After more than five decades of attempts, the pharmaceutical industry is on the brink of providing effective immunizations against respiratory syncytial virus, which has put an estimated 90,000 American babies and young children in the hospital since the beginning of October.
But only one of the vaccines is designed for babies, and a flaw in congressional language may make it difficult for children in low-income families to receive it as easily as those with good insurance.
Since 1994, routine vaccination has been a right of childhood under the Vaccines for Children program, through which the federal government buys millions of vaccines and provides them free through pediatricians and clinics to children who are uninsured, underinsured, or on Medicaid—more than half of all American children.
He 1993 law The program’s creation did not specifically include antibody injections, which were used only as a rare emergency therapy at the time the bill was written.
But the first such drug likely to be available for babies, called nirsevimab (it was approved in Europe in December and FDA approval is expected this summer), is not a vaccine but a monoclonal antibody that neutralizes RSV in the bloodstream.
The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention will surely recommend giving the antibody to infants, said Dr. Kelly Moore, president of the advocacy group Immunize.org. The CDC is currently evaluating whether nirsevimab would be eligible for the Vaccines for Children program, agency spokeswoman Kristen Nordlund told KHN.
Otherwise, “it would consign thousands and thousands of babies to hospitalization and severe illness for semantic reasons despite the existence of an immunization that works functionally as a seasonal vaccine,” Moore said.
Officials at Sanofi, which is making the nirsevimab injection along with AstraZeneca, declined to specify a price, but said the range would be similar to that of a pediatric vaccination course. The CDC pays about $650 for the most expensive routine vaccine, the four shots against pneumococcal infection. In other words, FDA approval would make nirsevimab a blockbuster drug worth billions a year if given to a large portion of the approximately 3.7 million children born in the US each year. anus.
Pfizer and GSK are making traditional RSV vaccines and are expecting FDA approval later this year. Pfizer’s vaccine would initially be given to pregnant women, to protect their babies from the disease, while GSK’s would be given to the elderly.
Vaccines designed for babies are in the works, but some experts are still nervous about them. A 1966 RSV vaccine trial failed spectacularlykilling two young children, and immunologists don’t fully agree on the cause, said Dr. Barney Graham, a retired National Institutes of Health scientist whose studies of the episode contributed to the success of the COVID-19 and RSV vaccines.
After two years of covid-19 lockdowns and masking reducing its transmission, RSV exploded in the United States this year, flooding pediatric intensive care units.
Sanofi and AstraZeneca hope to have nirsevimab approved by the FDA, recommended by the CDC, and distributed nationwide by the fall to prevent future RSV epidemics.
Their product is designed to be provided prior to a baby’s first winter RSV season. In clinical trials, antibodies provided up to five months of protection Most children would not need a second dose because the virus is not a fatal threat to healthy children older than one year, said Jon Heinrichs, a senior fellow at Sanofi’s vaccines division.
If the antibody treatment is not accepted for the Vaccines for Children program, that will limit access to the vaccine for the uninsured and those on Medicaid, most of whom represent racial or ethnic minorities, Moore said. Drug manufacturers would have to negotiate with each state’s Medicaid program to include it on their formularies.
Excluding the shot from Vaccines for Children “would only worsen existing health disparities,” said Dr. Sean O’Leary, a professor of pediatrics at the University of Colorado and chair of the American Academy of Pediatrics’ committee on infectious diseases.
RSV affects babies from all walks of life, but it tends to affect poor and crowded households the most, Graham said. “A family history of asthma or allergies makes it worse,” she said, and premature babies are also at higher risk.
While 2-3% of US babies are hospitalized with RSV each year, only a few hundred die. But as many as 10,000 people Those 65 and older die from an infection each year, and a little-discussed legal change will make RSV and other vaccines more widely available to this group.
A section of the Inflation Reduction Act of 2022 that went into effect on January 1 eliminate out-of-pocket payments for all vaccines for Medicare patients, including RSV vaccines, if licensed for this group.
Before, “if you hadn’t met your deductible, it could be very expensive,” said Dr. Leonard Friedland, vice president of scientific affairs and public health at GSK’s vaccines division, which also makes shingles and tetanus-diphtheria and combination whooping cough. drivers contemplated in the new law. “This is a tremendously important advance.”
Of course, high levels of vaccine reluctance are likely to undermine acceptance of injections, regardless of who pays, said Jennifer Reich, a sociologist at the University of Colorado who studies attitudes toward vaccination.
New types of vaccines, such as Sanofi-AstraZeneca’s antibodies, often alarm parents, and Pfizer’s vaccine for pregnant women is also likely to create fear, he said.
Public health officials “don’t seem very smart about how to preempt” claims that vaccines undermine fertility or harm people, Reich said.
On the other hand, this winter’s RSV epidemic will be persuasive for many parents, said Heidi Larson, leader of the Vaccine Confidence Project and professor of anthropology at the London School of Hygiene and Tropical Medicine.
“It’s scary to have your child hospitalized with RSV,” she said.
While unfortunate, “the large number of children who have died or been admitted to the ICU in the last season with RSV is helpful in some ways,” said Dr. Laura Riley, chair of obstetrics and gynecology at Weill Cornell Medicine in New York City. .
Specialists in their field haven’t really started talking about how to communicate with women about the vaccine, said Riley, who chairs the immunization group at the American College of Obstetricians and Gynecologists.
“Everyone has been waiting to see if it passes,” he said. “Education needs to start soon, but it is difficult to implement education before launching the injection.”
KHN (Kaiser Health News) is a national newsroom that produces detailed journalism on health issues. Along with Policy Analysis and Polling, KHN is one of the top three operating programs in KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization that provides information on health issues to the nation.
