MONDAY, June 10, 2024 (HealthDay News) — The U.S. Food and Drug Administration on Friday approved the first use of a respiratory syncytial virus (RSV) vaccine for people of 50 years old who have a higher risk of the disease.
GSK pharmaceutical company’s Arexvy vaccine, as well as vaccines from Pfizer and Moderna, are already approved for use in adults 60 years of age and older, as age carries a higher risk of RSV disease.
Arexvy is the first to get the go-ahead for people ages 50 to 59 with certain health risk factors.
“A systematic review of studies in the United States showed that RSV is estimated to cause 42,000 hospitalizations each year in adults aged 50 to 64 years,” GSK said in a company statement released Friday.
“Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes, are at increased risk of serious consequences from RSV infection compared to those without these conditions.” conditions,” the company added. “RSV can exacerbate these conditions and lead to pneumonia, hospitalization or death.”
Experts at the U.S. Centers for Disease Control and Prevention (CDC) are expected to meet in June and October, at which time they could also approve the use of Arexvy in people in their 50s. Doing so would give the green light to insurance coverage.
According to CBS News, Pfizer and Moderna are also testing their RSV vaccines for use in younger patients.
The safety profile of Arexvy among people in their 50s appears to be similar to that of older people. Less than 10 percent of people in their 50s who received the injections had any reactions, GSK said, and the most common were pain at the injection site, fatigue, muscle pain and headache.
According to CBS News, the CDC advisory panel has been weighing the risk of a neurological condition, Guillain-Barré syndrome (GBS), which is seen in very rare cases after RSV vaccination. The CDC sets the rate of GBS at 1.5 cases per million doses.
Data from GSK’s latest trial did not reveal any “concerning” trends in GBS cases in the 50-59 age group, Dr. Phil Dormitzer, senior vice president and global head of research and development at GSK, told CBS News. GSK vaccines.
“The risk of GBS tends to increase, it’s another one of those risks that tends to increase, with age. But there’s nothing to indicate that there is a particular risk of GBS,” he said.
New data will be presented to the CDC this month on the spacing of RSV booster shots for older adults, Dormitzer said.
“This is a really key question,” he said. “At first, people anticipated that it might be an annual immunization. But then we discovered that the duration of protection actually lasts more than one season, clearly.”
Trials looking at the use of Arexvy in people aged 18 to 49 are expected to be conducted in the second half of the year, GSK said.
More information
Learn more about RSV in older adults from the CDC.
SOURCES: GSK, press release, June 7, 2024; CBS News
