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Re: DewDiligence post# 243598

Thursday, 10/13/2022 8:01:48 AM

Thursday, October 13, 2022 8:01:48 AM

Post# of 257473
GSK RSV data quite a bit better than PFE

https://www.gsk.com/en-gb/media/press-releases/gsk-s-older-adult-respiratory-syncytial-virus-rsv-vaccine-candidate/


overall vaccine efficacy of 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 vs. 40 of 12,494) against RSV lower respiratory tract disease (RSV-LRTD),



Per clinicaltrials.gov: The case definition for RSV-confirmed LRTD is as follows: Presence of lower respiratory symptoms/ signs for at least 24 hours and at least one RSV-positive swab detected by RT-PCR.


Efficacy against severe RSV-LRTD, defined as LRTD with at least two lower respiratory signs or assessed as severe by the investigator and confirmed by the external adjudication committee, was 94.1%



By contrast Pfizer data:

protection against RSV-associated lower respiratory tract illness (LRTI-RSV) defined by two or more symptoms demonstrated vaccine efficacy: 66.7%



This definition is similar to GSK's definition of severe LRTI (see above)

more severe disease primary endpoint of LRTI-RSV defined by three or more symptoms, where vaccine efficacy of 85.7%



https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-data-phase-3-trial-older

re safety all you have from the GSK PR is this

The vaccine was well tolerated with a favourable safety profile. The observed solicited adverse events were typically mild-to-moderate and transient, the most frequent being injection site pain, fatigue, myalgia, and headache.



GSK's numbers are the same in the over 70 subgroup, where they feel the adjuvant is more likely to add benefit vs non adjuvenated vaccines. We don't know yet if PFE efficacy is stat sig for those over 70

JNJ efficacy in phase 2 was as follows, w phase 3 due next year (note this is the same platform where you have cases of TTS so that is a safety overhang for them:

https://www.jnj.com/janssen-announces-phase-2b-data-demonstrating-its-investigational-rsv-adult-vaccine-provided-80-protection-against-lower-respiratory-infections-in-older-adults

vestigational RSV adult vaccine demonstrating efficacy of 80 percent (CI, 52.2-92.9%) against confirmed RSV-associated LRTD. The investigational RSV adult vaccine also demonstrated efficacy of 70 percent (CI, 42.7-85.1%) against any symptomatic RSV-associated acute respiratory infection (ARI).



This is a clear win for GSK - i am surprised the stock is not moving at all on this news

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