FDA approves first RSV vaccine

a nurse preparing a vaccine for administration

Drug makers have been racing at a breakneck pace to develop respiratory syncytial virus (RSV) vaccines this year. On May 3, the U.S. Food and Drug Administration (FDA) announced it has approved Arexvy, the first-ever RSV vaccine for individuals 60 and over.

The FDA’s greenlighting of GlaxoSmithKline’s (GSK) Arexvy vaccine signals the first company to reach the finish line and successfully get a product to market. 

“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, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”

What is RSV?

RSV is a little known but highly contagious upper respiratory disease that can be very dangerous for older patients, as well as in the pediatric space. While RSV occurs seasonally, it puts a distinct strain on hospitals, especially with the rise of COVID-19 coupled with ever-present annual flu seasons. 

“According to the U.S. Centers for Disease Control and Prevention, each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 and older,” the FDA explained in their press release. 

The efficacy of Arexvy is promising, as well. As the FDA stated, during the clinical trials of the vaccine, “Among the [12,500] participants who have received Arexvy and the [12,500] participants who have received a placebo, the vaccine significantly reduced the risk of developing RSV-associated LRTD by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%.”

The development and greenlighting of Arexvy are exciting, but there is still more work to do in the RSV vaccine space. Companies are still working on a safe and effective infant pediatric RSV vaccine, as well as for other age groups. RSV is currently the leading cause of hospitalization in infants, so the need for vaccine development is still high. 

Undoubtedly, however, the development of Arexvy has lit a fire under other RSV vaccine developers. It will be interesting to see what the rest of the year offers when battling this virus.

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