After decades, the US Food and Drug Administration approved GSK's 60-plus jab.
First US-approved RSV vaccine was Arexvy. Arexvy should protect seniors from RSV.
According to FDA Center for Biologics Evaluation and Research director Peter Marks, M.D., Ph.D., the elderly, especially those with heart or lung disease or impaired immune systems, are at risk for severe RSV disease. The FDA noted "today's approval of the first RSV vaccine is an important public health achievement to prevent a life-threatening disease, and it reflects the FDA's continued commitment to facilitating the development of safe and effective US vaccines." RSV infects all ages. Winter is peak viral. RSV-induced pneumonia and bronchiolitis kill seniors. RSV kills 6,000–10,000 elderly Americans after hospitalization, according to the CDC.
A randomized, placebo-controlled clinical trial in US and foreign over-60s was used by the FDA to evaluate Arexvy's safety and efficacy. Seniors received one Arexvy dosage in the first study. Three RSV seasons will evaluate vaccine efficacy, safety, and repeatability. The FDA evaluated Arexvy's first RSV dose. 12,500 Arexvy and placebo were given. Arexvy decreased RSV-associated LRTD by 82.6 percent and severe LRTD by 94.1 percent against placebo.
Arexvy's most prevalent side effects were injection-site soreness, tiredness, muscular pain, headache, and joint pain or stiffness. 10 Arexvy and 4 placebo users developed atrial fibrillation 30 days after vaccination. 2,500 60-year-olds received Arexvy. Two Arexvy and flu vaccine patients had rare brain and spinal cord inflammation, acute disseminated encephalomyelitis (ADEM), seven and 22 days later. ADEM fatality. Another research participant developed Guillain-Barré syndrome nine days after receiving Arexvy.
The FDA requires postmarketing research on Guillain-Barré syndrome and ADEM. Examine atrial fibrillation after release. FDA-approved GlaxoSmithKline Biologicals Arexvy.
