FDA considers extending RSV vaccine to adults in their 50s

Photo: AlexandruPavalache EyeEm/Getty Images

Vaccinations for respiratory syncytial virus (RSV), an upper respiratory virus that typically thrives in colder weather, may soon extend to adults in their 50s thanks to a priority review granted by the U.S. Food and Drug Administration.

If the FDA ultimately approves the vaccine, manufactured by drugmaker GSK, it will be the first RSV vaccine available for adults ages 50-59. A final decision from the federal agency is expected by June 7. AREXVY is currently approved in the U.S. in adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV.

GSK used a Priority Review Voucher to reduce the FDA review period of a supplemental Biologics License Application (sBLA) by four months.

The application is supported by positive results from a phase III trial evaluating the immune response and safety of the vaccine in that age group, including those at increased risk for RSV-LRTD due to underlying medical conditions. 

According to data cited by GSK, the burden of RSV disease in adults is likely to be underestimated due to lack of awareness, a lack of standardized testing, and under-detection in surveillance studies. People with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, chronic heart failure and diabetes are at increased risk for RSV disease. RSV can exacerbate these conditions and lead to pneumonia, hospitalization or death.

WHAT'S THE IMPACT?

RSV is a common contagious virus affecting the lungs and breathing passages. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age, according to the Centers for Disease Control and Prevention.

Each year, about 177,000 adults 65 and older are hospitalized in the U.S. due to RSV; an estimated 14,000 cases result in death.

In addition to already being approved for those 60 and over, the vaccine has also been approved for the prevention of RSV in that age group in Europe, Japan, U.K., Canada and several other countries. Regulatory reviews in multiple countries are ongoing. The proposed trade name remains subject to regulatory approval in other markets.

THE LARGER TREND

RSV was one of the viruses, along with COVID-19 and the flu, that caused hospital officials in Fresno County, California, in December to warn of severe working conditions and urge the public to avoid checking into the emergency room for nonemergency issues.

Calling the number of admitted patients "historic," Fresno County Emergency Medical Services Director Dan Lynch said hospitals in the county are holding admitted patients in the ER for up to four days and are using conference rooms and other non-patient areas to hold patients.

RSV has led to more pediatric emergency hospitalizations than the flu and the Omicron variant of COVID-19, according to January findings in JAMA. Retroactively analyzing data from about 500,000 under-18 patients from August 2021 to September 2022, researchers found that the hospitalization rate for children testing positive for RSV was 81.7%. That compares to 31.5% for Omicron and just 27.7% for the flu.

Jeff Lagasse is editor of Healthcare Finance News.
Email: jlagasse@himss.org
Healthcare Finance News is a HIMSS Media publication.