FDA expands approval for GSK's RSV vaccine to cover younger at ...

The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50.

Arexvy, which was the first RSV vaccine approved, now becomes the first to be available to adults under the age of 60 who are not pregnant. Prior to this FDA decision, Arexvy was licensed for use in people 60 and older.

“Today’s approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk,” GSK’s chief scientific officer, Tony Wood, said in a statement. “For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them.”

Ann Falsey, a professor of medicine from the University of Rochester School of Medicine who has studied RSV in adults for years, applauded the decision, saying younger adults who have underlying medical conditions are also at high risk of developing lower respiratory tract disease if they contract RSV.

“When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider,” she said in a statement circulated by the company. “Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions.”

Falsey has consulted with a number of companies that have worked on RSV products, and has been a paid consultant for GSK on Arexvy, which has been licensed for use in people 60 and older in over 40 countries.

The company estimated that 13 million Americans in their 50s have a medical condition that increases their risk of developing severe illness if they contract RSV. Those conditions include chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes.

The Centers for Disease Control and Prevention will need to recommend use of the vaccine in this age group before insurance companies will be required to cover the cost of the vaccine for people 50 to 59 years old. The CDC’s vaccines advisory panel, the Advisory Committee on Immunization Practices, is scheduled to discuss and hold votes on issues related to RSV vaccines when it next meets on June 26.

“The data supporting this regulatory submission have been submitted to CDC at their request for further review and to inform a potential ACIP recommendation. Based on the draft agenda of the June ACIP meeting, we expect the topic to be covered by the committee at the June meeting,” a GSK spokesperson said via email.

RSV can be contracted at any age, but in healthy adults an infection generally manifests as a bad cold. In young children, especially infants, and the elderly, however, an infection can be much more severe. The CDC estimates that between 60,000 and 160,000 adults aged 65 and older are hospitalized in an average year for RSV and between 6,000 and 10,000 die from the infection.

RSV long defied the efforts of scientists to devise safe and effective vaccines to protect against it. But in recent years a scientific breakthrough has resolved the problem. There are now three licensed vaccines for older adults and one for pregnant people, along with two monoclonal antibody treatments to protect infants.

Pfizer, which makes a competitor RSV vaccine, Abrysvo, markets that vaccine to adults 60 and older and to pregnant people late in gestation so that they can develop antibodies that will arm their babies against RSV in the first months of life. Pfizer announced in April that it too would file for a license extension, asking to be able to market the vaccine to adults 18 and older with health conditions that put them at high risk of severe illness if they contract RSV.

More recently, the FDA approved a third RSV vaccine for adults, Moderna’s mResvia. It also needs a recommendation for use from the ACIP and the CDC before insurance companies will be required to pay for it. The tentative agenda for the ACIP’s June meeting indicates there will be more than one RSV vote, and Moderna is scheduled to make a presentation at that meeting.