FDA Approves First RSV Vaccine for Seniors

The winter of 2022-23 saw a combined surge in the number of hospitalizations resulting not only from COVID-19 and influenza infection but also resulting from RSV – especially among young children and older adults.  Respiratory Syncytial Virus (RSV) infection in seniors with underlying health conditions can lead to severe life-threatening illness.  Earlier this month, the U.S. Food and Drug Administration approved the first RSV vaccine for adults over the age of 60 – an important public health safety measure and good news for seniors. 

According to a recent FDA news release, RSV is a highly contagious virus that causes infection of the lungs and airways in all age groups.  But seniors with heart or lung disease, or a weakened immune system are at increased risk for serious illness illness affecting the lower respiratory tract.  Pneumonia and bronchiolitis (swelling of the small airways) can lead to hospitalization and death among adults over the age of 65. 

Trials leading up to the approval of Arexvy demonstrated the vaccine’s success in significantly reducing the risk of developing severe RSV symptoms by 94.1 percent, compared with a placebo.  Common side effects included injection site pain, fatigue, muscle pain, headache, and joint stiffness or pain.  Atrial fibrillation was reported in 10 study participants, out of a group of 12,500, within 30 days of receiving Arexvy and by 4 participants out of 12,500 who received a placebo.   Atrial fibrillation will be assessed in further study. 

The vaccine is expected to cost $120 per shot, according to Reuters, and the Centers for Disease Control and Prevention will discuss how often the RSV vaccine should be given at its advisory panel meeting set for late June.  The U.S. government estimates that RSV leads to 14,000 deaths annually among adults over the age of 65. 

Rare side effects in vaccine trials included two cases of Guillain-Barré, a condition in which the immune system attacks the nervous system.  GlaxoSmithKline Biologicals, the vaccine manufacturer, is required to closely monitor any incident of Guillain-Barré possibly related to the shot.  Moderna is also developing an RSV vaccine for older adults, and authorization is expected within the next few months. 

The shots could be available for older adults as soon as this fall and will be distributed at U.S. pharmacies, clinics and other healthcare settings.  Medicare patients with Part D drug coverage can receive the vaccine at no cost.   Other insurers are also likely to cover the full cost of the vaccine.