The Centers for Disease Control and Prevention (CDC) vaccine advisory group today recommended newly approved respiratory syncytial virus (RSV) vaccines for use in two older age-groups, people ages 60 to 64 and those ages 65 and older.
The Advisory Committee on Immunization Practices (ACIP) voted separately on use in the two age-groups. In the first vote, which passed 9 to 5, advisers said adults ages 65 and older may receive a single dose of the vaccine, using shared clinical decision making.
In the second vote, which passed with 13 yes votes and 1 abstention, they said individual adults ages 60 to 64 may receive a single dose of RSV vaccine using shared clinical decision making.
The CDC estimates that 60,000 to 160,000 older adults are hospitalized for RSV infections each year, with the virus leading to the deaths of 6,000 to 10,000 people each year. Those at highest risk for severe disease include those ages 65 and older, people with chronic heart and lung problems, and patients with weakened immune systems.
A new tool for respiratory virus season
In May the Food and Drug Administration (FDA) approved two RSV vaccines for use in adults ages 60 and older. On May 3 it approved GSK's vaccine, called Arexvy, which is a recombinant glycoprotein vaccine that contains the company's proprietary AS01 adjuvant. And in late May, it approved Pfizer's RSV vaccine, called Abrysvo, an unadjuvanted bivalent recombinant subunit vaccine that contains antigens against two RSV subgroups, A and B.
Both vaccines contain 120 micrograms of antigen and are given as a single intramuscular dose.
GSK today released new results on the vaccine from an ongoing phase 3 trial, which found an overall efficacy of 82.6% against lower respiratory tract disease during the first season, 77.3% for mid-season, and 67.2% over two seasons. Against severe disease, efficacy was 94.1% during the first season, 84.6% at mid-season, and 78.8% over two seasons.
The trial also looked at efficacy over two seasons in people who received a second dose and found a cumulative efficacy of 67.1%, hinting that revaccination after 12 months doesn't add extra benefit for the general population.
While it's possible they could be offered in the fall, along with the updated COVID vaccine and the annual flu shot, it's not clear how timing would work for the new RSV vaccines.
During a CDC presentation on the clinical considerations for the vaccine, officials said the ideal timing for RSV vaccine isn't clear, due to variability in the start of the RSV season. They said providers should offer the vaccine as soon as supply is available and be prepared to continue offering the vaccine throughout the season to eligible adults. Vaccine cost is expected to be $180 to $270 for Pfizer and $200 to $290 for GSK.
Before the RSV vaccines are distributed and administered, the CDC director needs to sign off on the ACIP's recommendation. The agency typically accepts the recommendations of its vaccine advisory group.