The #4Humanity phase 3 trial of Sinopharm's Beijing & Wuhan vaccines published in JAMA by @NawalAlKaabi &co jamanetwork.com/journals/jama/… HT @swiftshoes
WIV04 = Wuhan: efficacy 14 days+ after dose 2, 72.8% (58-82)
HB02 = Beijing: 78.1% (65-86)
Control group was vax adjuvant ...1/n
WIV04 = Wuhan: efficacy 14 days+ after dose 2, 72.8% (58-82)
HB02 = Beijing: 78.1% (65-86)
Control group was vax adjuvant ...1/n
...Wuhan vax 12,743; Beijing 12,726; control 12,737. Just under 16% were women, <2% were aged 60 & over
Primary efficacy outcome (in tweet 1) was symptomatic Covid-19: 26 in Wuhan group, 21 in Beijing, 95 in control.
Severe Covid-19: 0 in vaxed groups, 2 in control group ...2/n
Primary efficacy outcome (in tweet 1) was symptomatic Covid-19: 26 in Wuhan group, 21 in Beijing, 95 in control.
Severe Covid-19: 0 in vaxed groups, 2 in control group ...2/n
...The trial protocol and statistical analysis plan are included as supplements
Protocol: cdn.jamanetwork.com/ama/content_pu…
SAP: https://t.co/O67m8Nf7Tn
...3/n
Protocol: cdn.jamanetwork.com/ama/content_pu…
SAP: https://t.co/O67m8Nf7Tn
...3/n
...They identified cases of Covid-19 in 3 ways:
- Phone call to participants every week
- Notifications by the participating hospitals
- Linkage to the local medical systems
...4/n
- Phone call to participants every week
- Notifications by the participating hospitals
- Linkage to the local medical systems
...4/n
...This enabled posthoc analysis of vax efficacy against symptomatic & asymptomatic Covid-19, 14 days after dose 2:
- Wuhan: 64.0% (49-75) (42 cases)
- Beijing: 73.5% (61-82) (31)
116 symptomatic & asymptomatic people in the control group.
(44 tested + before 14 days) ...5/n
- Wuhan: 64.0% (49-75) (42 cases)
- Beijing: 73.5% (61-82) (31)
116 symptomatic & asymptomatic people in the control group.
(44 tested + before 14 days) ...5/n
... Here's what happened from after the first dose. Efficacy against symptomatic Covid-19:
Wuhan: 50.3% (34-63)
Beijing: 65.5% (52-75)...6/n
Wuhan: 50.3% (34-63)
Beijing: 65.5% (52-75)...6/n
...The trial took so long to get results because the coronavirus outbreak was so much lower in the countries in the Middle East where this trial was done. They calculated background rates for theirs & several other trials...7/n
... This analysis doesn't include the people who participated in the trial in Egypt & Jordan, because the data weren't yet available. They will be included in the final analysis from the trial...8/n
...They didn't test for variants, but none of the variants of concern were common in the Middle East at the time...9/n
...2 serious adverse events were considered possibly related to vaccine, both Beijing. One was severe vomiting, the other was possible demyelinating myelitis - the person was diagnosed with a rare genetic disorder...10/n
... Adverse reactions were similar in the vaccine & control groups (but there was no placebo group). Data were collected for all participants. The most common systemic adverse event reported was headache (13%)...11/n
...Overall, adverse reactions were low. Just over a third of people reported something mild (grade 1), usually pain at the injection site. Moderate (grade 2) was around 10% & severe (grade 3) <1% (You can read about what that means in my explainer: absolutelymaybe.plos.org/2021/02/21/a-r…)...12/n
...Limitations in who was included, especially age & gender. No data on co-morbidity: described as healthy group. A third were South Asian, 10% Chinese. Both vaxes worked well in these medium-sized groups at lower risk for a bad Covid outcome. 13/13
• • •
Missing some Tweet in this thread? You can try to
force a refresh
