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…

#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…

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 🧵 @PLOS absolutelymaybe.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...

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 ....

https://twitter.com/Tammy_Hoffmann/status/1498088651053416448

...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…

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"...

First phase 3 efficacy results for the Clover vax are out in a detailed press release. cloverbiopharma.com/news/83.html

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

🧵 recent studies on Covid vax in people who are immunocompromised: none are randomized trials. But first, 3 new trials are kicking off … 1/21 ….Trial registered in Israel for 450 people with kidney transplants who didn’t have a strong response to 2 BNT-Pfizer doses: a 3rd dose, with or without reducing immunosuppressive treatment clinicaltrials.gov/ct2/show/NCT04… #IC …2/21

6-month followup for major BNT-Pfizer vax trial. While still blinded, overall vaccine efficacy was:

- against symptomatic Covid-19: 91.1% (89-93)
- against severe Covid-19: 96.7% VE (80-99.9)

...1/n
medrxiv.org/content/10.110… (preprint) ...Vaccine efficacy peaked before 2 months after dose 2, & then waned somewhat over time: from 4-6 months it was 83.7% (75-90). They estimate it declines by about 6% every 2 months... 2/n

Results from whole-of-town Covid vax study of Schwaz, Austria: Alpha & Beta outbreak. BNT-Pfizer vax offered to all aged 16+ at once. Under 80% of the adult population took it up (16-17 yr olds not reported) ...1/n researchsquare.com/article/rs-741… (Preprint) HT @florian_krammer ...They combined results from 5 similar districts as a "synthetic control group" & compared them to Schwaz. (They don't seem to report the population numbers in this preprint.) Rates of "cases" were similar in Schwaz vs others before the mass vax...2/n

#tbt One of the greatest breakthroughs in immunology – working out how where antibodies are produced – was made by a PhD student in her 1948 dissertation: Astrid Fagraeus (1913-1997). She would play a major role in developing the vaccine that eradicated polio from Sweden ...1/9 ...She was born in Stockholm. Her father was a Consul-General en.wikipedia.org/wiki/Astrid_Fa… I think he's the same Isidor Fagraeus described as a banker who bought this estate in 1918: if so, she grew up in this glorious place that's now a destination hotel
skytteholm.se/en/the-history… 2/9

Phase 3 for Covaxin: 130 events (symptomatic Covid-19) in 16,973 people at least 2 weeks since second dose (either vax or placebo)
- Vaccine efficacy against symptomatic disease 77.8% (65-86)
- Severe Covid 93.4% (57-99) ..1/n
medrxiv.org/content/10.110… (Preprint) HT @swapneilparikh ...11% were older than 60; 67% men. Race/ethnicity not reported.
A lot of people excluded from the main analyses because they had signs of previous SARS-CoV-2 infection: 30%. (That's the same method as other vaccines - just a lot more people affected than early trials.)
...2/n

The big US/Mexico trial for Novavax is in - & yep, Novavax stays top of the class (if adverse events are as low as they were in UK trial).
Up against largely Alpha variant of concern, vaccine efficacy was 90.4% (83-95) ... 1/n ir.novavax.com/news-releases/… HT @carlzimmer ...Trial of 29,960 people
- 14 vaxed people got mild Covid-19 vs 63 in placebo;
- Moderate/severe: 0 vaxed, 14 in placebo;
- Efficacy against variants of concern or interest was 93.2% (84-97)
- High risk people (>65 or co-morbidities): 91.0% (84-95)...2/n

Catch-up 🧵 on reports of Covid vax & immunocompromised people. Overall, starting to look like a head-to-head trial of Moderna & BNT-Pfizer vax for some groups would be worthwhile ... #IC ...78 people on hemodialysis in Spain getting Moderna vax: immune response grew slowly, but was high 6 weeks after being fully vaxed... academic.oup.com/ndt/advance-ar… #IC

#tbt "My work is what will survive", she said. She co-authored this 1945 book, with chromosomes of over 10,000 plants. Magnolias that botanist & cytogeneticist Janaki Ammal planted at RHS around then survive too, including this one named after her ...1/9 natsca.blog/2019/04/26/my-… ...E.K. Janaki Ammal (1897-1984) was 10th of 19 children in a mixed-race family in Kerala, India, with caste adding to the discrimination in her life. She chose a life in science over a planned marriage & her achievements are the stuff of legends thebetterindia.com/75174/janaki-a… ...2/9

A government report on Covid vaccination is out from Uruguay gub.uy/ministerio-sal… HT @sgdambrauskas
First, some perspective on the wave Uruguay is struggling with: here's a chart Our World in Data, per million population...1/n ...45.8% of the population had at least one dose of Covid vax as of May 25, mostly Sinovac's CoronaVac & some BNT-Pfizer; 28% of the population has had 2 doses. (The population of Uruguay is about 3.5million)...2/n

#tbt This is the graduating class of 1915, chemistry division, Tohoku Imperial University. There, at the end of the 2nd row, is the first woman to achieve a bachelor of science in Japan. Her name was 黒田チカ, Chika Kuroda (1884-1968) & she was the daughter of a samurai...1/5 ...Kuroda was an organic chemist & studied natural pigments. As an undergraduate, she studied a purple one, Lithospermum erythrorhizon. When she presented her work on it to the Chemical Society of Japan, she was the first woman to ever do that, too ...2/5
en.wikipedia.org/wiki/Chika_Kur…

The #4Humanity phase 3 trial of Sinopharm's Beijing & Wuhan vaccines published in JAMA by @NawalAlKaabi &co jamanetwork.com/journals/jama/… HT @swiftshoes

WIV04 = Wuhan: efficacy 14 days+ after dose 2, 72.8% (58-82)
HB02 = Beijing: 78.1% (65-86)
Control group was vax adjuvant ...1/n ...Wuhan vax 12,743; Beijing 12,726; control 12,737. Just under 16% were women, <2% were aged 60 & over

Primary efficacy outcome (in tweet 1) was symptomatic Covid-19: 26 in Wuhan group, 21 in Beijing, 95 in control.

Severe Covid-19: 0 in vaxed groups, 2 in control group ...2/n

Public Health England estimate of vax effectiveness against B.1.617.2 variant: they're not reporting vaxes separately yet. Combined data: 1 dose doesn't reach minimum effectiveness level; 2 doses it's reduced, but still high...1/2 HT @statsepi @kallmemeg assets.publishing.service.gov.uk/government/upl… ...They have moderate degree of certainty in conclusion from data on 1 dose, low for 2-dose. Based on the neutralization activity they see in lab tests, "expected to remain effective against severe disease". They don't say when data will be released. 2/2 assets.publishing.service.gov.uk/government/upl…

UK phase 3 trial of Novavax vax preprint. Later data than January press release with 62 cases of Covid-19. Now 106. Vaccine efficacy:

- Against original strain: 96.4% (74 to 99.5)
- Against B.1.1.7 ("UK") strain: 86.3% (71-94)
- Total 89.7% (80-95)

..1/n
medrxiv.org/content/10.110… ...Symptomatic Covid-19 for primary endpoint (from 7 days after 2nd dose in people with no previous infection): target number for final analysis was 100.

From 14,039 people:
- 10 cases in vax vs 96 placebo;
- 0 severe illness in vax vs 5 in placebo;
- 0 deaths

...2/n

Preprint of results for Sinovac CoronaVac phase 1/2 trial in 3-17 year-olds: 72 in phase 1, 480 in phase 2. They tested half & full doses, & immune responses were higher than they are in adults, with a very low rate of adverse reactions ...1/n papers.ssrn.com/sol3/papers.cf… ...Firstly, it's clear why they have gone on to do another large study in under-18s (clinicaltrials.gov/ct2/show/NCT04…). The children were all Han ethnicity & they want to test in other parts of the country to get more diversity...2/n

Preliminary results of CombiVacS, the Spanish phase 2 trial of BNT-Pfizer vax at least 8 weeks after AZ announced: major boost in neutralizing antibodies - more than in other studies of 2 doses of AZ - without a higher rate of adverse reactions ...1/n english.elpais.com/society/2021-0… ...The results from @SaludISCIII are here isciii.es/Noticias/Notic…

Trial register record is here: clinicaltrials.gov/ct2/show/NCT04…

They're reporting immediately after Data Monitoring Board so people can get their 2nd shots ASAP - control group will now be getting a BNT-Pfizer shot...2/n