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Phase 3 trial for Sputnik V results landed!
To keep in mind: randomized 3 to 1 (not half in vax group, half placebo). It's a pair of vaccines, 1 shot of each, not same vax twice. Both are adenovirus vector vaccines - same category as Oxford & J&J... 1/n https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00234-8/fulltext
To keep in mind: randomized 3 to 1 (not half in vax group, half placebo). It's a pair of vaccines, 1 shot of each, not same vax twice. Both are adenovirus vector vaccines - same category as Oxford & J&J... 1/n https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00234-8/fulltext
...We never saw a protocol for this one previously - and there isn't one released with this paper either... 2/n
...They measured their primary outcome from 21 days after the *first* vaccine (the shots are 21 days apart).
These people are at comparatively low risk of poor Covid-19 outcomes: 99% white; about 90% aged 60 or under; <1% at high risk of infection...3/n
These people are at comparatively low risk of poor Covid-19 outcomes: 99% white; about 90% aged 60 or under; <1% at high risk of infection...3/n
...Primary efficacy analysis high, as expected from their trial readout press release. 16 people with Covid-19 in 14,964 vaccinated (all mild); 62 in the 4,902 people in the placebo group (20 moderate or severe): 91.6% efficacy (CI 85·6–95·2). >60yrs: 91·8% (CI 67·1–98·3) ...4/n
... OK, this is new info if you've read my latest blog post: adverse events. No serious adverse event (SAE) judged by their data monitoring committee as vaccine-related ...5/n
...2 people in the vaccine group died of Covid-19: judged infected before they were vaccinated (although they had negative PCR tests at trial entry). Both got sick 4-5 days after vax. Both had health problems. 1 death in the placebo gp - but I can't see a cause reported...6/n
...Adverse events (AEs): we *really* need a protocol or at least a better description of the methods in the paper. They do not report on solicited AEs & I think it's fair to say they didn't solicit any: - people were offered an e-diary to record symptoms, but not required...7/n
...which means we really don't know the rate of adverse events for this Sputnik V. They list the detail of those events that were reported, but this is a methodological problem - & a problem for informed consent, too. Unless they have the data & just aren't including it here..8/n
...(& that's possible - the Lancet paper for the Oxford/AstraZeneca didn't include adverse event reporting either), then this is presumably going to be a problem at EMA too. But let's assume they have it & didn't report it: also not a good sign. :( ...9/n
...This is a really thin trial report. (11 pages of article, 16 in the appendix) So it's not surprising that I can't find lots of what I'm looking for... :( ...10/n
... Let's go back to efficacy. Everyone got a PCR test at 21 day visit before 2nd injection. They seem to have relied on Moscow's electronic health record system for Covid ascertainment quite a bit (trial participation was in the EHR). I can't speak to the quality of that...11/n
...The study was run by the Moscow branch of a Dutch CRO (contract research organization): Crocus Medical. Without seeing a protocol (sorry to harp on that, but it's really needed here), hard to know if things were more thorough than reported here...12/n
...They include this about the protocol: not reassuring....13/n
...Here's that same data again: it's the argument for Sputnik Light (1st shot only), basically - the protection came from that 1st shot (the adenovirus 26 one). Lots to chew on here now there are 3 viral vector vaccine results out...14/n
...There were 5706 people in the vaccinated group for whom they hadn't yet analyzed the adverse events data - there'll be a separate publication later: another caveat for the AE data reported here ...15/n
...The vaccine tested in this trial was kept colder than normal refrigerator, but it has been approved for distribution at fridge temp. More on that isn't reported. There are small ph 3 trials to go in UAE & Venezuela, so presumably that will be at the lower temperature?...16/n
...In the discussion: person's death in placebo gp not Covid-related. Appendix details illnesses & deaths of the 2 people with Covid before the vaccine could have provided protection.
So - it seems to be a very high efficacy vaccine, with a not-so-great trial...17/n
So - it seems to be a very high efficacy vaccine, with a not-so-great trial...17/n
...Unless the paper doesn't do the trial justice, which of course is fully possible, it could have a hard time in an evaluation at the level of EMA's one for Moderna. /18
And the obligatory PS: @talousmuumi found the cause of death in the placebo group on page 8 - hemorrhagic stroke. (TY)
