Public Health England released leaked study - it's a copy of a manuscript submitted to a preprint server. It's not a study of who was vaccinated, but of vaccination status of people seeking Covid tests for symptoms ...1/n khub.net/documents/1359… HT @michael_jshaw@TheGazmanRants
...This study is a test negative case control study - it's a study design that's been used in a variety of vaccines. (Here's an article about this type of controlled study: journals.lww.com/epidem/Abstrac…)...2/n
...It's data from tests for the general community (called Pillar 2: doesn't include eg hospital testing). Data was linked to the National Immunisation Register, on Feb 22. Vaccination began in the UK on Dec 8 (with BNT-Pfizer), followed soon by Oxford-AstraZeneca vaccine...3/n
...There were 44,590 people aged 70 or over who tested positive for Covid-19; 112,340 who tested negative. Vaccination program started in people 80+ who weren't living in care homes, so they adjusted analyses for age & where people lived ...4/n
...Here are their main conclusions: efficacy for both vaccines was similar against symptomatic disease after a single dose, but there was less data on Oxford-AstraZeneca because it was introduced later: <250 people 28 days+; about 1,000 people 28 days+ for BNT-Pfizer ...5/n
...One effect of the shorter timeframe for the Oxford-AstraZeneca vaccine results is that the growth of immunity from this vaccine hadn't plateaued. But they conclude that their results correspond to the higher efficacy rate (>75%) with longer dose interval in the trials ...6/n
...Still too early to know what results will be when people get their second doses at longer interval for both vaccines. There was already a reduction in risk of hospitalization & death for people aged 80+ vaccinate with BNT-Pfizer within 21 days .../7
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Preprint of results from the Novavax phase 2 trial in South Africa with efficacy outcomes, with 4,387 participants. Sequencing done for most of the people with Covid-19: 93% were infected with B.1.351 ("SA" variant). ...1/n medrxiv.org/content/10.110…
...Small trial, so a lot of uncertainty in efficacy results.
Vaccine efficacy rates:
Overall (not previously infected with SARS-CoV-2): 49.4% (CI 6-73)
HIV- : 60.1% (CI 20-80)*
Against B.1.351 variant: 51.0% (CI 0.6-76)
* 6% of people in the trial living with HIV
...2/n
...About 30% of people tested positive for previous SARS-CoV-2 infection, & their risk of getting sick with Covid-19 was the similar to people who'd never been infected before. Placebo group: 5.3% vs 5.2%. Previous protection didn't protect against the variant ...3/n
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 nejm.org/doi/full/10.10…
...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
Away we go. J&J ENSEMBLE trial evaluation has landed - 8am again - thanks, FDA! ....1/n fda.gov/advisory-commi…
...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
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
...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
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 hps.scot.nhs.uk/a-to-z-of-topi… 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. 🤞 bbc.com/news/health-56… 2/2
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…