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Hilda Bastian, PhD Profile picture
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6 Feb, 4 tweets, 2 min read
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% ...2/n
...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…
...PS: You can jump to the CoronaVac section in my post to see more details on the Brazilian trial (which had some people over 60 - the Turkish trial is for under 60s) absolutelymaybe.plos.org/2021/01/31/var…

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More from @hildabast

Hilda Bastian, PhD Profile picture
6 Feb
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
Read 19 tweets
Hilda Bastian, PhD Profile picture
5 Feb
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
Read 14 tweets
Hilda Bastian, PhD Profile picture
2 Feb
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
Read 21 tweets
Hilda Bastian, PhD Profile picture
2 Feb
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
Read 19 tweets
Hilda Bastian, PhD Profile picture
29 Jan
J&J ENSEMBLE data is here - what. a. day.

It works with a single, simple to distribute, shot, which is huge. And it's complicated.

Largest set of events yet: 468 people with symptomatic Covid-19 in 43,783

...1/n jnj.com/johnson-johnso…
...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
Read 8 tweets
Hilda Bastian, PhD Profile picture
28 Jan
Interim readout from Novavax phase 3 from the 15k UK & 4.4k phase 2b from South Africa. High efficacy in the UK: 89.3% (95% CI: 75.2 – 95.4) - lowered a bit by the new variant...1/n ir.novavax.com/news-releases/… Image
...SA results heavily affected by new variant. Overall efficacy was 60% efficacy (95% CI: 19.9 – 80.1) for the bulk of people who were HIV- : very wide confidence intervals, because it's a small trial. With small HIV+ group included, (efficacy of 49.4%; 95% CI: 6.1 – 72.8) ...2/n
...Critically, the primary efficacy result, as for the other vaccines, is for people who hadn't had a previous SARS-CoV-2 infection. But 1/3 did. No data released for them, but previous infection may not protect against the new "SA" variant ...3/n Image
Read 8 tweets

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