Report from Scotland with great news on Covid vaccination reducing hospitalization rates. Not enough data released to be sure about much beyond that though, & number of vaccinated people hospitalized appears to be too small (happily!) to draw much beyond that though...1/2
..Some details about the study… BBC says 58 people in hospital who were vaccinated a month before: % by vaccine & for over 80s, but that number seems too small to break it down it by vaccine & age. Overall, ca 90% lower. 🤞… 2/2
...Ah ... preprint tweeted by @jaclark73 - thanks!… Just hunting out the numbers now... 3/n
..And Public Health England BNT-Pfizer data out too (but I'll start with Scotland)...4/n
...Scotland: people 80 & over were 1st priority: just over 200,000 people aged 80+ had 1 shot (few had 2). Because BNT-Pfizer was introduced much sooner, only a small proportion of people vaccinated 28 days or longer had Oxford-AstraZeneca...5/n
..Couldn't see numbers for each vaccine, but total "person years" vaccinated for all age groups 28 days+ are 9,463 for BNT-Pfizer (with 56 people hospitalized), 573 for Oxford-AstraZeneca (with 2 people hospitalized). Here's the sampling of unvaccinated people for comparison..6/n
...Although the rates of vaccine efficacy for 28 days+ are mostly for BNT-Pfizer vaccine, this figure shows that most people over 70 are getting the Oxford-AstraZeneca vaccine ...7/n
...Media reports are for the vaccine efficacy rates at their highest points 28 days & later: all time periods from 28 days aren't reported as a single group. At that peak for 80+yr-olds, it was 81% (CI: 65-90): there were 27 events (hospitalizations) (stayed around 80%)...8/n
...Now to the English report: it's only for BNT-Pfizer vaccine, which makes sense as numbers for Oxford-AstraZeneca are too small for after a month. Top line findings: note not representative for people over 80 as no care home residents… ...9/n
...Limitations include not being able to be sure that people in the comparison group didn't have some immunity from being infected etc...10/n
...Considering biases in the data, they conclude 3 weeks after a single dose of BNT-Pfizer vaccine, there's more than 50% reduction in symptomatic Covid-19, & for older people when ill, they're half as likely to be hospitalized or die - but that's only 2 weeks after vax ...11/n
...The decline in hospitalizations & deaths in older people is faster in this second lockdown than the first, so they conclude "may therefore be attributable to the high
vaccination coverage achieved in this age group" ...12/n
..Previous pic was over 70s. This is 80+. They report reductions overall are similar to after 1 dose of BNT-Pfizer in Israel & UK study in healthcare workers.

Overall from both these? Too soon for clear picture about Oxford-AstraZeneca, or delaying 2nd dose for either vax. /13
...And we're back to UK results. That UK study in healthcare workers mentioned ⬆️: that preprint is out too ...14/n… (HT @rajeev_the_king)
...This one's called the SIREN study & it's a prospective study BNT-Pfizer vaccine in healthcare workers in England. For those who were antibody-negative before vaccination, efficacy was 72% (CI: 58-86) 21 days after 1 dose, 86% (CI: 76-97) 21 days after 2nd dose...15/n
...The B.1.1.7 ("UK") variant was dominant during this study. The protocol for the study is here:… People who joined the study got tested for SARS-Cov-2 fortnightly, antibody testing once a month...16/n
...There were 23,324 healthcare workers in the group reported on: 84% female, 89% white. Data after 2 months. Only reporting on BNT-Pfizer vaccine ...17/n
...Vaccine efficacy is against infection, B.1.1.7 variant: efficacy 72% (CI: 58-86) 21 days after 1 dose, 86% (CI: 76-97) (middle set below: hazard ratio is 28% - other side of the 72% coin).

So protection against infection by BNT-Pfizer vaccine was high. 🥳 /18

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More from @hildabast

24 Feb
Away we go. J&J ENSEMBLE trial evaluation has landed - 8am again - thanks, FDA! ....1/n…
...First up, yes, outcome measure was reasonably close to what we're used to. Here it is based on the FDA-harmonized definition (including mild disease) - & keep in mind this is with South Africa &c included: vaccine efficacy 67% (CI: 56-75) (CI is a measure of uncertainty)...2/n Image
...This is what that looks like. Keeping in mind it's a single shot - and 28 days after it is about similar to the time of 7 days after BNT-Pfizer's second shot (as they're 3 weeks apart). (ENSEMBLE-2 is underway to see a 2nd shot on day 57) ...3/n Image
Read 21 tweets
24 Feb
It's another ENSEMBLE-watch day! The FDA meets on 26th to discuss the evaluation of the J&J single-shot vaccine - 3rd vaccine for FDA - & they aim to publish report 2 days ahead, which they achieved for the last 2. So 🤞 all will be revealed in a few hours ... 1/n
...This is where reports will be posted:…

Trial protocol:…

Press release with trial efficacy readout:…

My thread on it:

Records on this vaccine:… ...2/n
...Things I'll be watching out for. By far the biggest set of "events" (people with symptomatic Covid-19) of any trial. So it'll be the strongest data yet on questions past that top line efficacy - efficacy in severe disease, for example, which others had too few to answer ...3/n
Read 7 tweets
19 Feb
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…
...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…
Read 5 tweets
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):… ...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
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… ...1/n
...The Public Assessment Report released with the decision (49 pages)… 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
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+)… ...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

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