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Hilda Bastian, PhD Profile picture
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11 Mar, 5 tweets, 2 min read
The Danish Health Authority has suspended use of the Oxford-AstraZeneca Covid vaccine for 14 days as a precaution while an investigation into serious adverse events proceeds...1/n sst.dk/da/Nyheder/202… HT @iamPWK
...There is no confirmation that the vaccine caused any of the serious adverse events (SAEs) under investigation: this is a precaution, while the investigation proceeds. The SAEs are related to blood clots in Austria & Denmark ...2/n
...There were 2 thrombosis-related (blood clot) SAEs in Austria & the first investigation was whether it was related to a specific batch of vaccine. The EMA (Euro drug regulator) determined that there wasn't a problem with the batch...3/n
...There was a thrombosis-related SAE in Denmark: again, not determined to have been caused by vaccine. 2 out of these 3 people died; that's why they are going to major lengths to investigate. It could be coincidence but they need to be confident about this so we can be too...4/5
..Next? Multiple levels of investigation. The cases will be investigated. Regulators search monitoring systems for any further reports of thromboses. More effort will go into biological evidence to consider if there's a basis for concern. Now we wait & keep it in perspective 5/5

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More from @hildabast

Hilda Bastian, PhD Profile picture
10 Mar
Data & Safety Monitoring Board for phase 3 trial of Sinopharm's vaccines in Peru - about 12,000 people, 2 vaccines vs placebo - has recommended discontinuation of the Wuhan vaccine arm for inadequate efficacy (*not* the Beijing vax in use globally) ...1/n cayetano.edu.pe/cayetano/es/no…
...The university running the trial have sought the permission of the drug regulator to unblind participants & offer the volunteers in the Wuhan & placebo arms vaccination with the Beijing vaccine which did meet efficacy criteria (results aren't ready for release though)...2/n
...Sinopharm recently issued a press release saying the Wuhan vaccine efficacy rate was 75%. They applied to NMPA (China's drug regulator for authorization). NMPA authorized it on Feb 27 ...3/4 english.nmpa.gov.cn/2021-02/27/c_5…
Read 4 tweets
Hilda Bastian, PhD Profile picture
3 Mar
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
Read 8 tweets
Hilda Bastian, PhD Profile picture
1 Mar
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
Read 7 tweets
Hilda Bastian, PhD Profile picture
25 Feb
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
Read 5 tweets
Hilda Bastian, PhD Profile picture
24 Feb
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
Read 21 tweets
Hilda Bastian, PhD Profile picture
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: fda.gov/advisory-commi…

Trial protocol: jnj.com/coronavirus/en…

Press release with trial efficacy readout: jnj.com/johnson-johnso…

My thread on it:

Records on this vaccine: zotero.org/groups/2528572… ...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

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