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

The U.S. is one step closer to preventing thousands of cases respiratory syncytial virus (RSV). Pharmaceutical company GSK recently published data confirming its RSV vaccine is highly effective at preventing severe lower respiratory tract disease in adults age 60 and older.

The results, which were published this month in the New England Journal of Medicine, are the first RSV vaccine findings to be reinforced and solidified by the peer review process (a critical step in gaining the approval of the scientific and medical community). 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

The vaccine tested in the GSK clinical trial 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 candidate 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.”

When Will an RSV Vaccine Be Available?

Publishing results in a peer-reviewed journal is a critical step in gaining approval by the Food and Drug Administration (FDA) for public consumption of a new vaccine. During the peer review process, the study was scrutinized and analyzed by experts in the same field to determine its scientific credibility.

The next step in getting the RSV vaccine to the public includes a thorough discussion of the study’s clinical data at the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting which will be held on March 1, according to Folaranmi.

If the committee finds the data to be safe, effective, and an appropriate use of a vaccine, then it will pass it along to the FDA for final approval. If all goes well, Folaranmi said that a final FDA approval could come as soon as May 3.

“We are on track to deliver one of the first RSV vaccines for older adults in 2023, ahead of this year’s RSV season, pending regulatory approvals,” Folaranmi said. “Depending on approval, we hope to launch as quickly as possible, ahead of the 2023 RSV season starting in fall.”

What About RSV Vaccines for Other Groups?

While GSK’s research is the first clinical trial for an RSV vaccine in older adults to be published in a peer-reviewed journal, other RSV clinical trials are also underway for children and pregnant mothers. Their results are promising, too:

• Pfizer’s maternal RSV vaccine showed an 82% effective rate at preventing severe disease in babies under 3 months old.
  
• Pfizer’s RSV vaccine for older adults is in phase 3 clinical trials, and has demonstrated an 86% effective rate at preventing severe disease in those over 60.
  
• AstraZeneca and Sanofi are developing a single-dose vaccine to prevent severe disease in high-risk infants from birth to 2 years old. Clinical data shows it has an 80% efficacy rate.