By Brenda Goodman and John Bonifield, CNN
(CNN) — All infants under 8 months of age should get a new antibody shot to protect against severe respiratory syncytial virus, or RSV, according a recommendation from the US Centers for Disease Control and Prevention.
A panel of independent experts that advises the agency – the Advisory Committee on Immunization Practices, known as ACIP – voted unanimously on Thursday to recommend the injection, which will be added to the CDC’s childhood immunization schedule now that CDC director Dr. Mandy Cohen has signed off on the recommendation.
In a second unanimous vote, ACIP also recommended that certain infants ages 8 to 19 months get a second dose of nirsevimab to help them through their second RSV season, if they have underlying health issues that put them at higher risk for hospitalization.
The shot is the first product available to protect all newborns against RSV, a lung-attacking virus that is the leading cause of hospitalization in children who are under a year old. Cases tends to peak over the fall and winter months. Younger babies are at highest risk from the infection, which can fill tiny lungs with mucus, making it difficult for infants to breathe.
“I’m very excited about this. I think this is going to be incredible,” said ACIP member Dr. Helen Talbot, a pediatrician at Vanderbilt University after the vote. “I think this is life-changing and I’m very excited. I just hope we can get through the hurdles,” to get it to patients, Talbot said.
RSV hits certain racial and ethnic groups harder than others. American Indian and Alaska Native children have hospitalization rates for RSV that are 4 to 10 times higher than the general population, so the CDC said they should be eligible to get a second shot, too.
Nirsevimab is a long-acting antibody — a protein that can recognize and handcuff RSV so it can’t infect cells — not a vaccine. It will be marketed under the trade name Beyfortus.
Committee members also voted to add the shot to the federally funded Vaccines for Children Program, which provides immunizations free-of-charge to children who might not get them otherwise.
“This new RSV immunization provides parents with a powerful tool to protect their children against the threat of RSV,” Cohen said in a statement. “RSV is the leading cause of hospitalizations for infants and older babies at higher risk and today we have taken an important step to make this life saving product available.”
The shot will be the first form of passive immunization added to the childhood immunization schedule.
In contrast to vaccines, which prompt the body to make antibodies against pathogens, passive immunizations don’t require the body to make anything. These therapies send protective antibodies into the body ready to go to work.
Sanofi and AstraZeneca, the two companies marketing nirsevimab, say it should be available to patients in a few months, in time for this year’s RSV season.
“Today, we have turned the corner on the threat of RSV to our youngest, most vulnerable population,” said Thomas Triomphe, executive vice president for vaccines at Sanofi. “The ACIP’s unanimous recommendations for routine use of Beyfortus and inclusion in the Vaccines for Children program are critical steps toward providing millions of parents in the U.S. with the ability to protect their babies through their first RSV season, when they are most susceptible to severe RSV disease.”
The new recommendations should greatly expand access to the therapy, which is a long-acting antibody. Antibody therapies like this one can cost hundreds of dollars for a single dose, so even families with insurance coverage might wind up with sizable co-pays for this protection.
But the thumbs up from the ACIP means the new shot will be available to all infants with no out-of-pocket cost to families. The federal Affordable Care Act mandates that insurance plans cover ACIP-recommended immunizations with no cost sharing to patients.
Insurance coverage may take time to kick in, however. Under the law, companies have a year to implement coverage for new products and that coverage would then take effect in the next plan year, so it may be as long as 18 months until some plans begin covering.
Drug manufacturers have not announced Beyfortus’s price, but during the meeting, Sanofi said that if the shots is recommended for all infants, it will cost $495 per dose for private payors and $395 for the government’s Vaccines for Children program. CDC experts modeled a list price of $495 per dose and determined that it is cost effective for the government to cover it.
‘A spectacular advancement’
In clinical trials, the injection cut the risk that a baby would need to be hospitalized because of RSV by about 75%. It was 90% effective preventing the need for intensive care for babies with RSV.
In real terms, the therapy is estimated to prevent one doctor’s visit for every 17 babies treated, one emergency room visit for every 46 infants treated and one hospital admission for every 128 babies treated, the CDC said.
“I do believe that in terms of the innovation of this, this is a really important step forward,” said ACIP chair Dr. Grace Lee, a pediatrician at the Stanford University School of Medicine.
Nirsevimab is effective for about five to six months, so it needs to be given as close to RSV season as possible, which is typically between October and March in the United States, but can vary in places with warmer or colder climates.
“As we head into respiratory virus season this fall, it’s important to use these new tools available to help prevent severe RSV illness,” Cohen said. “I encourage parents of infants to talk to their pediatricians about this new immunization and the importance of preventing severe RSV.”
The CDC says infants born during or shortly before RSV season should get a shot of nirsevimab during their first week of life. Those who are younger than 8 months of age who haven’t had a shot should get one shortly before RSV season, CDC said.
Babies who are between 8 and 19 months of age and have underlying risks that make them more vulnerable to hospitalization — this includes preemies with underdeveloped lungs, children with cystic fibrosis, and those with severely compromised immune systems — can get a second dose to get them through their second season, the CDC said.
“This is a spectacular advancement. It’s going to help families and offices and keep kids out of the hospital. And two years from now, it’ll be covered by insurances and all the implementation will be in place. So there will be growing pains but I don’t want to lose sight of how important this advancement is,” said ACIP member Dr. Jamie Loehr, a family physician in New York.
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