The @JNJNews vaccine FDA briefing documents are out, so we now can see how well this single adenovirus vector vaccine dose works
fda.gov/media/146217/d…
1. It is efficacious, overall 66%, but not as high as the mRNA vaccines (even in US with D614G strain).
fda.gov/media/146217/d…
1. It is efficacious, overall 66%, but not as high as the mRNA vaccines (even in US with D614G strain).
2. While 85% efficacy was seen for severe infections, there was some falloff in participants > 60 yrs of age
3. A look at asymptomatic infections (carrier state) suggests the efficacy for reducing that is similar to overall efficacy
4. There was a notable impact in efficacy by variants, geography of participants
5. Protection from death or hospitalizations was incomplete
6. More on deaths or hospitalizations (post hoc analysis)
All 7 covid deaths in placebo arm, but hospitalizations did occur in vaccine arm before 28 days, thereafter were all prevented
All 7 covid deaths in placebo arm, but hospitalizations did occur in vaccine arm before 28 days, thereafter were all prevented
7. Overall solid evidence of safety, 1 Guillian-Barre, unresolved, a couple of facial paralysis events resolving
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