By IDSE News Staff
The first respiratory syncytial virus (RSV) vaccine, adjuvanted (Arexvy, GSK) has been approved for use in the United States by the FDA, according to an agency release.
The FDA approved the vaccine for the prevention of lower respiratory tract disease (LRTD) resulting from RSV in adults who are 60 years of age and older.
The circulation of RSV is seasonal, according to the FDA, and cases typically begin appearing during the fall and peak in the winter months. RSV is a common cause of LRTD among older adults and can lead to life-threatening pneumonia and bronchiolitis.
In the United States, approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths are caused by RSV annually among adults who are 65 years and older.
The FDA analyzed the safety and effectiveness of the RSV vaccine based on data from an ongoing randomized, placebo-controlled clinical study in individuals 60 years and older (ClinicalTrials.gov Identifier: NCT04886596). The AReSVi-006 phase 3 trial was designed to assess the safety and effectiveness of a single dose administered to older adults.
In the study, roughly the same number of participants received the RSV vaccine and placebo (n=~12,500). The vaccine was shown to significantly reduce the risk for developing RSV-associated LRTD by 82.6% compared with placebo (96.95% CI, 57.9%-94.1%; 7/12,466 vs. 40/12,494, respectively). In addition, there was a 94.1% risk reduction for developing severe RSV-associated LRTD (95% CI, 62.4%-99.9%; 1/12,466 vs. 17/12,494, respectively).
“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,” said Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research. “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.”
The Advisory Committee on Immunization Practices will make its recommendations on the appropriate use of the vaccine in June 2023, according to a press release from GSK.
Internationally, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the vaccine for the prevention of RSV-associated LRTD in older adults. A final regulatory decision concerning the use of the vaccine in Europe is expected within the coming months. Additional reviews are pending in Japan and several other countries, according to the company.
“For decades, American Medical Group Association and the healthcare community at large have been active in finding ways to increase adult immunizations. As a result, we are pleased that we can now add a respiratory syncytial virus vaccine to providers’ options for patient care,” John Kennedy, MD, the president of the American Medical Group Association, in New York City, said. “With this vaccine, Americans over the age of 60, and particularly those with underlying health conditions like COPD [chronic obstructive pulmonary disease], asthma or congestive heart failure, will have a vaccine to help protect against potentially serious outcomes from RSV.”
The company said the vaccine will be available for older adults before this year’s RSV season.
Based on agency and company materials.
