THE PROBLEM: Respiratory syncytial virus (RSV) is a common virus that typically causes mild, cold-like symptoms — but it can be deadly to older adults, young children and people with chronic heart or lung disease or weakened immune systems. Each year in the U.S., 60,000 to 160,000 adults 65 years and older are hospitalized, and up to 10,000 people die each year from RSV infection, according to the Centers for Disease Control and Prevention.

THE SOLUTION: GlaxoSmithKline Biologicals SA’s (GSK) RSV vaccine, Arexvy, received approval from the FDA as the first of its kind. This vaccine has shown over 80% vaccine efficacy in preventing lower respiratory tract disease caused by RSV in individuals aged 60 and older. It is similarly effective for older adults with select underlying medical conditions that put them at higher risk for RSV disease. Arexvy has been approved in multiple countries, including the U.S., Europe, UK and Japan.

The development of Arexvy stems from a significant discovery made by scientists at the National Institute of Allergy and Infectious Diseases (NIAID). In 1984, these researchers isolated a crucial protein, known as the fusion glycoprotein or F protein, that enables the RSV virus to infect human cells. Building on this knowledge, NIAID’s Vaccine Research Center began investigating the F protein in 2006 for the development of an RSV vaccine. In 2013, NIAID scientists achieved a breakthrough by finding a new way to stabilize the F protein in its prefusion form, making it more effective in stimulating an immune response. This achievement paved the way for the creation of antibodies and vaccines, such as Arexvy, to prevent RSV disease in individuals aged 60 and older.

By bringing together cutting-edge science and innovative research, Arexvy offers a promising solution to help protect older individuals from the most severe effects of RSV-associated lower respiratory tract disease.

THE TECH TRANSFER MECHANISM: In 2013, NIAID filed a patent and published its discovery. Shortly after, Novartis applied for and signed a nonexclusive commercial license. In 2015, when Novartis sold its vaccine business to GSK, the RSV license from NIAID was transferred to GSK. To further develop the RSV vaccine, NIAID’s Technology Transfer and Intellectual Property Office negotiated two Research Collaboration Agreements with GSK. These agreements enabled fruitful collaboration between NIAID and GSK scientists.

The outcome of this collaboration was the FDA approval of Arexvy in 2023, highlighting the power of collaboration and tireless efforts of dedicated scientists. Recognizing the importance of sharing their knowledge, NIAID also nonexclusively licensed their discovery to 10 other companies. This allows these companies to develop their own RSV vaccine, diagnostics and treatment products, expanding the impact of NIAID’s pioneering research.

THE IMPACT: In 2023, Arexvy became readily available at major U.S. retail pharmacies. The vaccine became covered by most Medicare and commercial insurance plans in time for the fall and winter RSV season. The impressive sales of $1.5 billion worldwide reported by GSK on January 31, 2024, demonstrates strong demand for the vaccine. With an estimated 76.5 million people aged 60 and older in the U.S., Arexvy has the potential to make a significant positive impact. By helping to reduce the number of symptomatic RSV cases among older adults, this vaccine can help improve health outcomes and decrease hospitalizations, ultimately lightening the load on healthcare systems and lowering healthcare costs.