A vaccine to protect babies against RSV is almost here, but children in need may struggle to get it

After more than five decades of trials, the pharmaceutical industry is on the verge of delivering effective immunizations against respiratory syncytial virus, which has hospitalized about 90,000 American infants and young children since early October.

But only one of the vaccines is designed to be given to babies, and a glitch in Congressional language may make it difficult to let children in low-income families get it as easily as the well-insured.

Since 1994, routine immunization has been a childhood right under the Vaccines for Children program, through which the federal government purchases millions of vaccines and provides them free through pediatricians and clinics to uninsured children, underinsured or on Medicaid – more than half of all American children.

The 1993 law creating the program did not specifically include antibody injections, which were used only as a rare emergency treatment 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 rather an antibody. monoclonal that neutralizes RSV in the blood.

The Centers for Disease Control and Prevention’s Immunization Practices Advisory Committee is certain to recommend giving the antibody to infants, said Dr. Kelly Moore, president of 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.

Failure to do so “would lead thousands and thousands of infants to hospitalization and serious illness for semantic reasons despite the existence of an immunization that functions functionally like a seasonal vaccine,” Moore said.

Officials at Sanofi, which produces the nirsevimab injection with AstraZeneca, declined to state a price, but said the range would be similar to that of a pediatric vaccine. The CDC pays about $650 for the most expensive routine vaccine, the four shots for pneumococcal infection. In other words, FDA approval would make nirsevimab a blockbuster drug worth billions each year if given to a large portion of the approximately 3.7 million children born in the United States each year.

Pfizer and GSK manufacture traditional RSV vaccines and are awaiting 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 infants are in the works, but some experts are still nervous about them. A 1966 RSV vaccine trial failed spectacularly, killing two toddlers, and immunologists don’t fully agree on the cause, said retired National Institutes of Science scientist Dr Barney Graham. Health whose studies on the episode contributed to the success of the Covid and RSV vaccines.

After two years of Covid shutdowns and masking that slowed its transmission, RSV exploded across the United States this year, overwhelming pediatric intensive care units.

Sanofi and AstraZeneca hope to get nirsevimab approved by the FDA, recommended by the CDC and rolled out nationwide by fall to prevent future RSV outbreaks.

Their product is designed to be supplied before a baby’s first RSV winter season. In clinical trials, the antibodies provided up to five months of protection. Most children would not need a second dose because the virus is not life-threatening to healthy children over the age of one, said Jon Heinrichs, a senior member of the vaccines division of Sanofi.

If antibody treatment is not accepted for the Vaccines for Children program, it will limit access to the vaccine for uninsured people and those on Medicaid, the majority of whom represent racial or ethnic minorities, Moore said. Drugmakers would have to negotiate with each state’s Medicaid program to get it on their formularies.

Excluding the vaccine from Vaccines for Children “would only exacerbate existing health disparities,” said Dr. Sean O’Leary, professor of pediatrics at the University of Colorado and chair of the infectious disease committee of the American Academy of Pediatrics.

RSV affects babies of all social classes, but tends to hit poor and crowded households hardest, Graham said. “A family history of asthma or allergy makes it worse,” he said, and premature babies are also at higher risk.

While 2-3% of American infants are hospitalized each year for RSV, only a few hundred die from it. But up to 10,000 people age 65 and older perish each year from infection, and a little-discussed legal change will make RSV and other vaccines more accessible to this group.

A section of the 2022 Cut Inflation Act that went into effect Jan. 1 ends out-of-pocket payments for all vaccines by Medicare patients — including RSV vaccines, if allowed for this group.

Before, “if you hadn’t reached your deductible, it could be very expensive,” said Dr Leonard Friedland, vice president of scientific affairs and public health for GSK’s vaccines division, which also makes the vaccine. shingles and tetanus-diphtheria-pertussis combination. boosters covered by the new law. “This is an extremely important step forward.”

Of course, high levels of vaccine hesitancy are likely to blunt vaccine uptake regardless of who pays, said Jennifer Reich, a sociologist at the University of Colorado who studies attitudes in vaccination matters.

New types of vaccines, like Sanofi-AstraZeneca antibodies, often alarm parents, and Pfizer’s vaccine for pregnant women is also likely to push fear buttons, she said.

Public health officials “don’t seem very knowledgeable about how to get ahead” of claims that vaccines impair fertility or otherwise harm people, Reich said.

On the other hand, this winter’s RSV outbreak will convince many parents, said Heidi Larson, head of the Vaccine Confidence Project and professor of anthropology at the London School of Hygiene and Tropical Medicine.

“It’s a scary thing to have your child hospitalized with RSV,” she said.

While unfortunate, “the high number of children who have died or been admitted to intensive care over the past season with RSV – in some ways that’s helpful,” said Dr Laura Riley, president of obstetrics and gynecology at Weill Cornell Medicine in New York. .

Experts in her 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 is waiting to see if it gets approved,” she said. “Education must start soon, but it is difficult to deploy education before deploying fire.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with policy analysis and polling, KHN is one of the three main operating programs of KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization providing information on health issues to the nation.

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