I agree. ACIP has really thrown curveballs at every opportunity. However the story is not close to over. Year 3 data is not out yet, next year ACIP will revisit revaccination , revisit the risk benefit with another year of data. My guess is that this ends up being an every other year vaccination story (alternatively on the off chance year 3 protection is decent then you can justify a big price increase). I also think that with more real world data the risk benefit may shift more favorably. It also makes no sense why an adult of any age at high risk of severe disease isn’t green lighted for this vaccine in due course. But this year sales could be muted for sure
Today's results indicate that after a single dose of GSK’s RSV vaccine, cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD (97.5% CI, 46.7-74.8, 48 of 12,468 vs 215 of 12,498) and 67.4% against severe RSV-LRTD (95% CI, 42.4-82.7, 15 of 12,468 vs 75 of 12,498) compared to placebo. In the third season, the vaccine’s efficacy was 48.0% against RSV-LRTD (95% CI, 8.7-72.0, 16 of 4,988 vs 61 of 10,031).
season 3 efficacy vs severe LRTD was actually lower at 43.3% vs 48% for LRTD overall, but a bit higher for those with a comorbidity at 57.8%
I'm not sure what to make of this bc there is no information here on protection with revaccination. At this point any revaccination schedule remains murky, and bc of this is a net negative. I don't think GSK can easily just increase the price of their vaccine now that they have some efficacy out to 3 years (versus 2) bc of the competitive environment and the year 3 protection is somewhat lower than years 1 and 2. This might crimp hopes for a rebound in vaccine uptake next year although there could be some upward price pressure if this is ultimately deemed a 3 year vaccine note the study is not designed to test efficacy beyond year 3 even if uptake is good we are now at 50% efficacy and dropping moving forward so any suggestion that vaccines will greatly eliminate the need for an antiviral is dropping until some data and plan/approval for revaccination emerges. The language in this PR suggests GSK doesn't see improvement in effiicacy with revaccination after 2 years or else I think they would have mentioned it in the PR. These data are being presented at a meeting today so perhaps there is more clarity soon.