UK phase 3 trial of Novavax vax preprint. Later data than January press release with 62 cases of Covid-19. Now 106. Vaccine efficacy:
- Against original strain: 96.4% (74 to 99.5)
- Against B.1.1.7 ("UK") strain: 86.3% (71-94)
- Total 89.7% (80-95)
..1/n
medrxiv.org/content/10.110…
- Against original strain: 96.4% (74 to 99.5)
- Against B.1.1.7 ("UK") strain: 86.3% (71-94)
- Total 89.7% (80-95)
..1/n
medrxiv.org/content/10.110…
...Symptomatic Covid-19 for primary endpoint (from 7 days after 2nd dose in people with no previous infection): target number for final analysis was 100.
From 14,039 people:
- 10 cases in vax vs 96 placebo;
- 0 severe illness in vax vs 5 in placebo;
- 0 deaths
...2/n
From 14,039 people:
- 10 cases in vax vs 96 placebo;
- 0 severe illness in vax vs 5 in placebo;
- 0 deaths
...2/n
...The people in the trial were:
- 48% female
- 94.5% White
- 2.9% Asian
- 0.4% Black or African American
- 45% had a co-morbidity
...3/n
- 48% female
- 94.5% White
- 2.9% Asian
- 0.4% Black or African American
- 45% had a co-morbidity
...3/n
...Solicited adverse events (AEs) subgroup is 2,310 people. The most common systemic AEs:
- headache, muscle ache & fatigue: 40.0 to 40.3% after 2nd dose
For context, on highest for some others:
- Moderna 65%
- AZ 62%
- BNT-Pfizer 56%
- J&J 38%
- inactivated vax 2-4%
...4/n
- headache, muscle ache & fatigue: 40.0 to 40.3% after 2nd dose
For context, on highest for some others:
- Moderna 65%
- AZ 62%
- BNT-Pfizer 56%
- J&J 38%
- inactivated vax 2-4%
...4/n
...AE severity harder to gauge: there isn't a table of the data & it's not broken down by age (though there's some data in the text). At first look, seems to be in the same ball park as BNT-Pfizer - that is, less severe than Moderna & AZ (as well as less common than all 3)
...5/n
...5/n
...Just realized I didn't include in previous tweet on severe outcomes: 0 hospitalizations for Covid-19 in the vaxed group. (Doesn't say how many in placebo)
Vaccine efficacy in 65+ was 88.9%* from 7 days, & 83.4% (74-90) from 14 days.
(* typo in CI so not included it)...6/n
Vaccine efficacy in 65+ was 88.9%* from 7 days, & 83.4% (74-90) from 14 days.
(* typo in CI so not included it)...6/n
... Variants for the 106 people with symptomatic Covid-19:
- Original: 29
- B.1.1.7: 66
- Unknown: 11
Note on limitations in how this was assessed...7/n
- Original: 29
- B.1.1.7: 66
- Unknown: 11
Note on limitations in how this was assessed...7/n
...There were 2 Covid-19 related deaths: 1 in the vaxed group before the efficacy analysis period (onset of symptoms 7 days after 1st dose, so that's before there could be vax-provided immunity) & 1 in the placebo group (presumably also outside the efficacy analysis period)...8/n
...Not much detail on the severe & serious adverse events. But rates weren't increased in the vax group. There were 3 grade 4 AEs*, 2 of which were fever. No anaphylaxis (severe allergic reaction).
* See my post for what that means absolutelymaybe.plos.org/2021/02/21/a-r… ...9/10
* See my post for what that means absolutelymaybe.plos.org/2021/02/21/a-r… ...9/10
...Statistical analysis plan provided - protocol already available, but supplementary info has both.
Very high efficacy (incl holding up in SA trial against that variant) & lower rate of adverse reactions. If this holds in the big US trial, it'll stay top of the class. 10/10
Very high efficacy (incl holding up in SA trial against that variant) & lower rate of adverse reactions. If this holds in the big US trial, it'll stay top of the class. 10/10
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