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).… 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:… 2/2
...The BPOM spokesperson, Penny Lukito, also announced that CoronaVac has been certified Halal.…
...6 vaccines in addition to CoronaVac apparently authorized for Indonesia: Moderna, Novavax, Oxford/AstraZeneca, Sinopharm, Tozinameran (BNT/Pfizer).… HT @Stephanus_SJ

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More from @hildabast

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 ImageImage
Read 11 tweets
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…
...For background: it's a trial in healthcare workers. The protocol was published here:… Collection of records on this vaccine here:… ....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…
Read 9 tweets
5 Jan
MHRA's (UK drug regulator) 57-page Public Assessment Report on Oxford/AstraZeneca vax is out:… Like Oxford's publication, does not mention phase 3 trials in US & India (& so its serious adverse event), so not clear this is a selective trial report... 1/n
...Quality assessment of the drug & manufacturing facilities based on manufacturer reports & certifications, not MHRA inspections. Presumably as with Tozinameran (BNT/Pfizer vax), this would be done by the European Medicines Agency (EMA)...2/n
...Independent Batch Testing for the vaccine is undertaken UK National Institute for Biological Standards and Control (NIBSC). Temperature requirements confirmed (does not need super-freezing) ...3/n
Read 19 tweets
31 Dec 20
Statement from the UK Joint Committee on Vaccination & Immunisation (JCVI) on why they believe their strategy will achieve maximum impact:… 1/n
...They point out that most of the people who got sick with Covid-19 between 1st & 2nd doses of Tozinameran (BNT/Pfizer vax) did so in the 1st 2 weeks, so the efficacy after 2 weeks was 89% (95% CI 52-97%). But Pfizer stresses... 2/n
...that's only known for people who got their booster shot at 3 weeks, so it's unknown if it stays high for up to 3 months… For the Oxford/AstraZeneca vax, they rely on a subgroup analysis - but the data isn't provided...3/n
Read 5 tweets
30 Dec 20
#tbt This is the amazing Anna Wessels Williams (1863-1954) in the early 1900s. Her sister nearly died in childbirth in 1887: distressed by her treatment, she entered medical school. She moved to lab work in 1894: her 1st major breakthrough came fast ...1/4…
...While her boss was on vacation, she solved the barrier to high-yield diphtheria vaccines. She followed that with a 2-year sabbatical at the Pasteur Institute, creating a rabies vaccine that would be mass-produced in the US. Next was a rabies test in 1905 used for decades...2/4
...She was on the frontlines of the 1918 influenza pandemic, developed a more accurate diagnostic test for trachoma, & co-published a major textbook as well as one of the early successful science books for the public in 1937 ... 3/4
Read 4 tweets
29 Dec 20
Well, dear readers, my take on "the winning formula" for Oxford/AstraZeneca did not age well. According to the Indian manufacturing partner, it isn't the "low"-dose-1st subgroup. It's another subgroup, perhaps a subgroup of a subgroup...… HT @wogboy11 ..1/6
..The sweet spot he says is "a 2-to-3 months’ gap between dose 1 & dose 2". First let's recap their original data. They said intervals didn't make a difference. For the "standard"-"standard" group >8 wks apart vaccine efficacy was 65·6% (24·5 to 84·4). Ditto 6 weeks cutoff ..2/6
...The protocol doesn't limit the possible exploratory subgroup analyses ⬇️: so many ways they could have found a subgroup that hit this mark. Eg half the already-small "low"-dose-1st group had >12 wks apart: sliced off those perhaps? But I don't think that's the main point ..3/6
Read 6 tweets

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