Virtually all U.S. newborn babies are eligible to get protection from RSV — a top cause of hospitalization for babies and toddlers — after a new injection won approval from the U.S. Centers for Disease Control and Prevention.
CDC Director Mandy Cohen on Thursday night confirmed an expert panel’s recommendation of the new preventive drug nirsevimab for all babies up to 7 months old if they are born during or facing their first season of respiratory syncytial virus (RSV). The season normally runs from around October to March in the northern hemisphere.
Although nirsevimab is a preventive monoclonal antibody and not a vaccine, the panel, CDC’s Advisory Committee on Immunization Practices (ACIP), also recommended including it in the federally funded Vaccines for Children list. Cohen’s announcement said CDC is working to make that happen.
Experts, including the CDC scientist in charge of responding to U.S. lung infection threats, spoke of the decisions in momentous terms.
“I would be remiss if I didn’t say that today is a historic event,” said Dr. José Romero, director of the CDC’s National Center for Immunization and Respiratory Diseases, asking to interrupt as the meeting ended.
“I think that we will look back on this, in a short period of time, and see what a major impact this vote has had on the health and well-being of children in the United States,” he said. “I think that this will mark one of the major accomplishments of the ACIP.”
Nirsevimab is a monoclonal antibody drug, administered by injection, that acts as prevention, like a vaccine. It’s called “passive prevention” because it doesn’t rely on reactions from the person’s own immune system to create guards against the virus.
The drug is to be known commercially as Beyfortus. It was developed jointly by the drug makers Sanofi and AstraZeneca.
In addition to recommending nirsevimab for all babies up to 7 months old, the CDC recommended it be given in a larger dose to certain toddlers from 8 months to 19 months old who are at severe risk of RSV disease and are facing a second RSV season, including those who were born prematurely with lung problems.
The baby drug is one of a series of breakthroughs in the decades-long fight against RSV, which is short for respiratory syncytial virus.
The drug company Pfizer is developing a first-of-its-kind vaccine for pregnant women that would prompt the woman to develop antibodies against RSV that she would then passed to her newborn.
In May, a vaccine for adults, the first of its kind against RSV, was approved by the Food and Drug Administration for people over 60. The vaccine, called Arexvy, was made by the drug firm GSK, which said it plans to have it available for distribution this fall.
Among adults 65 and older, RSV leads to approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths each year, according to the CDC.
Severe RSV is the leading cause of hospitalization in infants, according to the American Lung Association, and it can be unpredictable. Each year among children younger than five, RSV causes about 58,000-80,000 hospitalizations, according to the CDC, and 130 to 300 deaths.
Beyfortus has been shown to reduce the risk of both hospitalizations and healthcare visits for RSV in infants by about 80 percent, the CDC said in its announcement.
Experts on the committee raised concerns about how people with little money, transportation problems, or in health care deserts will get nirsevimab if the baby doesn’t get it in the hospital.
The drug’s protection doesn’t last all year, but was shown in some trials to last for 150 days. So if a baby’s not born facing an RSV season — which in Georgia might start in October — and didn’t get the drug in the hospital, there may be coverage disparities when RSV season approaches if it’s not easy for the parent to get the baby to a doctor’s appointment.
Some of the committee members and public commenters were critical of the price tag the drugmakers set for a single injection: $495.
“This is a real milestone,” said Dr. Sarah Long, an ACIP member and professor of pediatrics at Drexel University College of Medicine. However, she said, “we are extraordinarily disappointed with the price setting of the manufacturer.”
A representative of the drug company Sanofi replied simply that the price was “cost effective.”
Much of those costs may ultimately be borne by taxpayers and people paying their insurance premiums. That’s because under the Affordable Care Act, vaccines recommended by the CDC must be covered by private insurance. And the committee vote Thursday aimed to include nirsevimab among the federally-funded vaccines distributed by states to low-income kids.
Dr. Hugo Scornik, a Georgia pediatrician, was elated by the committee’s votes. Up to now, he said, babies at high risk of RSV disease, such as early premature babies with underdeveloped lungs, get an antibody called Synagis, but it has to be given once a month, and it’s only for certain babies, not all.
Scornik said the expense is certainly worth it considering the expense of a baby hospitalized with RSV.
“It’s something to celebrate,” said Scornik. “On a human level, it’s just a great day that we have this technology.”
Credit: Courtesy of AstraZeneca and Sanofi
Credit: Courtesy of AstraZeneca and Sanofi
TODDLERS TO BE ELIGIBLE FOR RSV
CDC Director Mandy Cohen on Thursday night signed off on a CDC expert panel’s recommendation of the antibody nirsevimab for all babies through seven months old facing RSV. But among older babies, from 8 months to 19 months old, only some with special vulnerabilities to RSV will be eligible. Who are they?
- Those with chronic lung disease from being born premature who required medical support any time during the six months before the second RSV season.
- Those who are severely immunocompromised.
- Those with cystic fibrosis who have manifestations of severe lung disease or weight-for-length lower than in the 10th percentile.
- Those who are American Indian and Alaska Native.
