Key Takeaways

The Food and Drug Administration (FDA) approved Pfizer’s vaccine againstrespiratory syncytial virus, or RSV, for adults 60 and older earlier this week.This marks the second available RSV vaccine in the United States after a version from pharmaceutical company GSK earned approval last month.

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

Record-high RSV cases collided with influenza and COVID-19 to cause what somepublic health expertscalled a “tripledemic” of respiratory illness last winter. Children were hit particularly hard; babies under a year old were hospitalized at a rate more than 10 times as high as the same point in 2019.

However, older adults are also susceptible to serious disease and death from RSV.The CDC estimates RSV is responsible for at least 177,000 hospitalizations and 14,000 deaths among U.S. adults each year.

“We’ve learned that RSV often is serious as influenza in causing serious respiratory disease in older persons year in and year out,”William Schaffner, MD, the medical director of the National Foundation for Infectious Diseases and a professor of infectious diseases at the Vanderbilt University School of Medicine, told Verywell. “So having some vaccines available for the prevention of RSV in older persons, is really a great advance.”

Results from a phase 3 clinical trial of more than 34,000 participants aged 60 and older showed a single dose of Pfizer’s vaccine was nearly 67% effective at preventing RSV cases with at least two symptoms, and 86% effective at preventing cases with at least three symptoms.

Symptoms of RSVCommon symptoms of RSV include:Runny noseDecrease in appetiteCoughingSneezingFeverWheezing

Symptoms of RSV

Common symptoms of RSV include:Runny noseDecrease in appetiteCoughingSneezingFeverWheezing

Common symptoms of RSV include:

The vaccine’s effectiveness appears on par with GSK’s RSV vaccine, which was nearly 83% effective at preventing lower respiratory disease in clinical trials.

Both companies say their vaccines will be available ahead of the next RSV season, which begins in early fall. In ameeting next month, a panel of advisors to the CDC will meet to discuss RSV vaccine recommendations to health providers.

So far, research shows both vaccine candidates are safe, with injection site pain, muscle stiffness, and fatigue listed as the most common side effects.

In an FDA meeting March 1,panelists discusseda seemingly increased risk of autoimmune dysfunction that could be related to the vaccine. In Pfizer’s clinical trial, there was one case ofGuillain-Barré syndromeand one case of a rare variant of that syndrome, calledMiller Fisher syndrome. These serious adverse events were rare, representing one case for every 9,000 participants. However, that’s higher than the one to two people per 100,000 typically diagnosed with Guillain-Barré each year.

The general consensus of the advisory committee, Schaffner said, was that this data could amount to a “statistical fluke.” The panel voted 7-4 to recommend the vaccine’s approval. Schaffner said he expects that the CDC will agree with the FDA that the vaccine is safe for older adults.

There are more RSV vaccines in the pipeline for older adults, too. Modernasaidit expects to submit data on its mRNA vaccine for RSV in seniors in the next few months. Bavarian Nordic also said it will report results from a phase 3 trial of its vaccine this year.

“Vaccines don’t prevent disease—vaccination prevents disease,” Schaffner said. “Now we have to figure out how to get these RSV vaccines out of the refrigerator and into the arms of older persons on a regular basis. That will be a challenge going forward.”

There May Be an RSV Vaccine for Infants Soon

What This Means For YouIf you are 60 and older, you will likely be able to receive an RSV vaccine this summer. Older adults will now have the opportunity to receive three new vaccines for major respiratory illnesses—an updated COVID-19 booster, an annual flu shot, and a new RSV vaccine.

What This Means For You

If you are 60 and older, you will likely be able to receive an RSV vaccine this summer. Older adults will now have the opportunity to receive three new vaccines for major respiratory illnesses—an updated COVID-19 booster, an annual flu shot, and a new RSV vaccine.

7 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Pfizer.U.S. FDA approves ABRYSVO, Pfizer’s vaccine for the prevention of respiratory syncytial virus (RSV) in older adults.Centers for Disease Control and Prevention.Respiratory syncytial virus infection: RSV-NET interactive dashboard.Centers for Disease Control and Prevention.RSV surveillance and research.Centers for Disease Control and Prevention.Respiratory syncytial virus-associated mortality (RSV-associated mortality). 2019 case definition.Walsh EE, Pérez Marc G, Zareba AM, et al.Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults.N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836Centers for Disease Control and Prevention.Respiratory syncytial virus infection (RSV): symptoms and care.Papi A, Ison MG, Langley JM, et al.Respiratory syncytial virus prefusion F protein vaccine in older adults.N Engl J Med. 2023;388(7):595-608. doi:10.1056/NEJMoa2209604

7 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Pfizer.U.S. FDA approves ABRYSVO, Pfizer’s vaccine for the prevention of respiratory syncytial virus (RSV) in older adults.Centers for Disease Control and Prevention.Respiratory syncytial virus infection: RSV-NET interactive dashboard.Centers for Disease Control and Prevention.RSV surveillance and research.Centers for Disease Control and Prevention.Respiratory syncytial virus-associated mortality (RSV-associated mortality). 2019 case definition.Walsh EE, Pérez Marc G, Zareba AM, et al.Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults.N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836Centers for Disease Control and Prevention.Respiratory syncytial virus infection (RSV): symptoms and care.Papi A, Ison MG, Langley JM, et al.Respiratory syncytial virus prefusion F protein vaccine in older adults.N Engl J Med. 2023;388(7):595-608. doi:10.1056/NEJMoa2209604

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Pfizer.U.S. FDA approves ABRYSVO, Pfizer’s vaccine for the prevention of respiratory syncytial virus (RSV) in older adults.Centers for Disease Control and Prevention.Respiratory syncytial virus infection: RSV-NET interactive dashboard.Centers for Disease Control and Prevention.RSV surveillance and research.Centers for Disease Control and Prevention.Respiratory syncytial virus-associated mortality (RSV-associated mortality). 2019 case definition.Walsh EE, Pérez Marc G, Zareba AM, et al.Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults.N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836Centers for Disease Control and Prevention.Respiratory syncytial virus infection (RSV): symptoms and care.Papi A, Ison MG, Langley JM, et al.Respiratory syncytial virus prefusion F protein vaccine in older adults.N Engl J Med. 2023;388(7):595-608. doi:10.1056/NEJMoa2209604

Pfizer.U.S. FDA approves ABRYSVO, Pfizer’s vaccine for the prevention of respiratory syncytial virus (RSV) in older adults.

Centers for Disease Control and Prevention.Respiratory syncytial virus infection: RSV-NET interactive dashboard.

Centers for Disease Control and Prevention.RSV surveillance and research.

Centers for Disease Control and Prevention.Respiratory syncytial virus-associated mortality (RSV-associated mortality). 2019 case definition.

Walsh EE, Pérez Marc G, Zareba AM, et al.Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults.N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836

Centers for Disease Control and Prevention.Respiratory syncytial virus infection (RSV): symptoms and care.

Papi A, Ison MG, Langley JM, et al.Respiratory syncytial virus prefusion F protein vaccine in older adults.N Engl J Med. 2023;388(7):595-608. doi:10.1056/NEJMoa2209604

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