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FDA approves first RSV vaccine for older adults

Respiratory syncytial virus, 3D illustration which shows structure of virus of two types of surface spikes.
Dr_Microbe
/
stock.adobe.com
This illustration shows the respiratory syncytial virus, or RSV.

After decades of trial and error, the first vaccine for the respiratory syncytial virus, or RSV, is expected to hit the shelves by the fall.

The FDA approved GSK’s vaccine, Arexvy, on Wednesday for the prevention of lower respiratory tract disease caused by RSV in people 60 and older.

In a statement, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, called the approval “an important public health achievement to prevent a disease which can be life-threatening.”

The FDA reported that GSK’s clinical trial data showed an 82.6% efficacy rate in reducing the risk of getting the disease, and a 94.1% chance at preventing severe illness.

UR Medicine’s Dr. Edward Walsh and his team weren’t part of developing GSK’S RSV vaccine, but they have been doing research on developing one since the 1980s.

Walsh said it’s only within the past decade or so that researchers began seeing some promise.

“It's very satisfying that we've been able to watch this evolve,” said Walsh, an infectious disease specialist.

“It's been a long haul, and it's not done yet,” he added. “There's still a lot of information we still need to garner.”

He said while this win is significant, the real efficacy test will come when the vaccine is made available to the public.

“We now look at sort of the real-world effectiveness of these vaccines,” Walsh said.

The GSK vaccine, which is a fusion protein vaccine, also has a molecule that helps boost the immune system, which Walsh said is particularly beneficial for older adults.

Each year, the Centers for Disease Control and Prevention estimates that between 60,000 to 160,000 older adults in the United States are hospitalized with RSV, and roughly 10% of them die due to the illness.

This vaccine, although new, was developed using the same technique that is used to produce polio and flu vaccines and not with the newer mRNA technology used with the COVID-19 vaccine. Walsh said he hopes this standard approach will eliminate any hesitancy.

"The technology that's used, although it's quite sophisticated, is really producing a vaccine sort of the old-fashioned way,” Walsh said. “That should be somewhat reassuring to some people.”

Walsh said Pfizer and Moderna’s versions of the vaccine should be next for approval. He said Moderna's vaccines is mRNA-based but is just as effective.

Racquel Stephen is WXXI's health, equity and community reporter and producer. She holds a bachelor's degree in English literature from the University of Rochester and a master's degree in broadcasting and digital journalism from the S.I. Newhouse School of Public Communications at Syracuse University.