After a 60-year journey, the first respiratory syncytial virus vaccine was approved by the U.S. Food and Drug Administration on Wednesday, the agency said in a statement.
The vaccine is called Arexvy and was developed by Britain’s multinational pharmaceutical and biotechnology company GlaxoSmithKline, or GSK.
Arexvy is approved for ages 60 and older, and is designed to prevent lower respiratory tract disease caused by RSV.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement, “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.”
Arexvy
The scientific journal Nature said data from Phase 3 of the vaccine’s clinical trial showed there was an 82.6% reduced risk of developing lower respiratory tract disease and a 94.1% reduced risk of developing severe disease.
All participants were at least 60 years old.
CNN said the vaccine comes after the National Institutes of Health discovered the ability to freeze a certain RSV-spreading protein in the body before it fully infected other cells. Arexvy uses this “pre-fusion form of the protein, along with an ingredient called an adjuvant, which boosts immune activity.”
Barney Graham, senior adviser for global-health-equity trials at Morehouse School of Medicine in Atlanta, Georgia, was a member of the National Institutes of Health team. He told Nature, “It’s very gratifying to see this finally happening,” adding, “It’s a good day for RSV.”
The FDA statement said the most common side effect of the vaccine injection was “injection site pain, fatigue, muscle pain, headache and joint stiffness/pain.”
Ten participants who received the vaccine reported atrial fibrillation — an irregular or rapid heart rhythm — within 30 days of the injection. GSK committed to evaluate atrial fibrillation in a future study, the statement said, even though the FDA does not require it.
What is RSV?
According to the U.S. Centers for Disease Control and Prevention, RSV is a common virus that causes flu-like symptoms and is most dangerous for infants or older adults.
“In older adults, RSV is a common cause of lower respiratory tract disease, which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs),” the FDA statement said.
CNN said three other vaccines are on the way for RSV from vaccine manufacturers Moderna, Pfizer and Bavarian Nordic.