ca 600,000 vaccinated with BNT-Pfizer vaccine in Israel, matched on demographic/clinical characteristics of 600,000 unvaccinated (median age 45) showed results similar to the phase 3 trial... 1/n…
...Similar pattern, for infection, symptomatic Covid-19, hospitalization, severe disease, death: 10,561 people infected, 57% of them developed symptoms; 369 in hospital, 229 severe Covid-19, 41 deaths...2/n
...7 days after 2nd dose: 92% efficacy against infection (CI: 88 to 95) - that's a strong result. Hospitalization: 87% (CI: 55 to 100) - wide confidence intervals, so not so certain. Remember, it's a group on the young side...3/n
...The group is on the young side, because so many older people were vaccinated so fast, it was harder to get a matched group of unvaccinated older people in that time...4/n
...Vaccine efficacy was similarly high in older people, including over 70. The study doesn't analyze for variants, but at that time, up to 80% of infections in Israel were B.1.1.7 ("UK" variant), & B.1.351 "SA" variant was rare. /5

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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
...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
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
22 Feb
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
Read 18 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

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