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Spotlight on Vaccines: 2023’s RSV Immunization Approvals

By Jayne Hornung

Respiratory syncytial virus (RSV) can impact anyone, but infants and older adults are most at risk of illness. With multiple new immunizing agents gaining FDA approval in 2023—and more in the pipeline—manufacturers and payers have a role to play in educating patients and providers about the importance of immunizations to combat RSV.

RSV, a contagious virus that can cause severe illness or death, is a common cause of respiratory illness. According to the U.S. Centers for Disease Control and Prevention (CDC), RSV infections in children younger than 5 years old result in more than 57,000 hospitalizations, 500,000 ED visits and 1.5 million outpatient clinic visits annually in the U.S.

By their second birthday, almost all children will have had an RSV infection. Deaths in this patient population are fortunately uncommon, between 100 and 500 deaths per year. In older adults, however, RSV infections cause about 177,000 hospitalizations a year—and approximately 14,000 deaths.

In 2023, the FDA has approved both vaccines and monoclonal antibodies targeting RSV. When a vaccine is administered, it stimulates the body’s own immune response to protect against a specific disease. In comparison, monoclonal antibodies provide passive immunity via laboratory-made proteins that mimic the immune system’s ability to fight infection. Both vaccines and monoclonal antibodies are considered to be immunizations.

A wealth of new treatments ­

Before this year, the last big approval for an RSV agent came on June 16, 1998, when the FDA approved Synagis for a narrow pediatric patient population. MedImmune, LLC ushered the monoclonal antibody through the approval, but the agent is now the property of Swedish Orphan Biovitrum AB, or Sobi.

Until now, there’s been a dearth of new agents for RSV. This year has seen three new treatments so far, including two vaccines for different patient populations. The first vaccine to gain FDA approval was GSK’s Arexvy, approved May 3 for the prevention of lower respiratory tract disease (LRTD) caused by RSV in people at least 60 years old. At the end of May, the FDA approved Pfizer Inc.’s Abrysvo for the same indication.

On Aug. 21, the FDA granted a second indication to Abrysvo, for use in pregnant people at 32 to 36 weeks of gestation to prevent LRTD and severe LRTD in infants from birth through six months of age. The vaccine causes the mother to produce RSV antibodies, which are then passed along to the fetus.

In addition to the vaccines, on July 17, the FDA approved AstraZeneca and Sanofi’s monoclonal antibody Beyfortus for the prevention of LRTD in neonates and infants entering their first RSV season, and in children up to 24 months old who are vulnerable to severe RSV throughout their second season. It is the first-ever immunization against RSV that’s available to all infants.

Payer coverage and health equity

Following the June 21 recommendation of the Advisory Council on Immunization Practices (ACIP)—a federal advisory committee of medical and public health experts that develops recommendations on vaccine use in the U.S. for both children and adults—the director of the CDC endorsed both Arexvy and Abrysvo for use in adults.

On July 21, the CDC’s Morbidity and Mortality Weekly Report published ACIP’s recommendations, meaning that the agents are on the official immunization schedule for adults in the U.S. These vaccines must therefore be covered without cost sharing by individual and employer-sponsored private health plans subject to the ACA’s preventive services coverage standards within one year.

Medicare Part D also will cover the vaccines, so people without that drug benefit may have to pay out of pocket for them.

ACIP also voted in favor of Beyfortus, and on Aug. 3, the CDC director adopted that recommendation. The CDC also determined that Beyfortus is eligible for inclusion in the Vaccines for Children program, which provides free vaccines for uninsured and underinsured children, who may not otherwise be vaccinated because of financial barriers.

ACIP has two more scheduled meetings in 2023: Sept. 12 and Oct. 25-27. The committee could discuss Abrysvo’s use in pregnant people at one of those meetings.

Protecting the public during RSV season

The season for RSV infections usually begins in the fall and lasts into the spring, peaking in January and February. As the end of summer approaches, the possibility of another “tripledemic”—with rising rates of RSV, COVID-19 and influenza—is all too real.

To benefit public health, both payers and manufacturers should prioritize education about how and where people can get immunized for RSV. Everybody who needs it, regardless of their insurance, should be able to access RSV protection.

For more information on vaccines, check out our first post in this series, The Path to Commercial Plan Coverage, as well as the second post, The Inflation Reduction Act’s Impact on Coverage.

© 2024 MMIT
Jayne Hornung

Jayne Hornung

Jayne Hornung is the Chief Clinical Officer at MMIT (Managed Markets Insight & Technology), a trusted go-to-market partner who believes that patients who need lifesaving therapies shouldn't face delays because accessing drugs can be confusing. She is a clinical pharmacist and has been one of MMIT’s clinical subject matter experts for the past 13 years. In her role, she conducts research of drug, indication and policy data and helps MMIT’s clients understand market access from a clinical perspective. You can find her on LinkedIn.

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