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Hilda Bastian, PhD Profile picture
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19 Feb, 5 tweets, 2 min read
This Oxford-AstraZeneca vaccine study from a preprint a couple of weeks ago is now published in the Lancet. At first look, there are some additions... 1/n thelancet.com/journals/lance…
...In the original thread, I'd had a question about hospital admissions, but ignore that if you re-read it: the wording is expanded a little in the paper, & it clears it up... 2/n
...The supplementary info includes listing of serious adverse events & unsolicited adverse events, but no data on solicited adverse events - all of that is new...3/n thelancet.com/cms/10.1016/S0…
...The limitations section now includes relevant differences in the group getting only 1 dose (the data were included in the preprint, but it wasn't highlighted in this way as the important limitation that it is)...4/5
...The data appear to be the same, but I didn't compare carefully. (There are presentation differences eg vaccine efficacy data now goes to a decimal point.)...5/5

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Hilda Bastian, PhD Profile picture
18 Feb
EMA (Euro drug regulator) assessment report for the Oxford-AstraZeneca vaccine is online. This one's 181 pages. Most of it's based on the original November data (as in the Lancet publication) but some includes is Ded 7 data (as in recent preprint): ema.europa.eu/en/medicines/h… ...1/n
...They had a major objection to the US manufacturing plant (it's also manufactured in the UK & Belgium - EMA is not assessing Covishield, the Indian version, at all). However, their concerns were resolved. Sounds like it was missing certification...2/n
...EMA wants additional data to validate quality of manufacture at all 3 sites is comparable. Since there's no assessment of Covishield here & WHO didn't do it, I assume this rests totally on the Indian regulator, which published no data (Indian trial still unpublished)...3/n
Read 21 tweets
Hilda Bastian, PhD Profile picture
16 Feb
TGA (Australian drug regulator) issued 2-year provisional approval for the Oxford-AstraZeneca vaccine, no age restrictions, with a cop-out on age - pushing the onus onto individual decisions. 4 to 12 week interval tga.gov.au/media-release/… ...1/n
...The Public Assessment Report released with the decision (49 pages) tga.gov.au/auspar/auspar-… It's for the AstraZeneca version: when CSL (local producer) is ready to supply, that won't need new clinical data... 2/n
...Reproductive safety study in mice is still underway - not recommended for pregnant women before then. Under clinical data, raised issue of follow-up injections possibly decreasing immunity... 3/n Image
Read 9 tweets
Hilda Bastian, PhD Profile picture
13 Feb
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
Read 9 tweets
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
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
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

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