Thursday, April 18, 2024

An FDA panel has recommended a 2-dose RSV vaccine for older Americans. Here’s when they might be able to get it

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A U.S. Food and Drug Administration panel Wednesday recommended two doses of an RSV vaccine for older adults, after approving an initial dose earlier this week.

The panel voted to approve a second shot against the common winter respiratory virus—sometimes severe in the elderly and the young—from Pfizer and GlaxoSmithKline. It voted Tuesday to recommend a first shot, 7–4. 

Both jabs would be available for adults 60 and older—and they could be ready as soon as this summer, Dr. Ali Alhassani, head of clinical at Summer Health, tells Fortune.

The panel’s recommendations are usually adopted by the FDA. Final approval would come from the U.S. Centers for Disease Control and Prevention.

Pfizer is also seeking approval for an RSV vaccine for pregnant individuals, to provide protection for infants from birth through the first six months of life. It showed 82% effectiveness through 90 days of life, and 69% effectiveness through six months, Pfizer announced in November, citing Phase III clinical trial data. The FDA is set to review the vaccine by August, according to the company.

RSV, or respiratory syncytial virus infection, is a common illness that usually presents as a mild cold. Almost everyone has been infected with it by age 2, according to the CDC. 

But RSV isn’t mild for everyone. The virus hospitalizes tens of thousands of infants, young children, and elderly adults each year in the U.S. And it kills between 6,000 and 10,000 elderly adults in the U.S. each year, according to the national public health agency.

Symptoms can range from cold-like ailments such as sneezing, sore throat, fever, and stuffy nose, to bronchiolitis and pneumonia, the latter of which can prove fatal. What’s more, patients can quickly take a turn for the worse. 

RSV can also exacerbate the symptoms of people with chronic health problems like asthma, chronic obstructive pulmonary disease (COPD), or congestive heart failure, according to the CDC.

Those at highest risk of a severe outcome from RSV, according to the CDC, include:

  • Older adults 65+
  • Infants 6 months and younger
  • Prematurely born infants
  • Older adults and children younger than 2 with chronic heart or lung disease
  • Older adults and children with weakened immune systems
  • Children with neuromuscular disorders, such as those who have difficulty swallowing or clearing mucus

Cases of RSV are leveling out after a spike in November. The virus, along with COVID and flu, was part of what some public health officials called a “tripledemic” late last year that put hospital capacity in jeopardy as viral circulation spiked, likely as a result of the lifting of pandemic restrictions. While the impact on the U.S. health system was significant, other factors like general hospital bed availability and a shortage of health care workers contributed, and levels of RSV were not unusually high, experts say.

While RSV is a common winter virus, it can occur at any time of year. COVID disrupted the seasonal patterns of many viruses, resulting in oddly elevated RSV levels spring through fall of 2021.

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