FDA approves first RSV vaccine for use in at-risk adults over 50

June 8, 2024

The Food and Drug Administration (FDA) recently approved an expansion of a respiratory syncytial virus (RSV) vaccine for use in at-risk adults over the age of 50.

GSK, the vaccine’s maker, announced the approval Friday, making it the first vaccine rubber-stamped for adults ages 50-59 to protect against the virus. 

“Today’s approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk,” Tony Wood, GSK’s chief scientific officer, said 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 the expansion in early February, saying their trial showed an immune response and acceptable tolerability profile in adults in their 50s. Now, GSK needs the vaccine to get a recommendation from the Centers for Disease Control and Prevention’s (CDC) immunization advisory committee for those in that age group.

Other than GSK, Moderna and Pfizer also produce RSV vaccines that are approved for adults older than 60 years. The FDA approved Moderna’s RSV vaccine late last month, making it the third vaccine greenlighted to fight against the disease, behind GSK’s Arexvy and Pfizer’s mRESVIA.

The CDC panel will also have to weigh the possibility of a need for RSV booster shots.

GSK has also filed a regulatory submission to extend the vaccine’s use in adults aged 50-59 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 statement.

“Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions,” Falsey added. “Now there is a vaccine approved that can help protect them.”