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The Centers for Disease Control and Prevention (CDC) last week issued a health advisory warning pediatricians and parents of a shortage of a new drug designed to protect newborns from severe cases of respiratory syncytial virus (RSV) — just as cases of RSV are expected to rise nationwide.
A week after the health advisory was issued, parents and pediatricians are struggling to find the new drug, nirsevimab, administered to infants and toddlers up to age 2 as a shot under the brand name Beyfortus.
In July, the U.S. Food and Drug Administration approved the Beyfortus shot “to prevent RSV in babies and toddlers,” in time for the drugmaker to roll it out for the October-to-March RSV season.
In August, the CDC’s Advisory Committee on Immunization Practices recommended the shot be given to all infants under 8 months old and to high-risk children 8-19 months old.
But “unprecedented demand for Beyfortus” overwhelmed the company’s supply, according to drugmaker Sanofi, which developed and manufactures nirsevimab in partnership with AstraZeneca.
As a result of the shortage, the CDC said in its health advisory that pediatricians should prioritize giving the shot to infants under 6 months old or those with high-risk health conditions.
Dr. Coleen Cunningham, chair of pediatrics at the University of California, Irvine, said the restrictions are logical given the shortage and the fact that older children are much less likely to suffer serious illness.
“The vast majority of the severe illness and hospitalization is in kids in the first six months of life,” Cunningham, who also is chief pediatrician at Children’s Hospital of Orange County, told The New York Times.
Others were disappointed that the drug, a monoclonal antibody therapy, was unavailable.
“I had hoped we learned lessons from covid, where we foresee these challenges [because] it seems like this was a preventable shortage where we should have anticipated the demand,” Roberts said.
RSV is a common respiratory virus that “usually causes mild, cold-like symptoms,” the CDC says. “Most people recover in a week or two, but RSV can be serious. Infants and older adults are more likely to develop severe RSV and need hospitalization.”
According to the CDC’s surveillance estimates of the disease, widely reported in the Times and elsewhere, RSV is the top cause of hospitalization for babies less than a year old in the U.S. and leads to 58,000-80,000 hospitalizations and 100-300 deaths annually among children under 5.
But Dr. Meryl Nass, internist and member of the Children’s Health Defense scientific advisory committee, disputed the CDC’s estimates of RSV infant deaths as overplayed.
“The CDC is trying to make everyone frightened” of RSV, she said.
In fact, she said, 97% of all babies have been infected with the common RSV virus by age 2, providing them partial immunity and protection against severe cases.
While in especially young infants, RSV can cause difficulty breathing, creating the need for hospitalization, IV fluids and oxygen, Nass said: “virtually every baby, even if they’re hospitalized, will get over this with no chronic problems.”
Nass also called into question the CDC’s estimates of how many children die annually from RSV.
She pointed to a 2001 study that measured the severe RSV burden on U.S. health by studying “U.S. death certificate data for all ages from 2005 through 2016” from the National Center for Health Statistics.
In the 12 years studied, a total of 1,001 death certificates in all age groups in the U.S. listed RSV as a cause of death — an average of fewer than 100 RSV deaths a year across all age groups.
In addition, Nass said, among the tens of millions of babies born in the U.S. during that 12-year period — an average of about 4 million babies born each year — infants under age 1 were at the highest risk of RSV deaths.
Yet the study found only 26 death certificates in that age group listing RSV across 12 years — and only 17 of those certificates blamed RSV as the underlying cause of death.
Doctors cite cost and potential risks of RSV shots
Some doctors blamed the shortage of Beyfortus primarily on its cost — $495 per dose, the most expensive shot administered to children.
Doctors “are holding out on ordering it because insurance companies haven’t committed yet to cover it,” said Dr. Steven Abelowitz, a pediatrician from Southern California, who said price was a major deterrent for his practice.
“We’re struggling to come to a decision,” he told The Washington Post. “It’s just an exorbitant amount of money.”
Though Befortus is not a vaccine, the federally funded Vaccines for Children Program pays $395 a dose for the shot and will make it available to lower-income families for more “equitable” distribution, the drugmaker said.
Given the shortage of the monoclonal antibody shot, the CDC advises expectant mothers to consider the RSV vaccine Abrysvo by Pfizer, which the CDC recommends for pregnant women to confer protection to newborns.
“The earliest available option is for pregnant women to get the [RSV] vaccine,” Dr. Michael G Knight, a clinical assistant professor of medicine at the George Washington University School of Medicine & Health Science, told ABC News.
Nass said the CDC recommendations on the shortage of the RSV antibody, combined with the agency’s recommendation on pregnant mothers choosing the RSV vaccine instead, is causing confusion in the marketplace.
But shortages and refusals of these dangerous products are nothing but good news, she said.
Monoclonal antibodies have never been given to babies and never injected in any group en masse, while the risks are unknown and outweigh any benefits, she said.
“I’m outraged by the attack on fertility and babies,” Nass said.
Dr. James Thorp, a Florida obstetrician and gynecologist whose groundbreaking study documented unprecedented harm in mothers and children from the mRNA COVID-19 vaccines, was also outraged that the reported monoclonal antibody shortage is leading to a greater push to inject pregnant women with the Pfizer RSV vaccine he called “an abomination.”
Thorp pointed to an analysis of the risk-reward of the Pfizer vaccine for pregnant women based on the drugmaker’s own studies, “Pfizer’s RSV Vaccine Math: Kill 4,000 Newborns to Save 300 from RSV.”
“The RSV vaccination in pregnancy is extremely dangerous and unforgivable,” Thorp said. “I think all the vaccines are overhyped.
“I’m not a vaccinologist or a pediatrician,” he said. “But it appears to me that with the skyrocketing chronic diseases in children and adults that have occurred coinciding with the aggressive vaccine rollouts indicate that they all should be subjected to randomized, double-blinded, placebo-controlled trials.”
“Why should all the new vaccines be held up as a sacred cow or golden calf? Why are the government and drug companies allowed to make false claims that cannot be made with even nutraceuticals?”