The Food and Drug Administration (FDA) recently approved an expansion of a respiratory syncytial virus (RSV) vaccine for use in high-risk adults over 50 years of age.
GSK, the maker of the vaccine, announced this approval As of Friday, this will be the first vaccine to be rubber 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 at increased risk,” GSK Chief Scientific Officer Tony Wood said in a statement. “For people 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 (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 years of age. The FDA approved Moderna's RSV vaccine late last month, making it the third vaccine to get the green light to fight the disease, following 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 applied to regulators 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,” said Ann R. Falsey, professor at the University of Rochester School of Medicine , in the statement. .
“Many adults in this age group have underlying health conditions that put them at increased risk for serious illness with RSV infection compared to people without these conditions,” Falsey added. “Now a vaccine has been approved that can help protect them.”
