FDA Approves World’s First Respiratory Syncytial Virus (RSV) Vaccine
A single dose of Arexvy reduced the risk of developing severe RSV-associated respiratory disease by 94.1 percent
The U.S. Food and Drug Administration recently approved GlaxoSmithKline (GSK) Biologicals’ Arexvy vaccine, making it the first vaccine for respiratory syncytial virus (RSV) available in the US. Arexvy is approved for individuals 60 years of age and older for preventing severe RSV infection.
RSV is a common and highly contagious virus that, upon infection, causes cold-like symptoms. But in older adults and infants, it may lead to bronchiolitis, pneumonia, and other serious lower respiratory tract diseases (LRTD). According to the CDC, RSV leads to approximately 60,000–120,000 hospitalizations and 6,000–10,000 deaths among adults 65 years of age and older each year in the US.
Efficacy and safety of the RSV vaccine
The safety and effectiveness of a single dose of Arexvy are based on the results of an ongoing, randomized, placebo-controlled clinical trial conducted in the US and internationally in individuals 60 years of age and older. The study showed that a single dose of Arexvy significantly reduced the risk of developing RSV-associated LRTD by 82.6 percent.
The most common side effects in individuals who received Arexvy include the following:
Soreness at the injection site
However, a few cases of severe side effects—like atrial fibrillation, acute disseminated encephalomyelitis (ADEM), and Guillain–Barré syndrome—were reported in this and similar studies. Therefore, the FDA requires that GSK plc conduct a postmarketing study to assess the risks for Guillain-Barré syndrome and ADEM.
“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a recent press release.