of work for doctors. And so, this group of pediatricians on CDC’s advisory committee went gaga over this new product, which is supposed to be 70-80% effective at preventing severe RSV disease.”

More RSV drugs in the pipeline

According to the AP, Beyfortus “is expected to be ready in the fall before the RSV season, typically November through March.” Its expected cost is $495 per dose, which will be “covered by insurance,” although “[ACIP] Panelists acknowledged that it will be a challenge at first to give the shot and for providers to be reimbursed by insurers.”

CNBC reported that “It could potentially take months for some insurance plans to update their policies to comply with the requirement.”

For high-risk children in the 8-to-19-month group, “the drug will cost twice as much,” STAT News reported, because they will receive a second injection.

According to Endpoints News, Beyfortus has already received regulatory approval in the European Union, United Kingdom and Canada, but “it has not yet launched in any of those markets.”

The approval of Beyfortus comes as a range of RSV vaccines have recently been approved or are in the pipeline for approval.

In May, the FDA approved Pfizer’s Abrysvo for administration to pregnant women, despite concerns raised by some medical experts about premature births identified during clinical trials. FDA approval is expected later this month, according to the AP.

And also in May, the FDA approved Arexvy, an RSV vaccine developed by GlaxoSmithKline Biologicals (GSK), and Pfizer’s Abrysvo, for people ages 60 and older. In June, the ACIP recommended the two vaccines, and later that month, outgoing CDC Director Rochelle Walensky approved the recommendation.

Abrysvo has been linked to Guillain-Barré syndrome, a rare disorder in which the body’s immune system attacks its own nerves. Symptoms can range from brief weakness to paralysis.

Another monoclonal antibody for the treatment of RSV, palivizumab, is available on the market, but according to CNBC, it “is primarily used for pre-term babies and those with congenital heart and lung conditions” and “is also more difficult to administer because infants have to receive a shot monthly during RSV season.”

Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”