news about the medigen vaccine from Paraguay. Anybody who can translate? Says its better than AZ?
Not me, but I was reading the clinical trial summary the other day and a bit surprised that one of the two primary outcome measures was assessing the incidence of adverse events…using 471 people. Lol.
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Is ETtoday Deep Green or Deep Blue?
Maybe they expect so many adverse events that 471 people is sufficiently powered? 
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I also found it more than a bit weird that the number of Medigen recipients in Taiwan is presumably now a few orders of magnitude higher than that in the study nominally evaluating adverse effects (I know I could go over to one of the vaccine threads to check how much higher, but I’m on my phone and…nah).
I guess this will be widely reported in Taiwan as Medigen being 3.7× “better” than AZ, although I’m still curious how valid immunobridging is for different vaccines (it doesn’t seem to be standard, with most other studies apparently just using it for the same vaccines but different age groups). It seems like the MHRA recently accepted it (if I’m reading “cross-platform” correctly), as long as some additional stuff is provided. 
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You could make the same observation about the 10 billion doses of other vaccines that have been handed out, with virtually no interest in what happens to people subsequently. You would have thought, given the novel nature of these products, this would be an ideal opportunity to conduct research. A lot of the subjects aren’t even volunteers, which does wonders for your subject randomization
Simple explanation:
Superiority in this case refers to a science term. It just says that the study was made comparing to a standardized treatment. The results showed the fact that Medigen produced over 3 times the amount of antibodies in the recipients.
French drugmaker Sanofi and its British partner GlaxoSmithKline are seeking regulatory approval for their COVID-19 vaccine to be used as a booster, as well as a standalone two-dose shot - saying tests indicated it was 100% effective in preventing severe disease.
Following several setbacks for the companies, they said they intended to submit data to regulators from a late-stage trial of the vaccine, and another testing it as a booster, with full results for both studies expected to be published “later this year”.
Sanofi, which plans to produce the vaccine in France, Italy and the US, is hoping for a comeback after falling behind in the race for COVID-19 shots, while GSK, the world’s biggest vaccine maker by sales, has not developed its own candidate and is instead contributing its adjuvant technology to developers.
Sanofi-GSK’s jab relies on a conventional protein-based approach, compared with the newer mRNA technology used in established COVID-19 vaccines including Pfizer-BioNTech and Moderna.
The companies said final analysis of the booster trial, which included participants previously given shots based on mRNA technology or adenovirus viral vectors, showed it could increase neutralising antibodies by 18 to 30 times.
“We are confident that this vaccine can play an important role as we continue to address this pandemic and prepare for the post-pandemic period,” said president of GSK vaccines Roger Connor.
Early data from the late-stage trial of the vaccine as a standalone two-dose shot showed it was 100% effective against severe COVID-19 and hospitalisation, with 75% efficacy against moderate or severe disease.
(COVID live news: New vaccine '100% effective against severe disease' - as latest UK deaths and cases figures revealed | UK News | Sky News)
“No other global Phase 3 efficacy study has been undertaken during this period with so many variants of concern, including Omicron, and these efficacy data are similar to the recent clinical data from authorised vaccines,” said Thomas Triomphe, executive vice president for Sanofi Vaccines.
100% effective against severe disease? A bit late to the party I would say, the excitement is over.
This thread has been quiet for a while. Here’s some Moderna news forumosans may be interested in:
Guy
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And a few months later, here’s some more moderna news.
I’ve only skimmed the paper - I’ll have a proper look when I have time - but they appear to have made a sensible attempt to compute “excess adverse events”, ie., taking into acount the background rate and Covid-linked rate of weird things happening to people, how much more frequently does bad stuff happen after being jabbed? The answer seems pretty clear: for Moderna at least, you’re playing a gambling game with high risks and no payback.
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Senator Rand Paul further exposing Fauci:
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Got the antibody cocktail just,now; should give me some protection for 6 mos. Available to the moderately to severely (me) immuno-impaired. $100 NT. Gotta love Taiwan!!!
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I suppose this counts as a “new development” of sorts . . .
Guy
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First of all, Singapore approved Moderna’s booster last month. Singapore approves Moderna's first bivalent Covid-19 booster jab
Secondly, “the next-generation bivalent vaccine was tested by both manufacturers in clinical trials on subjects aged 12 and over.” I don’t know about Moderna, but we know Pfizer only tested the booster on 8 rats. ROFL.
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Mr Comedy, it seems you are confused. The Moderna bivalent shot approved by Singapore in September is the same bivalent shot that’s currently being administered here in Taiwan: the one that combines the “original recipe” with one tweaked to deal with BA.1 and BA.2. The approval of this vaccine is not news.
The newly approved Moderna bivalent vaccine is by contrast the one that has been rolled out in the US and so far nowhere else. This one combines the “original recipe” with one tweaked to deal with BA.4 and BA.5.
It appears that this latter vaccine will be en route in November, and it will have a wider use for folks 12 and older. (The current bivalent vaccine, by contrast, is only approved for 18 and up.)
Guy
Pfizer outlined data relating to both BA.1 and BA.4/5 booster vaccines. This included a clinical study in which 640 participants were given a booster dose of the BA.1 bivalent vaccine (page 11), along with preliminary data from eight mice given two doses of the BA.4/5 bivalent vaccine (page CC-25).
Andrew Pekosz, a professor in molecular microbiology and immunology at John Hopkins University, also confirmed the BA.4/5 booster was approved based on a number of different parameters, including human data from the BA.1 bivalent vaccine.
Animal trials are a normal process testing vaccines.
Yearly influenza vaccines are tested on ferrets.
There is no time for thorough clinical trials of influenza vaccines on humans every year before the virus spreads. But they are determined to be safe because they are similar to previous vaccines.
Clinical trials on humans are done and evaluated as soon as possible.
Antigenic characterization plays an important role in early assessments of how well vaccine may work by looking at how well ferret antibodies can target and neutralize circulating flu viruses. Because the ferrets used in antigenic characterization testing have never been vaccinated or infected with influenza previously, they produce very specific and narrowly focused antibodies. However, one limitation of antigenic characterization data from ferrets is that it does not account for the human experience and how people’s prior flu infections and vaccinations can influence the way their immune systems respond to current flu vaccines.
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What a comparison!!! When’s the last time you’ve seen an EUA accompanying a flu shot?
From the article: "The Food and Drug Administration (FDA) on Wednesday (Oct. 26) said that it had issued emergency use authorization (EUA) for the two adapted bivalent vaccines that target the BA.4 and BA.5 subvariants of Omicron. "
Drugs against influenza have received Emergency Use Authorization (EUA)
October 23, 2009, Food and Drug Administration (FDA) Commissioner Margaret Hamburg issued an Emergency Use Authorization (EUA) for peramivir for intravenous injection (BioCryst Pharmaceuticals). Peramivir is an unapproved investigational neuraminidase inhibitor that may be effective in treating certain hospitalized adult and pediatric patients with suspected or confirmed cases of 2009 H1N1 influenza. The EUA allows health care providers to use peramivir, subject to specified conditions. This is the first EUA that has been issued for an unapproved drug.