Thread by @MonicaGandhi9

Here is full Johnson & Johnson dataset provided to FDA. Remember, this is one-dose vaccine and is an adenovirus vector with DNA inside your body will use to code for the full spike protein + receptor binding domain. We had press release data now have more
fda.gov/media/146217/d…

ENSEMBLE- Phase 3 randomized, double-blind, placebo-controlled trial of a single
dose (5x10^10 vp) of Ad26.COV2.S in ~40K participants
for pro-protocol analysis. Results 14 & 28 days after the one-dose (28 days likely best indicator given immunogenicity data that shows Ab titers

keep on going up in phase I/II data). Let’s start with worse outcomes & move backwards. . Deaths: 7 COVID-19 related deaths in placebo group and none in vaccine group so 100% protection against death. 29 hospitalizations in placebo group from COVID-19 and 2 in vaccine group so

94% protective there. NO COVID-19-related deaths & cases needing medical treatment in those >60 with comorbidities who got vaccine. 66.1% efficacy against all cases (could be asymptomatic- will tell you later) across all 3 sites at 28 days. Here is definition of moderate

And here is definition of severe- 100% protective against hospitalization if you take analysis out to 28 days (16 in placebo group; 0 in vaccine group).

74 percent protective against asymptomatic infection (PCR confirmed) and we will do variants next: D614G in
the U.S. (96.4% of sequenced cases), B.1.351 in South Africa (94.5% of sequenced cases), and variant of the P.2 lineage in Brazil (69.4% of sequenced cases)

So, even with the high percentage of circulating virus during the study being variant (study 9/21/20-1/22/2021 for data), vaccine efficacy against severe/critical COVID-19 was comparably high across the three regions. Difference in efficacy was for mild disease across variants

The 2 deaths in vaccine group were secondary to respiratory infections not due to COVID-19 (pneumonia & lung abscess). So to sum it up
100% protection against death from COVID-19
100% protection against hospitalizations due to COVID-19
this is across variants

Let's elaborate more on "prevents 74% asymptomatic cases"-asymptomatic defined as never had symptoms but who either seroconverted to COVID (natural infection) or had +PCR without symptoms. Will get more data when day 71 serology is available for all- below is table so far (74.2%)