CDC Advisory Panel Approves New Injection For Infants This Fall

The Advisory Committee on Immunization Practices (ACIP), an advisory panel for the U.S. Centers for Disease Control and Prevention (CDC), voted unanimously on Thursday to recommend a respiratory syncytial virus, or RSV, injection for infants under eight months of age.

After CDC Director Dr. Mandy Cohen signed off on the recommendation, the monoclonal antibody will be added to the CDC’s childhood immunization schedule.

The drug, manufactured by AstraZeneca and Sanofi, is designed to be given to infants in a single shot at birth or just before the start of a baby’s first RSV season.

It can also be given in a larger dose in a second RSV season in children who are highly vulnerable.

“In a second unanimous vote, ACIP also recommended that certain infants ages 8 to 19 months get a second dose of nirsevimab to help them through their second RSV season, if they have underlying health issues that put them at higher risk for hospitalization,” CNN reports.

All infants under 8 months of age should get a new antibody shot to protect against severe respiratory syncytial virus, or RSV, according to a panel of independent experts that advises the CDC on its immunization recommendations. https://t.co/N0kZCAuPPz

— CNN (@CNN) August 3, 2023

Per CNN:

The shot is the first product available to protect all newborns against RSV, a lung-attacking virus that is the leading cause of hospitalization in children who are under a year old. Cases tends to peak over the fall and winter months. Younger babies are at highest risk from the infection, which can fill tiny lungs with mucus, making it difficult for infants to breathe.

“I’m very excited about this. I think this is going to be incredible,” said ACIP member Dr. Helen Talbot, a pediatrician at Vanderbilt University after the vote. “I think this is life-changing and I’m very excited. I just hope we can get through the hurdles,” to get it to patients, Talbot said.

“Nirsevimab is a long-acting antibody — a protein that can recognize and handcuff RSV so it can’t infect cells — not a vaccine,” CNN noted.

The drug will be marketed under the trade name “Beyfortus.”

Although the drug, nirsevimab, isn’t a ‘vaccine,’ it’s still a dangerous injection that can catastrophically harm infants and toddlers.

In the drug’s clinical trial, 12 infant deaths were recorded.

WLTR previously noted that the FDA committee, which approved nirsevimab in June, said the deaths were “unrelated” to the antibody.

12 Infants Die in Clinical Trial For RSV Injection Approved by FDA Panel

Stop all vaccines. NOW: https://t.co/L19vRYMlX9

— Christiane Northrup (@DrChrisNorthrup) June 20, 2023

CNBC noted:

Twelve infants who received nirsevimab in the trials died. None of these deaths were related to the antibody, according to the FDA’s review.

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.

“Most deaths were due to an underlying disease,” Baylor said. “None of the deaths appeared to be related to nirsevimab.”

“Twelve Infants Perish in Clinical Trial for RSV Shot – FDA Recommends Anyway. Four of the twelve infants’ deaths in the AstraZeneca trial were from cardiac arrest, and two died of SIDS (Sudden Infant Death Syndrome),” Children’s Health Defense wrote.

“The FDA claimed the deaths were ‘unrelated’ to AstraZeneca’s monoclonal antibody injection, but how often do you hear about four babies naturally dying of cardiac arrest in a clinical trial setting?”

“The pediatricians are going to push this. The doctors, as soon as the babies are born, they’re going to give these babies this RSV jab,” CHDTV’s Polly Tommey said.

WATCH:

Twelve Infants Perish in Clinical Trial for RSV Shot - FDA Recommends Anyway

Four of the twelve infants’ deaths in the AstraZeneca trial were from cardiac arrest, and two died of SIDS (Sudden Infant Death Syndrome).

The FDA claimed the deaths were “unrelated” to AstraZeneca’s… pic.twitter.com/VuPqXkYZbX

— Children’s Health Defense (@ChildrensHD) June 12, 2023

“AstraZeneca reported only 48% efficacy for the drug,” The Defender stated.

“It’s preposterous to give this drug prophylactically, especially without adequate safety testing,” said Children’s Health Defense Senior Director of Science and Research Brian Hooker.

The Defender reports:

Hooker also commented on the fact that 12 infant deaths were recorded during the clinical trial, which the FDA committee claimed were “unrelated” to the antibody:

“It appears that this vote was meant to bolster uptake and popularity of the RSV vaccines that are now approved for maternal use. The very low rate of effectiveness for such a therapy is troubling as the conservative estimate is below 50%, which is usually a hard metric for drug approval.

“Also, it seems odd that four infants in the trial would die of cardiac arrest — with no information given, it leaves one to wonder why these children would die in such a way. Also, there should be further investigation into the two SIDS [sudden infant death syndrome] deaths that occurred during the trial.”

Dr. Meryl Nass, an internist, biological warfare epidemiologist and member of CHD’s scientific advisory committee, told The Defender, “It is reckless in the extreme to inject very young babies with an inadequately tested monoclonal antibody drug to prevent a condition that for most of them will be no more than a cold.”

Cardiologist Dr. Peter McCullough told The Defender that while monoclonal antibodies are “generally safe” for children, he questioned the benefit of such a treatment for what he called a “mild” infection. He said:

“Monoclonal antibodies are generally safe in children and adults; however, I am concerned broad infant population uptake may disrupt normal thymus and immune system development that easily handle infections such as RSV, influenza, rhinovirus, adenovirus and SARS-CoV-2.

“RSV is a characteristically mild infantile infection easily resolved with conventional nebulizers. I believe nirsevimab would not be clinical-indicated for all infants and likely would be utilized in high-risk babies with congenital heart or lung disease, such as cystic fibrosis, or those with prior thoracotomies for heart surgery, where respiratory mechanics would be compromised.”

AstraZeneca and Sanofi funded the clinical trial for nirsevimab.

From The New England Journal of Medicine:

Medimmune/AstraZeneca was involved in the trial design; the collection, analysis, and interpretation of the data; and the writing of the manuscript. The trial was funded by MedImmune/AstraZeneca and Sanofi. Medical writing support was funded by AstraZeneca and Sanofi.

The CDC advisory panel's approval paves the way for the RSV injection to be available this fall.

Via CNBC:

AstraZeneca and Sanofi are prepared to roll the shot out before RSV season this fall and do not foresee any challenges meeting demand, a Sanofi spokesperson said.

Dr. Sarah Long, a panel member, described Beyfortus as a milestone.

“This is the very first antibody protection against a remarkably remaining burden of disease in children,” said Long, a professor of pediatrics at Drexel University.

“Parents should be very, very much relieved that they won’t have to be concerned about the likelihood that their child could be hospitalized with RSV disease,” she said.

If Beyfortus receives CDC backing, most insurance plans will be required to cover the shot at no cost to consumers due to requirements under the Affordable Care Act. The shot has a list price of $495.

Though Long described the shot as a breakthrough, she said the CDC panel is “extremely disappointed” by the price set by Sanofi and AstraZeneca.

It could potentially take months for some insurance plans to update their policies to comply with the requirement.