...Includes this overview of preclinical toxicity studies. (Note, they've also published this study on some preclinical work tandfonline.com/doi/full/10.10…) ...2/n
...The phase 3, #4Humanity trial in the Middle East - here are the blood collections taken across all the countries. (No answer here to the question of whether there were regular tests for Covid-19 in the UAE part of the trial)...3/n
...Breakdown of participants by country: about 11,000 people from outside the UAE...4/n
...Breakdown of participants just in the Beijing vaccine & placebo arms. <14% non-Asian. (Would have been helpful to see this defined, but we haven't seen a protocol for this trial yet)...5/n
...2 doses were 3 weeks apart, vaccine efficacy calculated from 14 days after the 2nd dose:
- Against Covid-19, 78.1% (CI 76-86) - *appears not to be only symptomatic Covid-19*
- 0 severe Covid-19 in vax group, 2 in placebo
...6/n
...I wish this was explained here or in WHO summary. Rate against asymptomatic infection only - doesn't say how that was detected:
- 50.4% (CI: -2 to 76) (11 in vax group, 22 in placebo)
Listed under subgroup analyses, implying the overall efficacy isn't only symptomatic ...7/n
...Solicited adverse events for the whole group. Placebo is blue: higher than vax for mild (grade 1) events. No difference for other levels of events. This is such a low rate rate of adverse reactions to Covid vaccine injections...8/n
...Incidence of adverse events displayed in 3 time periods (blue is placebo) ...9/n
... Serious adverse events (SAEs). In 2 people, they were vax-related, but events not described. (My explainer on the language of AEs: absolutelymaybe.plos.org/2021/02/21/a-r…) ...10/n
...Very few people aged 60+ in this trial. Here are neutralizing antibodies in a small subset of the under-60s vs most of the vaxed aged 60+ (172 out of 294).
So a larger proportion of older people would seem likely to have reduced overall vaccine efficacy ...11/n
...There's a post-marketing study for 9,800 people in Mozambique for Beijing vax, with co-administration (but it doesn't say what - flu vaccine?). If anyone knows more details of this study, please let me know!
They thanked the research participants at the end. #4Humanity 12/12
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They've registered Sputnik Light in Russia, again on very thin data, again not waiting for phase 3. It's not a new vaccine: it's the 1st half of Sputnik V - an adenovirus 26 shot. Given the production problems since early on with the other half (Ad5)...1/n sputnikvaccine.com/newsroom/press…
...it's not surprising. (The Ad5 shot is the one there was a lot of controversy about recently because of replication-competence.) So it becomes a single-shot adenovirus vax (like J&J's & CanSino's) & it's half the price: full Sputnik V was expensive for Covid vax...2/n
...The data basis? 3 things: Immunogenicity results of a phase 1/2 trial with 110 people - some outcomes summarized in the press release only. Here's the trial register entry for it...3/n clinicaltrials.gov/ct2/show/NCT04…
Results of an analysis of adverse events after Sputnik V vax in San Marino. From those vaccinated early, so some healthcare workers & mostly older people. Median age 68, so a much lower rate would be expected than for a general population ...1/n (Preprint) medrxiv.org/content/10.110…
...Everyone who got vaccinated was invited to participate, but it appears to have had a very low response rate: eg 1,946 out of 8,799 aged 60-89 did (22%): nothing reported to gauge how similar they were to those who didn't. Total group is 2,588, of whom 1,288 had both shots..2/n
...People were contacted 7 days after vaccination, then at 1 month & 3 months. So there would be more recall bias than in a trial with a diary method, but less recall bias at 7 days than for later data...3/n
Oh my! Detail on adverse events in the Novavax UK trial included in a conference presentation - wish the numbers were there: definitely less than Moderna. Will need to blow this up & try to work it out! ...1/n novavax.com/sites/default/… HT @londonboyjohn
...A reminder of the vaccine efficacy rates for the phase 3 trial in the UK & the 2b efficacy trial in South Africa. It's an adjuvanted protein subunit vaccine...2/n
...They've made a booster aiming at the B.1.351 variant of concern. Here you see responses in baboons that had been immunized with the original a year ago. Bonus: you see with & without their adjuvant (same one used in the recently reported malaria vaccine) ...3/n
The evidence assessments - but not the WHO decisions - for Sinopharm's Beijing vax & Sinovac's CoronaVac are going up on the WHO website who.int/news-room/even… HT @lutl88@hvasquezhg ...1/n
...Sinopharm Beijing: WHO assessment. 45,000-participant trial in UAE/Bahrain/Egypt/Jordan, doses 21 days apart, efficacy:
- Overall: 78.1% (CI 65-86)
- For people with no previous infection: 80.8% (67-89) (the usual efficacy rate for others)
Anvisa (Brazil's drug regulator) just held a press conference on Sputnik V, including responding to the developers' allegations about their assessment & decision. You can see it here Live-tweeted (in Portuguese) by @jasonptodd
...They confirmed the presence of replication-competent adenovirus in Ad5 (2nd shot) batches wasn't a finding of their own batch testing - it was reported to them by Gameleya (developers of Sputnik V), who had apparently set a high level of acceptable replication-competence...2/n
...for the Ad5 shot (but not for the 1st, Ad26, dose). They pointed to the US FDA standard for this, here: fda.gov/media/113760/d… That's what they expected Gamaleya to certify. However, apparently Gamaleya set the level at 300, not 3 ...3/n
Anvisa (Brazil's drug regulator) has just announced it has denied the request to import Sputnik V vaccine because of absence of data & issues with the development of the vaccine, including vax quality. g1.globo.com/bemestar/vacin… Meeting still streaming ..1/n
...Unanswered questions about the vaccine include basic biological data about its actions in the body, data on adverse events (including questions about thromboembolic events) ...2/n
...I think with all the focus on Lancet paper for phase 3, people forget how little study there had been of this vax: eg only 38 people in phase 1/2 trial version with lots of problems. (absolutelymaybe.plos.org/2020/09/11/pha…) Assessing a vaccine isn't only about the phase 3 trial results...3/n