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 only other data on the booster. They're working on a variant-alone booster, & a bivalent version (an injection of the original vax plus variant-booster)...4/n
...Other news:
- 1st dose of Novavax in the UK COM-COV vax combo trial was on April 9.
- 1st dose in pediatric trial in the US was on April 26.

...5/5

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More from @hildabast

6 May
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…
Read 10 tweets
5 May
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… Image
...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
Read 5 tweets
5 May
Sinopharm's presentation on their Beijing vaccine to WHO's expert committee is now online: cdn.who.int/media/docs/def… 1/n HT @AlejandrodeBar1
...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
Read 12 tweets
3 May
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)

cdn.who.int/media/docs/def… ...2/n
...- Efficacy against hospitalization: 78.7% (CI 26-94)
- 1 death only, in the placebo group

But this is only up to age 60: negligible people over 60, & none had Covid-19 (in vax or placebo group)
...3/n
Read 25 tweets
29 Apr
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 ..1/n
...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
Read 10 tweets
26 Apr
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
Read 13 tweets

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