New tools to fight RSV could be game changers for Arizona babies, pregnant people, seniors
New tools to prevent potentially deadly RSV infections could drastically reduce a regular seasonal influx of infants and other patients to Arizona hospitals this fall and winter.
RSV, or respiratory syncytial virus, is a serious problem in both the very old and very young. It is the leading cause of hospitalization among infants in the country, according to the the U.S. Centers for Disease Control and Prevention.
New tools to fight RSV recently approved by the U.S. Food and Drug Administration are targeted to three at-risk populations:
A monoclonal antibody RSV prevention shot for babies younger than 8 months.
An RSV vaccine for pregnant people.
An RSV vaccine for adults ages 60 and older based on shared decision-making with their provider.
Only the RSV vaccine for older adults is available now, but the others are expected soon.
The RSV vaccine for pregnant people still needs a recommendation from the CDC.
The monoclonal antibody shot, a single dose called nirsevimab − the trade name is Beyfortus − already has the CDC nod of approval. Health providers don't have it in stock right now, but it's expected to be available in the next few weeks. Beyfortus was developed by the British-Swedish drugmaker AstraZeneca in partnership with the French pharmaceutical company Sanofi.
"Obviously we want it to be available before we go into RSV season," said Dr. Wassim Ballan, who is the division chief of pediatric infectious diseases at Phoenix Children's Hospital. "We think that it's going to be a game-changer. We've been waiting for an RSV protection of some sort for years."
Each year, RSV routinely causes the deaths of 100 to 300 U.S. children under age 5 and is responsible for the hospitalization of tens of thousands more.
Public health officials are recommending eligible individuals get the influenza and updated COVID-19 shots to protect themselves this fall. For some people, the recommendation will be three shots − COVID-19, influenza and RSV.
"Eventually, all the vaccines will be easily accessible so that people can receive influenza vaccine, COVID-19 vaccine and (for the elderly) RSV vaccine at the same time," Dr. Karen Lewis, medical director for the Arizona Department of Health Services' Bureau of Immunization Services, wrote in an email. "Once nirsevimab is available, all infants younger than eight months should get a shot to protect them from RSV during RSV season."
Many insurers are expected to cover the RSV vaccines and nirsevimab.
Officials with Blue Cross Blue Shield of Arizona, which is one of the state's largest health insurance companies, say they will cover the new recommended RSV prevention tools − the vaccines for older adults and pregnant people and the monoclonal antibodies for babies. Some enrollees may have to pay a cost share depending on their individual plan, yet many will not have to pay anything since the RSV tools are preventive, a spokesperson wrote in an email.
Here are seven things that Arizonans need to know about the RSV shots for fall:
When is RSV season in the continental U.S.? Typically October through March
RSV usually spikes around the end of December or early January in Arizona, and it's often known as a winter disease. However, cases can begin rising in the fall. That's why health providers want to see those at risk get one of the RSV prevention shots as soon as possible.
In 2021 and 2022, the U.S., including Arizona, experienced an unusually early RSV season. In 2021, Arizona cases spiked in September.
The RSV vaccine is available to older adults now. But not all of them may need it
Each year, 6,000 to 10,000 older adults in the United States die because of RSV, Lewis said. Those who are most at risk have chronic heart or lung disease, weakened immune systems, serious underlying health conditions, or they are adults living in nursing homes, she said.
RSV vaccines are available for older adults at many Arizona pharmacies and in some clinics now. The CDC says adults ages 60 and older may receive a single dose of the RSV vaccine based on discussions about the risk factors between the patient and health care provider.
The CDC's shared decision-making language means the federal agency is not necessarily recommending the RSV vaccine for all U.S. adults 60 and older, said Emily Richards, a pharmacist and medication use specialist for Phoenix-based Banner Health.
There are two similar RSV vaccines available for older adults — Abrysvo developed by New York-based Pfizer and Arexvy from the British drugmaker GSK. The RSV vaccine may be given at the same time as other vaccines, Lewis said.
Richards said Medicare Part D will cover the cost of the RSV vaccine for patients 65 and older. But Medicare beneficiaries who haven't signed up for the drug benefit may need to pay out-of-pocket, KFF Health News reported Aug. 24.
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Nirsevimab or Beyfortus is administered to prevent RSV in babies
Nirsevimab is a monoclonal antibody, not a vaccine. While RSV vaccines teach the body to fight the virus, monoclonal antibodies are man-made proteins that mimic the antibodies that our bodies naturally produce and help fight infections, the CDC says.
"The promise is that it's going to be available in the next few weeks," Ballan said on Aug. 24. "All hospitals and practices are now discussing it."
The CDC endorsed nirsevimab for infants and toddlers on Aug. 3. The federal agency recommends one dose for all infants younger than 8 months who are going into their first RSV season. For a small group of children between the ages of 8 and 19 months who are at increased risk of severe RSV disease, such as children who are severely immunocompromised, the CDC recommends a dose for their second RSV season, too. But for each RSV season, it's just one dose.
"The patients who are approved to get it can be as young as a day or two old, so just before they leave the hospital after birth and up to eight months," Ballan said. "So all the babies that are going to be born now or were born within the last few months will be eligible to get that injection."
The CDC's Advisory Committee on Immunization Practices voted to include nirsevimab in the Vaccines for Children program, which provides recommended vaccines and immunizations at no cost to about half of the nation’s children.
Access to nirsevimab this season could be a problem
Though it's expected to be available in the fall, it's unclear how many babies will get the nirsivemab shots.
One challenge is that nirsevimab is very expensive, at about $495 per dose, Lewis of the state health department wrote. Another challenge is that it always takes some time for health care facilities to carry a new medication and for health insurance to cover it, she said.
"Pharmacies do not immunize young children, so nirsevimab will not be available at pharmacies," Lewis wrote. "Clinics and hospitals will first need to figure out how to be reimbursed for such an expensive medicine before they can afford to carry it."
Abrysvo is for pregnant people but still needs CDC approval
The FDA on Aug. 21 approved Abrysvo in pregnant individuals for use at 32 through 36 weeks gestational age of pregnancy, though the CDC could still change that recommendation.
The purpose of Abrysvo for pregnant people is to "just basically boost their immune system to produce antibodies against RSV," Ballan said, and those antibodies will be passed on to the baby and protect the baby during the first six months of life.
Ballan said ideally a CDC advisory committee will consider Abrysvo for pregnant people in the next few weeks. If the committee upholds the FDA's recommendation and the CDC approves the committee recommendation, then the vaccine will become available, he said.
A new COVID-19 vaccine is anticipated but not yet available
A new, updated COVID-19 vaccine is expected to be available this fall and will replace the previous COVID-19 vaccine, which is often referred to as the bivalent booster.
Until the new vaccine is available, the old bivalent vaccine can be obtained in pharmacies and clinics for people who have not yet received it, Lewis wrote.
Influenza shots are available now
Influenza vaccines are recommended for everyone ages 6 months and older and are widely available at pharmacies, medical offices and hospitals, state health officials say. Influenza seasons vary in severity, but the virus comes every winter and sickens about 8% of the U.S. population per year, Lewis wrote.
"People at the highest risk of complications from influenza include young children, pregnant women, the elderly, people with chronic medical problems, and people with weak immune systems," Lewis wrote. "However, even healthy people can become quite sick from influenza and pass the infection on to other people."
The CDC as of Aug. 29 had reported 172 pediatric deaths from influenza during the 2022-23 flu season. Arizona state health data as of Aug. 12 shows six pediatric flu deaths for the 2022-23 season.
Reach health care reporter Stephanie Innes at Stephanie.Innes@gannett.com or at 602-444-8369. Follow her on X formerly known as Twitter @stephanieinnes.
This article originally appeared on Arizona Republic: New tools to battle RSV: What to do this fall to fight the virus
