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
...First the data for the results they reported at the previous press conference. The data are for 9,242 participants. For people needing hospitalization or having severe Covid-19, there were 0 cases with CoronaVac, ...4/n
...Next level is the one they reported last time, the 78% efficacy. It wasn't the primary efficacy outcome. It was for people who needed medical assistance as well as the people hospitalized or severely ill: with a confidence interval from 46% to 90% - a lot of uncertainty...5/n
...This is new: the overall efficacy. They believe while they don't have asymptomatic infections, they have tested for & captured more symptomatic infections than others could. That's a vaccine efficacy rate of 50.38%, CI of 35-62%. So just scraping over the WHO requirement...6/n
...How does this compare? I don't think the press conference revealed age split, but someone who speaks Portuguese might be able to say. Protocol set an overall target of about 10% of people over 60. Oxford/AstraZeneca came in at ~60% efficacy for up to age 55. Which means...7/n
...Brazilian trial, roughly same size & similar-ish confidence intervals, has more people at risk of (severe) Covid-19 & less likely to have strong immune response. Hard to know if it's similar, lower or higher than Oxford. We don't know the efficacy over time for CoronaVac...8/n
...Where does this leave us? I think they made an important point about self-diagnosis of symptoms in a healthcare worker (HCW) trial. The Turkish trial is also for HCWs, similar size, but we don't have the protocol for it, so don't know how otherwise similar...9/n
...Explanation for a previous tweet: when I said "similar CIs", I meant the range was as wide, not the same actual results.
...PS (always at least 1!!!): This time it's about the numbers. The number for the 2 groups in the slides they gave don't add up to the 9,242 in the slides: they add up to 9,252. I think this means we have to wait for a proper report to be *really* sure about the numbers.
...About the Brazilian trial for CoronaVac (Sinovac vaccine) for those asking. If participants reported symptoms of Covid-19, they were tested: but if they didn't report symptoms, they weren't.
• • •
Missing some Tweet in this thread? You can try to
force a refresh
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.
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…
...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…
MHRA's (UK drug regulator) 57-page Public Assessment Report on Oxford/AstraZeneca vax is out: assets.publishing.service.gov.uk/government/upl… 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
Statement from the UK Joint Committee on Vaccination & Immunisation (JCVI) on why they believe their strategy will achieve maximum impact: app.box.com/s/uwwn2dv4o2d0… 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 bloomberg.com/news/articles/… For the Oxford/AstraZeneca vax, they rely on a subgroup analysis - but the data isn't provided...3/n
#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 aai.org/About/History/…
...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
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... livemint.com/science/health… 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