The US Food and Drug Administration (FDA) has approved the world’s first vaccine for respiratory syncytial virus (RSV), officials announced Wednesday.
Called Arexvy and developed by GlaxoSmithKline (GSK), the vaccine is authorized for those over 60 years old, marking a huge turning point in the decades-long search for a shot against RSV – an illness that kills upwards of 6,000 Americans each year.
RSV is a common and highly contagious respiratory illness, which, for most people, presents as a mild cold. However, for certain groups of people – including young children, the elderly, and those with underlying health conditions – it can be serious or even deadly. According to the Centers for Disease Control and Prevention (CDC), up to 160,000 older people in the US are hospitalized due to an RSV infection each year, and up to 10,000 die.
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening.”
The quest to find a vaccine has been ongoing since the 1960s. In that time, numerous companies have developed and trialed RSV vaccines, but GSK’s is the first to be approved anywhere in the world. It still needs to be given the green light by the CDC before it can be rolled out across the country, but GSK is confident this could happen before the winter RSV season starts in a few months.
The approval comes off the back of a phase 3 clinical trial, which found that Arexvy reduced the risk of developing RSV-associated lower respiratory tract disease by 82.6 percent and the risk of severe illness by 94.1 percent in people aged over 60. The trial is ongoing, and participants will remain in the study for three RSV seasons in total, to assess the vaccine’s efficacy and safety over time.
Side effects were mostly mild or moderate, and included pain around the injection site, fatigue, muscle pain, headache, and joint stiffness/pain.
Two other, much smaller, studies, however, have hinted there may be some more severe side effects. In one study, two participants developed acute disseminated encephalomyelitis – a rare type of inflammation that affects the brain and spinal cord – after receiving Arexvy alongside an influenza vaccine. In the other, one person receiving the vaccine developed Guillain-Barré syndrome – a rare disorder in which the body’s immune system damages nerve cells.
The FDA will require GSK to conduct a post-marketing study to assess these potential risks, which the company has agreed to. It has also committed to assessing the potential risk of atrial fibrillation.
“Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries,” Chief Scientific Officer at GSK, Tony Wood, said in a statement.