Sinopharm's presentation on their Beijing vaccine to WHO's expert committee is now online: cdn.who.int/media/docs/def… 1/n HT @AlejandrodeBar1
...Includes this overview of preclinical toxicity studies. (Note, they've also published this study on some preclinical work tandfonline.com/doi/full/10.10…) ...2/n
...The phase 3, #4Humanity trial in the Middle East - here are the blood collections taken across all the countries. (No answer here to the question of whether there were regular tests for Covid-19 in the UAE part of the trial)...3/n
...Breakdown of participants by country: about 11,000 people from outside the UAE...4/n
...Breakdown of participants just in the Beijing vaccine & placebo arms. <14% non-Asian. (Would have been helpful to see this defined, but we haven't seen a protocol for this trial yet)...5/n
...2 doses were 3 weeks apart, vaccine efficacy calculated from 14 days after the 2nd dose:
- Against Covid-19, 78.1% (CI 76-86) - *appears not to be only symptomatic Covid-19*
- 0 severe Covid-19 in vax group, 2 in placebo
...6/n
...I wish this was explained here or in WHO summary. Rate against asymptomatic infection only - doesn't say how that was detected:
- 50.4% (CI: -2 to 76) (11 in vax group, 22 in placebo)
Listed under subgroup analyses, implying the overall efficacy isn't only symptomatic ...7/n
...Solicited adverse events for the whole group. Placebo is blue: higher than vax for mild (grade 1) events. No difference for other levels of events. This is such a low rate rate of adverse reactions to Covid vaccine injections...8/n
...Incidence of adverse events displayed in 3 time periods (blue is placebo) ...9/n
... Serious adverse events (SAEs). In 2 people, they were vax-related, but events not described. (My explainer on the language of AEs: absolutelymaybe.plos.org/2021/02/21/a-r…) ...10/n
...Very few people aged 60+ in this trial. Here are neutralizing antibodies in a small subset of the under-60s vs most of the vaxed aged 60+ (172 out of 294).
So a larger proportion of older people would seem likely to have reduced overall vaccine efficacy ...11/n
...There's a post-marketing study for 9,800 people in Mozambique for Beijing vax, with co-administration (but it doesn't say what - flu vaccine?). If anyone knows more details of this study, please let me know!
They thanked the research participants at the end. #4Humanity 12/12
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