The Food and Drug Administration (FDA) recently approved an expansion of a respiratory syncytial virus (RSV) vaccine for use in at-risk adults over age 50.
GSK, the vaccine manufacturer, announced the approval Friday, making it the first vaccine stamped for adults ages 50 to 59 to protect against the virus.
“Today’s approval reflects the importance of extending the benefits of RSV immunization to adults aged 50 to 59 who are most at risk,” said Tony Wood, chief scientific officer at GSK, in a statement. “For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD.”
The pharmaceutical company Requested expansion in early February, saying its trial showed an acceptable immune response and tolerability profile in adults in their 50s. Now, GSK needs the vaccine to get a recommendation from the Centers for Disease Control and Prevention (CDC) immunization advisory committee for people in that age group.
In addition to GSK, Moderna and Pfizer also produce RSV vaccines approved for adults over 60. The FDA approved Moderna’s RSV vaccine late last month, making it the third vaccine given the green light to combat the disease, behind GSK’s Arexvy and Pfizer’s mRESVIA.
The CDC panel will also have to evaluate the possibility of needing RSV booster shots.
GSK has also submitted a regulatory application to expand the vaccine’s use in adults aged 50 to 59, with increased risks in some European countries, Japan and others.
“When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider,” Ann R. Falsey, a professor at the University of Rochester School of Medicine, said in the release. .
“Many adults in this age group have underlying health conditions that put them at increased risk for serious illness with RSV infection compared to those without these conditions,” Falsey added. “There is now an approved vaccine that can help protect them.”
This story originally appeared on thehill.com read the full story
