... Typo in previous tweet: 141 events. (No confidence intervals provided.)
....2/n
...Vaccine efficacy was consistent across ethnicity & age, include older. It was 80% for people aged 65 & older.
No breakdown of events by vaccine & placebo...3/n
...No one had CVST in this trial (although with only 30,000, you wouldn't expect any either, based on the European experience)...4/n
...This is still a younger group than the mRNA trials - 20% are 65 & over. It's going to very interesting to see the eventual breakdown of solicited adverse events for younger & older when we get final results...5/n
...Ah...doesn't seem they have an indication from this trial on whether it could increase over time, so my first tweet was over-optimistic there. Doesn't matter: 79% is high efficacy. Just shows how important having a good big trial is, doesn't it? ...6/n
... I don't know if we'll ever know, but as I tweeted, been wondering if there'd be an impact from not having placebo control. Going to be an interesting question for the future
PS: I've been alerted by @BertrandBio (TY!) that I may be wrong on comparability of age groups with the mRNA vaccines, so please ignore that part of a tweet above. (Still interested in breakdown of adverse events by age, though.)
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...As usual, in-depth look at quality of manufacturing. "No raw materials of human or animal origin are used" in the final production. The cell line used to optimise production of the vaccine vector is PER.C6, which has already been studied for safety...2/n
...Current batches manufactured mostly in Leiden & emerging in Baltimore: they've shown consistency in the European manufacture - EMA wants them to follow-up with data showing the Baltimore production is comparable (this is all standard) ...3/n
Out of the several different major vaccination strategies internationally, the UAE's is one of the most unusual. There are 4 vaxes available (Sinopharm Beijing, BNT-Pfizer, Sputnik V, Oxford-AstraZeneca), & free vaccination now open to everyone 16+ khaleejtimes.com/coronavirus-pa… ...1/n
... When you apply for an appointment, you choose the vaccine you want.... "Press 1 for Sinopharm...."
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
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).
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
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