The United States Food and Drug Authority has recently approved GlaxoSmithKline’s RSV vaccine, marketed as Arexvy for preventing lower respiratory tract disease caused by Respiratory syncytial virus (RSV) in people 60 years of age and older.

The nod makes Arexvy the first RSV vaccine to be approved by any drug regulatory authority in the world.

Announcing the approval, Dr Peter Marks, the director of the FDA’s Centre for Biologics Evaluation and Research, said, “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.”

“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” he added.

RSV is a highly contagious virus that infects the lungs and breathing passageways in people of all ages. RSV circulation is seasonal, peaking in the autumn and ending in the winter. RSV is a major cause of lower respiratory tract disease (LRTD) in older persons, which affects the lungs and can lead to life-threatening pneumonia and bronchiolitis.

Available data indicate that the virus infects over 60% of infants under three months of age and is responsible for severe lower respiratory tract infections.

Similarly, a 2022 study revealed that the RSV disease burden in adults aged over 60 years in high-income countries is higher than previously estimated, highlighting the need for RSV prophylaxis in this age group.

The approval follows the FDA’s analysis of data from an ongoing, randomized, placebo-controlled clinical study conducted in the U.S. and internationally in individuals 60 years of age and older in which the vaccine significantly reduced the risk of developing RSV-associated LRTD by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%.

The FDA has requested that GSK execute a postmarketing study to analyse the signals of serious risks for Guillain-Barré syndrome and ADEM, while the company has consented to conduct a postmarketing study to assess atrial fibrillation related to the vaccine, according to the drug regulator.

Commenting on the approval, Tony Wood, Chief Scientific Officer, GSK, said, “Today marks a turning point in our effort to reduce the significant burden of RSV.”

Adding that GSK is focused on is to ensure eligible older adults in the United States can access the vaccine as quickly as possible and to progress regulatory review in other countries, Mr Wood said, “Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year,” he added.

“For decades, AMGA and the healthcare community at large have been active in finding ways to increase adult immunisations,” Dr John Kennedy, the President of the American Medical Group Association (AMGA) said.

“With this vaccine, Americans over 60, and particularly those with underlying health conditions like COPD, asthma, or congestive heart failure, will have a vaccine to help protect against potentially serious outcomes from RSV,” he added.