...Includes this overview of preclinical toxicity studies. (Note, they've also published this study on some preclinical work tandfonline.com/doi/full/10.10…) ...2/n
...The phase 3, #4Humanity trial in the Middle East - here are the blood collections taken across all the countries. (No answer here to the question of whether there were regular tests for Covid-19 in the UAE part of the trial)...3/n
...Breakdown of participants by country: about 11,000 people from outside the UAE...4/n
...Breakdown of participants just in the Beijing vaccine & placebo arms. <14% non-Asian. (Would have been helpful to see this defined, but we haven't seen a protocol for this trial yet)...5/n
...2 doses were 3 weeks apart, vaccine efficacy calculated from 14 days after the 2nd dose:
- Against Covid-19, 78.1% (CI 76-86) - *appears not to be only symptomatic Covid-19*
- 0 severe Covid-19 in vax group, 2 in placebo
...6/n
...I wish this was explained here or in WHO summary. Rate against asymptomatic infection only - doesn't say how that was detected:
- 50.4% (CI: -2 to 76) (11 in vax group, 22 in placebo)
Listed under subgroup analyses, implying the overall efficacy isn't only symptomatic ...7/n
...Solicited adverse events for the whole group. Placebo is blue: higher than vax for mild (grade 1) events. No difference for other levels of events. This is such a low rate rate of adverse reactions to Covid vaccine injections...8/n
...Incidence of adverse events displayed in 3 time periods (blue is placebo) ...9/n
... Serious adverse events (SAEs). In 2 people, they were vax-related, but events not described. (My explainer on the language of AEs: absolutelymaybe.plos.org/2021/02/21/a-r…) ...10/n
...Very few people aged 60+ in this trial. Here are neutralizing antibodies in a small subset of the under-60s vs most of the vaxed aged 60+ (172 out of 294).
So a larger proportion of older people would seem likely to have reduced overall vaccine efficacy ...11/n
...There's a post-marketing study for 9,800 people in Mozambique for Beijing vax, with co-administration (but it doesn't say what - flu vaccine?). If anyone knows more details of this study, please let me know!
They thanked the research participants at the end. #4Humanity 12/12
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FDA report on the Novavax vaccine questions whether there's a causal relationship for myocarditis/pericarditis after the vax. This 🧵digs into their report, the Novavax response & submission, & rollout data... (1/8)
...FDA report on Friday lists 6 cases in vaxed arms of 2 trials, 4 of which don't have a specific possible alternative cause identified. This was versus 1 in placebo (not injection-related). The 2 trials had ca 27,000 vaxed participants... fda.gov/media/158912/d…
...FDA report expressed concern because a pre-marketing database of ~40,000 had more potential cases, & this hadn't been a pre-marketing safety signal for mRNA vaccines: so to them it raised Q if it could be higher for this vax than for mRNA vaxes...
#tbt This is Toshiko Yuasa, the first woman physicist from Japan. It's 1940 & with her science prospects at home blocked by gender prejudice, she'd managed to get into wartime Paris to do physics research... en.wikipedia.org/wiki/Toshiko_Y…
...The drawcard in Paris was Marie Curie's daughter, Irène Joliot-Curie & her husband Frédéric. Yuasa was inspired by their papers on artificial radioactivity.
Here's Toshiko & Irène at the Joliot-Curie home in 1941... en.wikipedia.org/wiki/Ir%C3%A8n…
...Yuasa was born in downtown Tokyo in 1909, the next-to-youngest of 7 children. Her mother came from a long line of poets, in the family of a renowned 19th century scholar, Tachibana Moribe. Her father was an engineer & inventor who worked at the patent office...
When it hit me that I knew nothing about early women scientists in Ukraine, I went down a mind-blowing rabbit hole...
So hard to pick, but I whittled down to 15 amazing stories of women born before WWII.
Today, part 1, with the first 5 women 🧵 @PLOSabsolutelymaybe.plos.org/2022/04/27/ear…
...This is Maria V. Pavlova (1854-1938), at her desk in the 1920s with fossils. She corrected an error in assumptions about the ancestry of horses...
...Sofia Okunevska-Morachevska (1865-1926) was an activist doctor - the 1st medically qualified woman in the Austro-Hungarian empire, not just Ukraine....
Such terribly sad news: the loss of Chris Del Mar, a giant of the Australian – and global – evidence community.
💔 for Tammy & family.
You'll hear a lot about this wonderful, lovable person & his amazing life ....
...Here's a quick overview from late last year, when Chris was awarded the Order of Australia - one of my faves because of the lovely family photo.... www1.racgp.org.au/newsgp/profess…
...I want to add to the remembrances & accolades for Chris, memories of a specific stream of his life - patient empowerment. From back in the early 2000s when we used to use this photo. He was the Chair of the Board of the consumer health information NGO I headed back then...
1st Covid human challenge trial results shows it is feasible: 34 people were inoculated with a very low dose. It was enough to infect 18 people (53%) & 89% of them developed symptoms ...🧵 researchsquare.com/article/rs-112… HT @HelenBranswell
..Viral shedding quantifiable within 40 hours. They concluded up to 44% of infections would happen before virus can be detected. Results support 10-day isolation periods & professionally-administered LFA/RAT was "highly reliable in predicting the disappearance of viable virus"...
...The people were 18-29 years old, & stayed in individual negative pressure quarantine rooms. No safety signals in these first 28 days of follow-up. (They'll follow them for a year)...
Great relief: it's a critical vax for the COVAX supply. Protein subunit vax, with a Dynavax adjuvant & alum. Records on it: zotero.org/groups/2528572… ...1/n HT @lutl88
...The trial has 30,128 participants in Philippines, Brazil, Colombia, South Africa, Belgium. All infections sequenced were variants. Because of vax programs in these countries, not many older people...2/n
...For people without previous SARS-CoV-2 infection, 207 tested positive & 146 of these sequenced so far. 73% were Delta (most of them), Mu, & Gamma...3/n