After GSK nabbed a coveted world-first approval for its adult respiratory syncytial virus (RSV) vaccine in the U.S., it has scored the same title in Europe with Arexvy.
The authorization covers adults 60 years and older in 30 European countries. It's backed by data from the phase 3 ARsSVIi-006 trial, which supported the shot's recent U.S. approval. In the study, the vaccine demonstrated overall efficacy of 82.6% and 94.6% in older adults with at least one underlying medical condition.
GSK’s Arexvy application was fast-tracked in Europe because of the “major public health interest” in preventing illness from RSV, the company said in a release. The European Commission's decision follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) positive opinion in April and comes earlier than expected.
The virus causes more than 270,000 hospitalizations and about 20,000 in-hospital fatalities annually in the age group across Europe, according to GSK. The company plans to launch the shot before the RSV season begins in the fall.
When GSK’s Arexvy won its approval from the FDA in May, Pfizer and its rival shot Abrysvo, was hot on its tail. Now, Abrysvo has picked up a U.S. nod as well. Pfizer will launch its shot in the U.S. on the same timeline as Arexvy this fall.
Meanwhile, both companies are waiting on recommendations from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), which will determine potential vaccination schedules.
GSK noted on its first quarter earnings presentation that it has “millions” of Arexvy doses ready to ship out. It’s still waiting on data proving the shot’s efficacy over multiple RSV seasons, but is looking at a blockbuster sales opportunity, executives have said.
Other regulatory reviews for Arexvy are ongoing in Japan and several other countries, GSK said in its release.