After more than five decades of trying, the pharmaceutical industry is on the way. To an effective shot vaccine against the respiratory syncytial virus. Which has hospitalized an estimated 90,000. US infants and young children since early October.
But only one of the shots is designed to be given to children, and a flaw. In congressional language could make it harder to allow children from low-income families. To get it as easily as the well-insured.
Since 1994, routine immunization has been a childhood entitlement under. The Immunization Program for Children, through which. The federal government purchases 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 Americans. children
The 1993 law creating the program did not specifically include the antibody shot. Which was used only as a rare emergency therapy when the bill was written.
But the first such drug to be available for children. Is not a vaccine but a monoclonal antibody that neutralizes RSV in the bloodstream.
The Centers for Disease Control and Prevention’s Advisory Committee. On Immunization Practices is certain. To recommend giving children antibodies. Said Dr. Kelly Moore, president of the advocacy group Immunize.org. Agency spokeswoman Kristen Nordlund told KHNK. That the CDC is currently evaluating whether nisvemumab will. Be eligible for the Vaccine for Children program.
Failure to do so “will send shot thousands of children to the hospital. And to serious illness for semantic reasons despite having. An immunization that works as effectively as a seasonal vaccine,” Moore said.
Officials at Sanofi, which is developing the nircevimab injection with AstraZeneca. Declined to give a price but said the range would be similar to the pediatric vaccine course. The CDC pays about $650 for the most expensive routine vaccine. Four shots against pneumococcal infections.
In other words, FDA approval would make nirsevimab a blockbuster drug. Or more babies born in the United States each year.
Pfizer and GSK are developing traditional vaccines against RSV and expect FDA approval later this year. Pfizer’s shot will primarily be given to pregnant women – to protect their babies from. The disease – while GSK’s will be given to the elderly.
Vaccines designed for children are in the pipeline, but some experts are still nervous about them. A 1966 RSV vaccine trial failed spectacularly, killing two children. And immunologists don’t fully agree on why, said Dr. Bernie Graham. Aretired National Institutes of Health scientist whose episodic studies contributed. To the successful Covid and RSV vaccines.
After two years of Covid lockdowns and masking to slow transmission, RSV exploded across. The United States this year, flooding pediatric intensive care units.
. In clinical trials, the antibodies provide protection for up to five months. John Henriques, a senior member of Sanofi’s vaccine division. Said most children will not need a second dose because the virus. Is not a serious threat to healthy children over one year of age.
If the Antibody Treatment for Children’s Vaccines program is not adopted. It will limit access to the shot for the uninsured and those on Medicaid, many of whom represent racial. Or ethnic minorities, Moore said. Drug manufacturers must negotiate with each state’s Medicaid program to get it on their formularies.
Dr. Sean O’Leary, professor of pediatrics at the University of Colorado and chairman. Of the American Academy of Pediatrics’ Infectious Diseases Committe. Said eliminating vaccine shots for children “will only worsen existing health disparities.”
RSV affects children of all social classes but hits poor, overcrowded families the most, Graham said. “A family history of asthma or allergies makes it worse,” he says, and premature babies are also at higher risk.
But the infection kills 10,000 people age 65 and older each year. And a little-discussed legislative change would make RSV and other vaccines more available to this group.
A section of the 2022 Inflation Reduction Act that went into effect Jan. 1 ends shot Medicare patients’ out-of-pocket payments. For all vaccines — including the RSV vaccine, if they’re licensed for this group.
Before, “If you didn’t meet your deductible, it could be very expensive,” says Dr. Leonard F.