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Hilda Bastian, PhD Profile picture
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20 Jan, 4 tweets, 2 min read
Sputnik V news: ANMAT, Argentina's drug regulator, has now extended authorization to people 60+ & released some data this time. Here's the listing of what they've received & analyzed (but it's not published) ... 1/n argentina.gob.ar/noticias/ampli…
...The new data on people 60+ they received: in 2,144 people, vaccine efficacy of 91.8% (95% CI 67.1% -98.3%). Almost all those people had antibodies by 28 days ...2/n
...ANMAT reports there's now data for 19,866 people who received both Sputnik V injections, with no serious adverse events (SAEs) judged to be vaccine-related. There were 47 SAEs in vax group vs 23 in placebo. Safety similar for older people in small safety study. 3/3
PS: Here's the trial registry report for the big Sputnik V trial. Randomized 3:1 (30k on vaccine, 10k placebo): clinicaltrials.gov/ct2/show/NCT04…

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More from @hildabast

Hilda Bastian, PhD Profile picture
22 Jan
For everyone else who's on ENSEMBLE-Watch - the big J&J trial for their Ad26.COV2.S vaccine - some background & context in case a press release lands soon. (On Wednesday, Stanford got the word to lock their data abc7news.com/johnson-and-va… so it is on!)...1/5
...It's a big trial - close to the size of the Pfizer trial for Tozinameran, substantially bigger than Moderna's - & the most international one. And co-primary endpoints are for moderate to severe Covid-19, including 1 at a month - which is longer than we've seen previously...2/5 Image
...You can see the protocol for the trial here: jnj.com/coronavirus/co… (Note, it was originally for 60,000 but they got so many events it was cut back to 40)...3/5
Read 6 tweets
Hilda Bastian, PhD Profile picture
17 Jan
After 10s of thousands of Brazilians participated in early trials of Covid vaccine, vaccination has at last begun there: Anvisa (drug regulator) approved Sinovac's CoronaVac & Serum Institute of India's Covishield (Oxford/AstraZeneca vaccine) ...1/n g1.globo.com/sp/sao-paulo/n…
...Before I get to the Anvisa documentation, important update on the alligator tracker: jacare-tracker.org It's tracking Brazilian as well as global vaccinations & it's now on Twitter too @jacaretracker ...2/n
...Anvisa's documentation is here & includes trial data as well as manufacturing standards reports: gov.br/anvisa/pt-br/a…

CoronaVac data for the Brazilian trial only. 12,123 people in the whole trial: 64.3% female, 4.9% 60 years or older. Median age: 37 (for Pfizer: 52)...3/n
Read 13 tweets
Hilda Bastian, PhD Profile picture
16 Jan
Oh my... Remembering this time 4 years ago. I was living in DC. I flew back in the night before the inauguration with my 2-yr visa freshly updated: its expiration was my personal deadline to be living back in Oz. Taxi from airport was the first clue of what was coming...
...So many barricades & security, taxi from the airport had to try many routes to get me to my apartment in the middle of DC. Lots of Trump supporters whooping it up. But there were so many women, too....
...Dragged myself, mega-jetlagged, out to the Women's March - and women were streaming everywhere. I'd been to big demonstrations before, but I never saw one as big as this...
Read 5 tweets
Hilda Bastian, PhD Profile picture
12 Jan
Press conference on results of Brazilian trial of CoronaVac, Sinovac's inactivated vaccine, cleared up the efficacy data & made the complexity of comparing a trial in healthcare professionals with others *really* clear: are they better at self-diagnosing Covid-19 symptoms?...1/n
...That's a central question now: does this trial capture more much "milder" infections than the others we've seen? They're suggesting it does & that drives down the apparent efficacy rate. Here's how the data plays out...2/n
...The trial's definition of symptomatic Covid-19: the first is a slide from the press conference (Portuguese), the second is from the English version of the trial protocol. The primary efficacy endpoint is regardless of whether the person had previous SARS-Cov-2 infection... 3/n
Read 13 tweets
Hilda Bastian, PhD Profile picture
11 Jan
Indonesia issued emergency use authorization for Sinovac's CoronaVac; spokesperson for BPOM (drug regulator) said the efficacy rate in the Indonesian phase 3 trial was 65% (trial of 1,600 people). jakartaglobe.id/news/indonesia… HT @bayukariastanto ...1/2
...Indonesia's decision was based on the vaccine having above the 50% minimum vaccine efficacy set by the WHO - while the virus is out of control in Jakarta.

Records on this vaccine: zotero.org/groups/2528572… 2/2
...The BPOM spokesperson, Penny Lukito, also announced that CoronaVac has been certified Halal. halosemarang.id/bpom-terbitkan…
Read 4 tweets
Hilda Bastian, PhD Profile picture
7 Jan
Some results from Brazilian phase 3 trial for Sinovac's inactivated Covid vaccine CoronaVac released at a press conference. Vaccine efficacy for mild symptomatic Covid-19: 78%, similar in people under & over 60 years. 0 moderate/severe/hospitalized... 1/n g1.globo.com/bemestar/vacin…
...For background: it's a trial in healthcare workers. The protocol was published here: trialsjournal.biomedcentral.com/articles/10.11… Collection of records on this vaccine here: zotero.org/groups/2528572… ....2/n
...Currently buying it from China, US$10 a dose: more than the Oxford vaccine ($3), half of Tozinameran (BNT/Pfizer). However supply of Oxford vax uncertain, whereas they already have drug regulator clearance for local manufacture of CoronaVac... 3/n www1.folha.uol.com.br/equilibrioesau…
Read 9 tweets

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