Topline:
Tens of thousands of doses of a new RSV shot are being shipped to pediatricians nationwide. The move comes after months of shortages.
What is going on? The CDC announced 77,000 doses of the shot will be dispersed immediately, as RSV cases increase. The shot provides protection for infants for about five months, long enough to get vulnerable babies through their first respiratory virus season.
Why does it matter? RSV is the leading reason babies under a year old end up in the hospital. An estimated 100-300 infants die from it in the U.S. every year.
Is it enough? Orange County pediatrician Eric Ball doesn’t think so. “There’s about 10,000 babies born each day, so even releasing about 77,000 new doses is only about enough for a week’s worth of babies,” he said.
What’s next? Supply isn’t the only issue. Many commercial insurance companies are not covering the shot, forcing parents to make a heart-wrenching choice.
Tens of thousands of doses of a new RSV shot will be shipped to pediatricians and hospitals throughout the country, as a months-long nationwide shortage collides with an increasing number of cases.
The long-acting monoclonal antibody is administered as an injection to infants to protect them from severe illness caused by the respiratory syncytial virus — or RSV infections, which are the leading cause of hospitalization among babies.
The additional 77,000 doses “will be distributed immediately” through the Vaccines for Children Program and commercial channels, according to the Centers for Disease Control and Prevention.
“That’s a good first step, but there are about 10,000 babies born in the U.S. each day, so this will cover us for a week,” said Orange County pediatrician Eric Ball.
“I have about 30 doses,” he added. “Right now we have to ration and we're turning people away because we just can't get the shot.”
The shot is a monoclonal antibody treatment, not a traditional vaccine. The lab-grown proteins supplement a baby’s underdeveloped immune system and give them immunity for about five months, long enough for them to get through their first respiratory virus season when they're at highest risk for complications.
Nirsevimab is approved for all infants up to 8 months old, and for some older babies and toddlers considered at higher risk due to RSV. The American Academy of Pediatrics recommends that every baby whose mother did not get the RSV vaccine while pregnant receive nirsevimab in the first week of life.
In clinical trials, the shot reduced RSV hospitalizations and health care visits in infants by almost 80%.
Doctors hoped the immunization would be a game changer in pediatrics. Ball said it’s devastating for babies to contract RSV and can affect survivors' lungs for years to come.
“They get fluid in their lungs, and the hardest thing about RSV is there's no effective treatment,” Ball said. “You just have to kind of support them and wait it out. So a lot of these babies are in the hospital for a week or more on oxygen until their body can fight it off and they get better on their own, and some don’t make it.”
The new shot for babies and toddlers became available in September. By mid-October, demand for nirsevimab had already outstripped supply, according to the pharmaceutical company Sanofi.
In response, the CDC issued guidance in October advising pediatricians to allocate the limited supply of doses by focusing on the infants at highest risk of RSV complications: babies under 6 months old and those with underlying medical conditions.
That leaves pediatricians to decide who gets the shot — and who doesn’t.
What is RSV?
Respiratory Syntactical Virus is the leading reason babies under a year old end up in the hospital, and an estimated 100-300 infants die from it in the U.S. every year.
The common respiratory virus can cause colds in adults, but can cause difficulty breathing in babies become deadly for young children and older adults.
It can spread when someone with the virus sneezes or coughs, through close contact with someone who is sick, or by touching infected surfaces and then touching your face without first washing your hands.
“We're seeing a lot of RSV right now. I had a [patient] admitted to the hospital just last week,” Ball said. “I fear for what's going to happen this winter. It's hard for us to have these babies who get sick or admitted to the hospital with something that theoretically could have been prevented.”
Different vaccine supplies for different insurance
There are two parallel vaccine systems in the United States. Children with commercial health insurance, such as through their parent’s employer, receive vaccines through the commercial market. Children with government insurance, such as Medi-Cal, get shots through the federally funded Vaccines for Children program, which provides vaccines to half of all children in the U.S.
Ball said his practice has never received RSV shots through the Vaccines for Children program, meaning none of his patients on Medi-Cal have been immunized.
“And they are the most vulnerable,” Ball said. “It’s just horrible.”
The shot comes with a hefty price tag of $495 per dose, making it the most expensive standard childhood shot.
Due to a quirk in the Affordable Care Act, commercial insurance plans can wait up to a year before they are required to cover it.
That leaves parents whose insurance won’t cover it with a gut-wrenching decision: Do they pay hundreds of dollars for an expensive immunization that will protect their child during the RSV season or take the risk their child may get sick and end up in the hospital?
“It's a terrible decision and dilemma that we're putting our families through,” Ball said. "If an insurance company is not going to pay for it, we're putting the burden of that cost onto a family with a newborn baby. And it leads to inequities in our health care system, where only rich people can protect their babies."
Pediatricians say the high cost of the shot slows down the dissemination of the medication, along with the many bureaucratic obstacles in Medicaid's system for vaccine distribution to children.
RSV shot for pregnant people
Another shot that also protects babies is available for a specific window during pregnancy, and it’s readily available.
Pregnant people between 32 and 36 weeks can get immunized and the protection is transferred to their baby in utero, negating the need for the child to get the shot as a newborn. It has an added bonus of protecting the pregnant person from RSV infection.
“If you're pregnant and you're in that range, get that now so that you don't have to go through this rigmarole of having to get insurance authorization or shopping around to find a place that has the RSV immunization,” Ball said.
“It's much easier for the pregnant people to get vaccinated than to do the babies.” he said.
