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Arexvy: The First Respiratory Syncitial Virus (RSV) Vaccine Approved by FDA

by Dr. Trupti Shirole on May 7, 2023 at 10:39 PM
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Highlights:

The world's first Respiratory Syncitial Virus (RSV) vaccine has been approved by the Food and Drug Administration. Arexvy is an injection that is intended to prevent RSV. The vaccine's licensure is now limited, but it is expected to have widespread benefits (1).

Battle Against RSV and the Quest for Prevention and Treatment

Every year, around 14,000 people die as a result of RSV infection. Doctors have no method to prevent or treat until today (2). At Lurie Children's Hospital, Bill Muller, M.D., Ph.D., is an infectious disease specialist. "It can be very frustrating," he said. "We see these big surges in the wintertime."

Introducing Arexvy, the Breakthrough RSV Vaccine for High-Risk Adults

Scientists have been conducting studies for decades. Arexvy has arrived following lab tests and clinical studies. So far, the vaccine has been licensed for persons aged 60 and up, a high-risk group heavily afflicted by RSV. "In the older age group, RSV is also a threat and I think it's a little under-recognized," Muller said. "So even though the percent of adults that are infected with RSV, and the percent that go to the hospital for it, are low, the overall numbers are higher than they are in children."


Arexvy's Efficacy in Underlying Illnesses and the Potential Impact on RSV Season

The vaccination has a 94.6% effectiveness rate in persons with underlying illnesses. The overall efficacy was 82.6%.

‘The FDA has given its stamp of approval to Arexvy, a game-changing vaccine against RSV. With high efficacy and the potential to transform the prevention, Arexvy brings hope in the battle against respiratory syncytial virus. #RSV #VaccineBreakthrough’

"We also think of conditions which compromise your immune system," Muller said. "So things like cancer. But I would caution that this vaccine wasn't studied in that population. You would hope it would be helpful but we don't know that yet."

With around 177,000 infections per year in the United States, the RSV season in 2023-2024 should be drastically different. "It's the first step toward what we hope to be more approvals for RSV interventions," Muller said.

References:


  1. FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine - (https:www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine)
  2. Global Disease Burden Estimates of Respiratory Syncytial Virus-Associated Acute Respiratory Infection in Older Adults in 2015: A Systematic Review and Meta-Analysis - (https:europepmc.org/article/med/30880339)
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