The U.S. Food and Drug Administration (FDA) has approved the first respiratory syncytial virus (RSV) vaccine, named Arexvy, for individuals aged 60 years and older. The FDA’s approval of the respiratory syncytial virus vaccine is a tremendous step for public health. It demonstrates how seriously the FDA supports the development of safe and effective vaccines for use in the United States.
Respiratory syncytial virus (RSV) is a viral infection that can harm the lungs and airways of people of all ages. This virus often spreads in the autumn and peaks in the winter. Lower respiratory tract disease (LRTD) causes lung damage and can lead to pneumonia and bronchiolitis, which can be fatal in the elderly if not treated quickly.
Every year in the United States, the CDC predicts that between 6,000 and 10,000 persons aged 65 and up die from complications due to RSV infection. Because RSV can be fatal, the approval of the first vaccine against it is a significant public health victory. Peter Marks, M.D., Ph.D., the FDA’s director of biologics research, has stated that “RSV can be fatal in older people or patients who already have weakened immune systems, cardiac difficulties, or lung disease.
Scientists and healthcare professionals are optimistic about the future of Respiratory Syncytial Virus (RSV) treatment as more vaccines and treatments are being developed and approved. The pharmaceutical company GlaxoSmithKline (GSK) recently received approval for their RSV vaccine in the United States. The vaccine will now move forward to receive approval in Europe, and the next step in the U.S. process is for the CDC’s Advisory Committee on Immunization Practices to make recommendations on who can receive the vaccine, how it should be given, and when it will be available to the public.
RSV is a severe respiratory illness primarily affecting young children and the elderly. Each year, thousands of children in the United States are hospitalized because of RSV, and hundreds die. Newborns are particularly at risk because their immune systems do not respond robustly to many vaccines. To protect infants, Pfizer’s vaccine for pregnant individuals is designed to transfer antibodies to newborns.
According to Mina Suh, a scientist at EpidStrategies, RSV is not a harmless illness, as many people may believe. Vaccination protects the most vulnerable, including infants and older adults. With the approval of GSK’s vaccine and the potential approval of other vaccines, healthcare professionals hope that many patients worldwide will benefit from vaccination.
The safety and effectiveness of Arexvy have been established through an ongoing, randomized, placebo-controlled clinical study conducted in the U.S. and internationally involving individuals aged 60 years and older. The primary purpose of the research was to investigate if a single dose of the vaccine was safe and effective in this population, and participants were followed for three RSV seasons to see if a booster shot was safe and effective.
The FDA examined data from the first RSV season and discovered that over 12,500 patients took Arexvy; nearly the same number got a placebo. Arexvy reduced the risk of getting RSV-associated LRTD by 82.6% and the risk of developing severe RSV-associated LRTD by 94.1%.
Although Arexvy was generally well-tolerated, some side effects were reported by participants who received the vaccine. The most common side effects were injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain. Additionally, ten participants who received Arexvy and four who received a placebo reported atrial fibrillation within 30 days of vaccination.
Two other studies involving approximately 2,500 participants aged 60 years and older were conducted. In one of these studies, two patients had acute disseminated encephalomyelitis (ADEM), a rare kind of inflammation that affects the brain and spinal cord, seven and 22 days after taking Arexvy and FDA-approved influenza vaccination, respectively.
Among the study participants, a fatal case of ADEM occurred. One person in the other study developed Guillain-Barré syndrome nine days after using Arexvy, a rare disorder in which the immune system assaults nerve cells, resulting in muscle weakness and, in severe cases, paralysis.
As a result, the FDA has directed the company to conduct a post-marketing study to assess the risks of Guillain-Barré syndrome and acute disseminated encephalomyelitis. Even though it is not a regulatory requirement, the company has agreed to include an assessment of atrial fibrillation in the post-marketing study.