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RSV Vaccine for Older Patients Receives Support

By Jonathan Springston, Editor, Relias Media

The FDA has approved the first vaccine in the United States that can be administered to patients age 60 years and older to protect against serious illness caused by the respiratory syncytial virus (RSV).

RSV is a contagion that harms the lungs and breathing passages of everyone, regardless of age, and is especially bad in the fall and winter. The CDC estimates RSV hospitalizes as many as 160,000 adults older than age 60 years annually and causes as many as 10,000 deaths among the same group.

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, who called the approval “an important public health achievement.”

Researchers are testing the effectiveness and safety of the vaccine in a randomized, placebo-controlled study that is ongoing in the United States and elsewhere. Scientists recruited 25,000 people age 60 years and older into this study and will conduct this research through three RSV seasons. In its Arexvy approval, the FDA relied on data collected during the first RSV season.

Among the half of participants who received the vaccine, the solution reduced the risk of developing RSV-associated lower respiratory tract disease (LRTD) by 82.6% and lowered the risk of developing severe RSV-associated LRTD by 94.1%. The FDA granted priority review for Arexvy, but asked the manufacturer, GlaxoSmithKline (GSK), to conduct a postmarketing study to assess the risks of serious risks for Guillain-Barré syndrome and acute disseminated encephalomyelitis, a rare type of inflammation that affects the brain and spinal cord.

In June, the CDC’s Advisory Committee on Immunization Practices is expected to make recommendations on the appropriate use of Arexvy in the United States. GSK believes its vaccine will be available for the start of the 2023-2024 RSV season. “Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries,” said Tony Wood, chief scientific officer for GSK.

Investigators have been trying to find the right vaccine for RSV for decades. Earlier this year, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) signed off on Arexvy and another candidate before handing off the work to the CDC for additional review. More background on the VRBPAC’s process is in this article, which appeared in the April 2023 issue of Hospital Infection Control & Prevention.

As cold and flu outbreaks arrived in late 2022, Relias Media created this collection of commentaries, monographs, blog posts, and news pieces about RSV to help providers navigate the choppy waters of diagnosis and treatment. Even more about the virus can be found at this link.

For more on this and related subjects, be sure to read the latest issues of Hospital Infection Control & Prevention and Infectious Disease Alert, along with the “Pharmacology Update” feature that appears in each issue of Internal Medicine Alert.