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...
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
...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
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
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