Share this page!

Hilda Bastian, PhD Profile picture
Twitter logo
10 Mar, 4 tweets, 2 min read
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…
...These are the 2 vaxes in the big #4Humanity trial led by UAE. As far as I can see, the Peru trial was the only other for the Wuhan vax. (There are some more trials for Beijing). If only all regulators were empowered to release results whether the company wanted to or not! 4/4

• • •

Missing some Tweet in this thread? You can try to force a refresh
　

Keep Current with Hilda Bastian, PhD

Hilda Bastian, PhD Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @hildabast

Hilda Bastian, PhD Profile picture
11 Mar
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
Read 5 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

Did Thread Reader help you today?

Support us! We are indie developers!

This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal Become our Patreon

Thank you for your support!

Follow Us on Twitter!

Like this author's thread?

Get emails when @hildabast has new unrolls!

Check out other threads from @hildabast!

Read all threads by @hildabast