British drugmaker GSK has begun shipping doses of its newly approved vaccine for respiratory syncytial virus across the U.S. as it prepares for the fall vaccination season.
Company executives expressed confidence Wednesday in launching their shot Arexvy, the first approved by the Food and Drug Administration to prevent illness in older adults from respiratory syncytial virus, or RSV, infections. But they’ll face competition from Pfizer, which has also won U.S. approval for a competing vaccine.
“We believe Arexvy's profile, recommendation [will] support our market leadership and position with multibillion annual sales potential,” said Luke Miels, GSK’s chief commercial officer, on a second quarter earnings call.
The Centers for Disease Control and Prevention recently endorsed both GSK’s and Pfizer’s RSV vaccines for use in adults 60 and older. But, in making its recommendation, the agency said doctors and patients should talk about individual risks and the likely benefits from vaccination, or “shared clinical decision-making.” This category of recommendation is meant to convey that there is no default decision for everyone.
The endorsement followed FDA approval of Arexvy in early May and of Pfizer’s Abrysvo a few weeks later.
GSK expects sales of Arexvy will eventually rise to around 3 billion pounds per year. But executives told investors Wednesday that its launch will be a “steady build” and at a slower rate than its fast-selling shingles vaccine, Shingrix.
“I think we’ve been clear right from the beginning that we didn’t expect at the start to be at the same rate as Shingrix, just for the simple factor of awareness of disease,” said GSK CEO Emma Walmsley.
Arexvy will compete directly with Abrysvo, giving doctors and patients an opportunity to compare and choose between the two shots. GSK believes its shot could have an edge over Pfizer’s and highlighted its familiarity with marketing vaccines to this age group.
Arexvy, which covers both the A and B strains of RSV, reduced the risk of RSV-related lower respiratory tract disease by 83% in clinical testing among older adults. Against more severe disease, the shot was 94% effective.
Pfizer used slightly different definitions of illness severity in its trial, but the company’s shot was also found to be protective against both moderate and more severe disease.
“We are very much looking forward to a scientific battle with Pfizer, and it's something that we relish,” said Miels on Wednesday’s call. “And in the end, it's going to mean that physicians and pharmacists are better informed and patients are going to get a better vaccine.”
The company had initially indicated it would price the shot somewhere between the cost of influenza and shingles vaccines, but settled on a price around $280. Pfizer has indicated plans to price its shot between $180 and $270 a dose, according to Reuters.
GSK’s second quarter earnings showed sales increased by 10% from the same period a year ago, excluding the company’s COVID-19 products. The company is predicting an 8% to 10% bump in sales on an annual basis, according to its quarterly report.