The U.S. Food and Drug Administration has announced the approval of a vaccine called Arexvy, making it the first-ever vaccine for respiratory syncytial virus (RSV) to be authorized for use in the United States. Dr. Peter Marks, Ph.D., hailed the FDA's decision as a significant public health milestone.
"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," Marks said.
The respiratory syncytial virus (RSV) is highly transmissible and can infect individuals of all ages, causing respiratory infections. RSV tends to circulate seasonally, typically beginning in the fall and reaching its peak during the winter months. In the case of older adults, RSV is a frequent cause of lower respiratory tract disease (LRTD), which affects the lungs and can lead to severe complications such as pneumonia and bronchiolitis (inflammation of the small airway passages in the lungs).
"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," Marks said.
According to data from the U.S. Centers for Disease Control and Prevention, RSV is responsible for an estimated 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths annually in individuals aged 65 and above in the United States.
As per a recent report from the U.S. Food and Drug Administration, a vaccine named Arexvy has been granted approval on May 3. This marks the first-ever RSV vaccine to receive approval for usage in the United States. The press release states that Arexvy has been authorized to prevent lower respiratory tract disease (LRTD) resulting from RSV in individuals 60 years and older. The FDA examined the safety and efficacy of Arexvy by analyzing data from an ongoing clinical trial, which is randomized, placebo-controlled, and being conducted in the U.S. and other countries, with participants aged 60 or above.
The primary goal of the clinical trial was to determine the safety and efficacy of administering a single dose of Arexvy to individuals aged 60 and above. The trial will be conducted over three RSV seasons to assess the duration of efficacy as well as the safety and efficacy of repeat vaccinations. The FDA's assessment was based on data from the initial RSV season of the trial, which involved administering a single dose of Arexvy. As per the press release, 12,500 participants received Arexvy while another 12,500 were given a placebo. Participants who received the vaccine saw a reduction of 82.6% in the incidence of LRTD and a 94.1% decrease in the risk of developing severe LRTD.
As reported by the Associated Press, the FDA's approval has paved the way for the RSV vaccine to be administered to individuals aged 60 and above starting this autumn. However, before deciding whether every senior should receive RSV protection or only those at high risk, the CDC's advisors are scheduled to discuss the matter in June. The report highlights that the quest for an RSV vaccine has taken decades and has been marked by repeated failures. One significant setback occurred in 1960 when an experimental vaccine worsened children's infections. Presently, there is still no RSV vaccine available for children.
