GSK’s vaccine for respiratory syncytial virus (RSV) has been approved by the US Food and Drug Administration (FDA) for individuals aged 60 years and above. This marks the first RSV vaccine to gain regulatory approval worldwide, and researchers are celebrating.
According to data from phase III clinical trials submitted by GSK, the vaccine, sold as Arexvy, reduced the risk of developing lower respiratory tract disease from RSV by 82.6% and severe disease by 94.1% in individuals aged 60 years and above.
This approval is significant in addressing the public health need for RSV disease prevention, especially among older adults at high risk of RSV-related complications.
A life’s work
Last November, when the United States was dealing with a surge of people with RSV, influenza, or COVID-19 flooding hospitals, the FDA hastened the approval of GSK’s vaccine. The vaccine for RSV has been in development for nearly 60 years, with the first 20 years dedicated to developing a safe vaccine. The original vaccine contained an inactivated RSV virus, but the vaccine research community shifted its strategy over time.
In 2008, researchers discovered that protein F, a molecule on the virus’s surface, was used to infect human cells. With this knowledge, protein-based RSV vaccines could be developed to introduce the molecule into cells to produce an immune response. However, early versions of this vaccine were designed around the incorrect form of protein F.
The researchers eventually found a way to target the correct form of protein F, which elicited neutralizing antibodies. Their work paved the way for companies like GSK, Pfizer, and Moderna to develop the RSV vaccines in the pipeline today.
The approval of GSK’s vaccine is a significant milestone in addressing the public health need for RSV disease prevention, especially among older adults at high risk of RSV-related complications.
The race continues
Scientists are optimistic that the approval of GSK’s vaccine will pave the way for other vaccines to be developed and approved. Pfizer and Moderna have also developed their own RSV vaccines, which are currently under expedited review by the FDA. Pfizer’s vaccine for pregnant people will be considered by an FDA advisory panel on May 18th.
It could reduce severe lower respiratory tract illnesses in infants up to 90 days old by 81.8% if approved. Babies and older adults are at high risk for RSV, which hospitalizes thousands of children in the US each year and causes hundreds of deaths.
Vaccinating pregnant people is one way to protect newborns, whose immune systems do not respond well to many vaccines. GSK’s vaccine is expected to be approved in Europe soon.
It will be reviewed by the CDC’s Advisory Committee on Immunization Practices in June to determine who can receive the vaccine and when it will be available to the public. Vaccination is key to preventing RSV-related complications and saving lives.