A New Vaccine Could Save the Lives of Over 6,000 Older Adults Each Year

The U.S. finally has a vaccine to prevent thousands of cases respiratory syncytial virus (RSV).

The Food and Drug Administration (FDA) has approved the first-ever RSV vaccine, called Arexvy, for adults age 60 and older.

Clinical trial data from pharmaceutical company GSK, who manufactures Arexvy, shows the vaccine is highly effective at preventing severe lower respiratory tract disease in adults age 60 and older.

Researchers concluded that out of 12,467 participants who received a single dose of the vaccine, only 7 people contracted lower-respiratory tract disease compared with 40 cases confirmed in the comparable control group, preventing illness in 82.6% of recipients.

“This is absolutely an important advancement,” Dean L. Winslow, MD, professor of medicine in the division of infectious diseases and geographic medicine at Stanford University, told Verywell via email. “If 8,000 older adults die of RSV each year in the US, a vaccine with just 80% efficacy would save 6,400 lives.”

What Is RSV?

RSV is a common seasonal virus that typically circulates along with the flu during the fall and winter months. It can cause symptoms like runny and stuffy nose, coughing, wheezing, and fever. Similar to the common cold, many people contract RSV during the year, and the majority of people recover on their own. However, RSV can lead to severe illness and complications in vulnerable populations, including young children, infants, and adults over the age of 65. 

According to the Centers for Disease Control and Prevention (CDC), the annual burden of disease is greatest in these high-risk populations:

• 58,000–80,000 hospitalizations in children younger than 5 years old
• 60,000–160,000 hospitalizations in adults over age 65
• 6,000–10,000 deaths among adults over age 65
• 100–300 deaths in children under age 5

RSV infections in both children and older adults have been significantly higher this year due to the lifting of COVID precautions, like masking and social distancing. While experts are unsure if rising influenza and RSV rates will return to normal next year, an RSV vaccine for vulnerable populations would significantly decrease hospitalizations and deaths from severe RSV symptoms and disease. 

How an RSV Vaccine Can Protect Older Adults

An RSV infection is usually accompanied by flu and cold-like symptoms. A healthy adult will typically recover from RSV by resting at home for a couple of days. But for adults over 65, especially those with an underlying medical condition (like heart and lung disease), an RSV infection can prove to be deadly. That’s because it increases the risk of:

• Pneumonia 
• Severe asthma symptoms
• Worsening symptoms for people with chronic obstructive pulmonary disease (COPD)
• Congestive heart failure 
• Weakened immune system

GSK's vaccine is designed to reduce severe disease and protect adults over 60 for a full RSV season. Clinical data from the study showed a 94% efficacy rate in older adults with at least one underlying medical condition. 

“We expect that an approved RSV vaccine for older adults will help lower the rate of severe disease and subsequent hospitalization and death and reduce the significant global burden of RSV,” Temi Folaranmi, MD, MPH, vice president and vaccines therapeutic area head, U.S. Medical Affairs for GSK, told Verywell via email. “During our clinical trial, the vaccine provided protection for more than half a year, which supports its potential to protect people over at least one entire RSV season. GSK is conducting additional research to determine the annual vaccine schedule and potential longer-term protection over multiple seasons.”

Does the Vaccine Have Any Side Effects?

Among the clinical trial participants who received Arexvy, the most commonly reported side effects included:

• Injection site pain
• Fatigue
• Muscle pain
• Headache
• Joint stiffness/pain

Ten vaccinated participants (and four who received placebo) reported atrial fibrillation (AFib) within 30 days of receiving the shot.

The FDA's approval is contingent on a postmarketing study to determine the risk of Guillain-Barré syndrome and acute disseminated encephalomyelitis (ADEM), a rare type of inflammation that of the brain and spinal cord.