As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing.
In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. And now—well in advance of the fall and winter RSV season—Arexvy is available in major U.S. retail pharmacies, GSK said Thursday.
Under the Inflation Reduction Act, Medicare Part D patients will pay no out-of-pocket expenses for the shot, GSK said. Additionally, under the Affordable Care Act, patients with commercial insurance may be covered when Arexvy is administered in-network, GSK said.
In June, the Advisory Committee on Immunization Practices (ACIP) recommended that people 60 and older decide in consultation with their healthcare provider whether to receive the RSV vaccine.
As people age, their immune systems can become compromised, making them more vulnerable to RSV infection and developing pneumonia.
Of the 76 million people in the U.S. 60 and older, those with medical conditions such as heart disease, lung disease or diabetes are at increased risk of hospitalization from RSV. Each year, roughly 177,000 Americans are hospitalized and 14,000 die from an RSV infection.
“We are hopeful that RSV vaccines, like Arexvy, will help reduce the considerable clinical, economic, and human impact that RSV has on older adults and our public health system,” Rob Truckenmiller, GSK’s head of vaccines in the U.S., said in a release.
GSK has also been quick on the trigger with a marketing campaign. Its “Sideline RSV” push features basketball legend Earvin “Magic” Johnson.
The RSV vaccine market is one of the pharma industry’s next major battlegrounds, with analysts pegging the potential opportunity at more than $10 billion annually.
Pfizer gained an FDA endorsement for its RSV vaccine, Abrysvo, in early June and began distributing shots to pharmacies and integrated delivery networks last month, the company said in an email.
In late June, Pfizer gained the same tepid ACIP recommendation as GSK for use in people 60 and older. For both companies, there was some hesitance by the ACIP to wholeheartedly endorse the vaccines for people 65 and older because trial enrollment numbers were low for the age group.
Another concern was the uncertainty of receiving RSV vaccines along with COVID-19 and flu shots. Since they are all set to be administered in the same general time frame, some on the committee wondered whether their responses could be compromised.
Moderna also has run a successful phase 3 RSV vaccine trial and has initiated a rolling submission process with the FDA for the approval of its shot in adults 60 and older.
As for the infant population, the FDA in July gave a thumbs-up to Sanofi and AstraZeneca’s RSV antibody, Beyfortus, for infants and toddlers up to 24 months of age. Pfizer is waiting on its own maternal vaccination approval to protect infants in the U.S., with a decision expected this month.

Reference: https://www.raps.org/News-and-Articles/News-Articles/2023/8/Recon-Appeals-court-ruling-would-limit-access-to-a