Replies to post #246689 on Biotech Values

[dewophile]

Approval for GSK and PFE always seemed highly likely and ACIP in June more of the wild card. Will they green light only in 65 and older vs 60, etc. The other wild card is negotiations w retailers. GSK has the upper hand this flu season bc assuming ACIP green lights for high risk adults under 65 they will be the only ones w data in 50-59 year olds (as well as all 3 flu coadministration groups regular, high dose, and adjuvenated). So it is hard for a large pharmacy chain where half or more of vaccinations take place these days to not carry the GSK product, and presumably some may only want to carry one. Next year RSV season presumably will also have moderna - PFE and GSK will have efficacy data from a second season so they will be playing from behind wrt to this, but longer term who knows how the relative market shares shake out. PFE has the edge on tolerability, GSK/MRNA efficacy, and if covid becomes an annual shot I think having a flu/covid 2 in 1 could make a difference. PFE mentioned that they are seeing good efficacy in the second season so including RSV becomes less important if that is an every 2-3 year shot vs flu/covid

[DewDiligence]

FDA approves Abrysvo—(PFE’s RSV vaccine)—for adults 60+:

https://www.businesswire.com/news/home/20230530005660/en

Today was the PDUFA date.

GSK’s similar RSV vaccine, Arexvy, was approved for adults 60+ by the FDA four weeks ago (#msg-171831470).

PFE’s separate BLA for its maternal RSV vaccine—to protect newborns for up to six months—has a PDUFA date in August 2023 (#msg-171260623) and was recently endorsed by VRBPAC (#msg-171942839). PFE is the only company with such a vaccine, as far as I know.

[DewDiligence]

Good_news_and_bad_news—GSK’s RSV vaccine protects_older_adults_for_two_seasons:

https://www.businesswire.com/news/home/20230620554754/en

This is good news for society, but probably bad news for GSK, PFE, and MRNA (the main players in the adult RSV-vaccine market). From the above PR:

The [GSK] trial also evaluated efficacy following an annual revaccination schedule as a confirmatory secondary endpoint. Cumulative efficacy over two seasons in participants who received a second dose of the vaccine was 67.1% [almost identical to the cumulative two-season efficacy of the single-dose regimen]…, suggesting revaccination after 12 months does not appear to confer additional benefit for the overall population.

[GSK’s] clinical development program will continue to evaluate longer-term follow up and the optimal timing for potential revaccination.

So, annual adult vaccinations for RSV will probably not become the SoC, which presumably means lower annual revenue for these medicines than some investors previously thought.