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 Image
..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 Image
...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

• • •

Missing some Tweet in this thread? You can try to force a refresh
 

Keep Current with Hilda Bastian, PhD

Hilda Bastian, PhD Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @hildabast

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
6 Feb
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…
Read 4 tweets
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
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
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
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

Did Thread Reader help you today?

Support us! We are indie developers!


This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal Become our Patreon

Thank you for your support!

Follow Us on Twitter!