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…
...2nd: a claim of efficacy of 79.4% based on a group of people who failed to get the 2nd shot in Russia's vaccination program. They've made claims on the basis of this data before - it's linking a register of vaccinations with a register of people diagnosed with Covid-19..4/n
...Less than 3% of the whole population has had Sputnik V, according to a previous press release, & the proportion of those that didn't get the 2nd shot are obviously highly likely to have major differences to the rest of the population ...5/n
...Nevertheless, that's the basis of the claim of efficacy: the rate of infection shown for people who aren't vaccinated at all in the whole of Russia vs the rate of infection of people who didn't get the second Sputnik V shot...6/n
...And a 3rd claim: "Sputnik Light has proven effective against all new strains of coronavirus, as demonstrated by the Gamaleya Center during laboratory tests." As far as I know, none of this is public. Whereas here's a preprint ...7/n
...that found 8/12 serum samples from people vaxed with Sputnik V had signs indicating failure to neutralize B.1.351 ("SA" varian), etc medrxiv.org/content/10.110… ...8/n
...Press release states 20 million doses of Ad26 used globally with no cases of Cerebral Venous Sinus Thrombosis (CVST) reported. Given it occurs even without vax, lack of reporting can't be taken as evidence of absence.
Can't think of anything diplomatic to say about this.
9/9
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
...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
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