The US Food and Drug Administration (FDA) has approved a new vaccine to protect against respiratory syncytial virus (RSV), which causes lower respiratory tract disease (LRTD). This is the first time that a vaccine has been approved for this purpose, and it is a significant moment that has been decades in the making. The vaccine, called Arexvy, was developed by pharmaceutical firm GSK, and has been shown to reduce the risk of getting LRTD through RSV by 82.6% in people aged 60 and older. It also reduced the risk of developing severe disease by 94.1%.
RSV is a serious health problem that affects many people, particularly those over 65 and those with underlying health conditions. In the US alone, around 14,000 people over 65 die every year due to RSV, with many more tens of thousands admitted to hospital. Very young children are also at risk if the virus takes hold, with severe infections accounting for an estimated 100 to 500 infant deaths in the US every year, and even higher numbers in developing countries.
The development of the Arexvy vaccine was spurred on by a closer analysis of the protein that RSV uses to fuse with and infect cells. Antibodies could be made from this protein, which is similar to the technique used to develop COVID vaccines in recent years. Approval for the vaccine was granted after a trial of almost 25,000 participants, with half receiving Arexvy and the other half receiving placebos.
Should it receive approval from the US Centers for Disease Control and Prevention, the vaccine would be available at pharmacies and clinics in the US by autumn. Work is already underway to get approval to administer the vaccine to people aged 50-59 as well. Other RSV vaccines, including one for pregnant women, are also in the pipeline. The estimate is that RSV costs the US around $1 billion in hospital costs every year, so this vaccine and any future ones should be able to make a significant dent in that.