Preprint of the South African phase 1b/2 trial for the Oxford/AstraZeneca vaccine is online. Primary efficacy analysis is for 2,026 people who weren't infected with HIV (there was also a very small arm of people who were HIV+) medrxiv.org/content/10.110… ...1/n
...This shows you how the new variant spread in the 2 provinces the trial was conducted in...2/n
..As we already knew, the overall efficacy was 22%, but only 10% against the new variant, with a wide range of uncertainty: but enough for the trial's protocol for excluding efficacy. There were no severe illnesses in the vaccinated or placebo groups: a young, low risk group..3/n
...Out of the events (people with symptomatic Covid-19), there were:
Vaccinated group: 15 mild, 4 moderate, 0 severe
Placebo group: 17 mild, 6 moderate, 0 severe ....4/n
...They did an unplanned analysis of the time up to October 31 - before the variant arrived. Efficacy was 75.4% (CI: 8.9 to 95.5). (That's also an extreme amount of uncertainty)... 5/n
...Antibodies weren't able to protect people from mild disease; T-cells could however provide protection against severe illness. But they couldn't answer that in this trial. However, they include data from 17 people in the UK trial...6/n
...Sequencing data are included in a supplementary file. That data suggests that T-cells generated after vaccination are not as affected by the mutation in the variant. But clinical data are needed to show if this = protection against severe disease medrxiv.org/content/10.110… ..7/n
...The authors point to the efficacy of the J&J vaccine at preventing severe Covid-19 in South Africa since the arrival of the variant as another reason it's possible there's still some protection. Only a trial can test that now & that's complicated at this stage...8/n
...Because severe Covid-19 is fortunately so much less common than mild disease, you need a larger trial, with people at risk of severe disease, than for more common outcomes. Very tough situation. /9
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Unofficial unnamed AstraZeneca insider says they are doing the interim analysis for the US trial of the Oxford vaccine. AstraZeneca spokesperson says 4-6 weeks till data release. reuters.com/article/uk-hea… One is wrong? Or they'll release only when have FDA minimum follow-up?
..With results for AstraZeneca's large trial of the Oxford vaccine on the horizon ⬆️, some things I'm keeping in mind. It's a single, adequately powered, standardized, double-blind, fully placebo-controlled trial: the first for this vaccine. It's 2 doses, 4 weeks apart, so...2/8
...not designed to test the hypothesis that 8-week or 12-week interval increases efficacy. But as with other large vaccine trials, there'll be data relevant to onset of immunity to chew on. It's 2:1 randomization (twice as many in vax as placebo), final goal 150 events...3/8
Sinovac's CoronaVac's phase 3 trial results: some data from Turkey in press release. Brazilian trial, much as Brazil announced: 50.65% vaccine efficacy for all symptomatic disease, 83.7% for people requiring medical care - & no severe or fatal disease..1/n businesswire.com/news/home/2021…
...Some extra context on the trial in Turkey. Essentially same result we heard before: 91.3% efficacy based on 29 people with symptomatic Covid-19 among 1,322 people. The confidence intervals on that when Turkey announced it: 71-97%
...So no additional efficacy results; possible difference in healthcare workers. All 4 trials used vaccine from the same lot, which is good to know. No data from the other 2 trials (Indonesia & Chile), though. Records on this vaccine: zotero.org/groups/2528572…
New preprint on the Oxford/AstraZeneca vaccine & B.1.1.7 ("UK" variant). Includes data on the people diagnosed with Covid-19 up to Jan 14 (so a month of extra data than their recent preprint on single dose)... 1/n papers.ssrn.com/sol3/papers.cf… (HT @joelving) ...1/n
...The vaccine reduced efficacy (more on that later). They were able to sequence the virus for 256 out of the 499 people sick with Covid-19...2/n
...The analysis is based on the UK phase 2/3 trial, where participants had regular swabs. So it includes the people they detected who had asymptomatic & symptomatic Covid-19....3/n
New data for the Oxford/AstraZeneca vaccine, with extra month's worth of data, & combining 4 trials from phase 1 to 3, focusing on 1st dose: Indian phase 2/3 trial still not included. 332 events... 1/n papers.ssrn.com/sol3/papers.cf… (Preprint) (TY to the people who alerted me to it)
...Includes 2 phase 1/2 trials in UK & South Africa (2 in Japan & Kenya not included); phase 2/3 trial in the UK (phase 2/3 in India not included); & phase 3 in Brazil. A mixture of trials with & without primary efficacy endpoints. (US phase 3 trial still not this far)...2/n
...New analysis includes a range of non-standardized doses, including accidental low-dose group, with comparison mostly a meningococcal vaccine (Brazil, placebo 2nd shot). For the trials which were originally single shot trials, people were offered the 2nd: not all agreed...3/n
Phase 3 trial for Sputnik V results landed!
To keep in mind: randomized 3 to 1 (not half in vax group, half placebo). It's a pair of vaccines, 1 shot of each, not same vax twice. Both are adenovirus vector vaccines - same category as Oxford & J&J... 1/n thelancet.com/journals/lance…
...We never saw a protocol for this one previously - and there isn't one released with this paper either... 2/n
...They measured their primary outcome from 21 days after the *first* vaccine (the shots are 21 days apart).
These people are at comparatively low risk of poor Covid-19 outcomes: 99% white; about 90% aged 60 or under; <1% at high risk of infection...3/n
...34% were over 60 (14,672 people). Diverse, from South Africa & the Americas. 41% had co-morbidities putting them at risk of severe Covid-19. Protection was consistent across age, race, & part of the world - even though 95% in SA were infected with the new "SA" variant...2/n
...First trial powered to answer the severe Covid-19 question: efficacy was 85% at 28 days after the injection (no event breakdown or confidence intervals). For moderate to severe, efficacy was 66%, varying a bit in the 3 regions (from 57% in SA to 72% in the US...3/n