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Beating its rivals, GSK nabs world-first approval for adult RSV vaccine Arexvy

In landing an FDA approval for its highly anticipated respiratory syncytial virus (RSV) vaccine, GSK has both beat out its market rivals and initiated its next major launch.

Wednesday, the FDA blessed GSK’s RSV shot Arexvy for use in adults over 60. It becomes the world’s first RSV immunization for adults, beating out a closely watched program from Pfizer and another late-stage candidate from Moderna.

The FDA approved the shot based on phase 3 trial data showing it was 82.6% effective at preventing RSV-related lower respiratory tract disease in adults 60 and older. Protection against severe disease in the trial came in at 94.1%.

That phase 3 trial is ongoing to examine efficacy over three RSV seasons. So far, the shot has turned in “tremendous data,” GSK’s Leonard Friedland, M.D., vice president and director of scientific affairs and public health for vaccines, said in an interview.

With the approval, GSK is stepping into “the golden age” of vaccine development with “tremendous opportunities,” Friedland said. Now, it’ll be up to the company to turn its scientific know-how into actual vaccinations.

“And that’s going to be the work of the entire company and the scientific community to make that happen,” he said.

RSV is under-recognized and under-diagnosed, so GSK hs already started its awareness efforts. Its campaign, called “Sideline RSV,” is led by former basketball star Earvin “Magic” Johnson. Friedland calls Johnson a well-regarded public health figure, particularly in getting out messages to communities of color.

GSK plans to launch its vaccine ahead of the upcoming RSV season. RSV seasons typically peak from December to February.

But the company could soon have competition as Pfizer’s rival candidate is up for an FDA decision this month. Moderna’s shot has also passed a phase 3 study, but the company has yet to submit its program to regulators.

GSK isn’t concerned about the competition. In fact, having another horse in the race would be “fantastic” as it would provide more options to patients, Friedland explained.

Meanwhile, GSK believes supply won’t be an issue as the company has prepared its production teams in anticipation of the approval.

“We’re absolutely confident that our supply will meet demand,” Friedland said.

As for pricing, the company is looking to price the shot somewhere between the cost of a high-dose flu shot (around $60) and its shingles vaccine Shingrix (around $185). GSK is also working with insurance companies to ensure the vaccine is available and reimbursable.

In addition, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to discuss RSV guidance next month.



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