For those who don't recognize the author, he is a well-known biochemist working in pharmaceuticals whose blogs are generally very well informed and well worth the read.
I'd like to believe we will start mass manufacturing all promising candidates long before testing is complete.
The stakes are so high this time that it's important _as soon as_ testing results are deemed adequate, they can start distributing them, even if it means manufacturing stuff that doesn't ultimately pan out.
I want to point out that 5 vaccines (out of 78) are in phase 1 trials (4 of those actively looking for volunteers, visit clinicaltrials.gov links below to see if you qualify):
4. LV-SMENP-DC (Dendritic cell modified with lentiviral vector expressing synthetic minigene based on domains of selected viral proteins; administered with antigen-specific cytotoxic T lymphocyte) by Shenzhen Geno-Immune Medical Institute: https://clinicaltrials.gov/ct2/show/NCT04276896
5. Pathogen-specific artificial antigen-presenting cell (aAPCs modified with lentiviral vector expressing synthetic minigene based on domains of selected viral proteins) by Shenzhen Geno-Immune Medical Institute: https://clinicaltrials.gov/ct2/show/NCT04299724
The history of rushed vaccines is not good. The first attempt at a polio vaccine was rushed through with inadequate safety measures and resulted in 40,000 children getting sick, some with permanent paralysis.
There are good reasons vaccines take years to be approved. I’m very worried we’ll see a repeat of historical mistakes in the current rush.
No that it matters, but it wasn’t a safety issue with the vaccine, but a manufacturing issue. The vaccine was perfectly safe, it just wasn’t manufactured to the correct specification.
I might be wrong, but I thought any human trial needs at least a full one-year follow-up to make sure that the vaccine didn't cause any damage, side effects, reactions, etc, and that indeed created long term immunity.
It seems to me that rushing the timelines potentially opens up a lot of risks for post-vaccine side effects. Doesn't it?
That's what the article says, human trials in fall this year and then a regulatory filing a year later. There is basically no chance of a vaccine for this being widely available before 2022. That assumes that one of these vaccines works, despite no vaccine for a coronavirus ever passing regulatory approval (hence this is a hard problem, and plenty of incentive to vaccinate against things like common cold which would be a nice money earner for a someone).
>I thought any human trial needs at least a full one-year follow-up to make sure ...
Depends what you mean by "need". If you're talking about a risk/benefit calculation for getting a vaccination, I expect it will play out very differently for high-risk elderly folks vs low-risk young adults.
That's a type of vaccine. If you want to figure out how safe and effective it is, you need to run a clinical trial. Same as amy other vaccine. If you got started now, you'd be running behind some of the other approaches that are already in clinical trials, so, um, get started fast?
Most likely very effective especially if you were to find a strain that didn’t make you seriously ill. Pity nobody seems interested in actually finding such a strain.
He discuses that in his blog. There are 2 types of such vaccines.
Live ones, that are exactly like you said, low infectious strain, and dead ones, where they kill the virus and it sometimes still produces correct antibodies.
there are several of such types of vaccines in development
> Roughly estimated, even a seasonal flu vaccine might kill about one out of every ten million recipients though such a reaction – we give it to everyone possible, though, because far more people will die if we don’t.
Yeah that’s frightening, but really true? I’ve never heard of a single person dying from the flu vaccine locally.
The numbers involved are just so hard to imagine. Even if we create a vaccine as safe as flu shot it will kill on the order of 1000 people worldwide (1:10m). We have to hope that they will be randomly distributed and not the first volunteers who take it...
I worry that the vaccine won't be effective. To stop this coronavirus we basically have to quarantine and stop human activity for a few months. We are already down that rabbit hole so we just need to stay the course and really isolate as much as we can. The govt is going to have to help people to get through the next 6 months.
So what happens when we end quarantine in 6 months? We'll just have a COVID epidemic 6 months from now. Isolation does not stop the spead, it only slows the spread.
As soon as isolation is lifted, whether that be in a month or 10 years, the spread will resume. Unless of course either a) herd immunity is developed or b) a vaccine is developed.
As a lay person, I found this to be a very informative article.
One thing I didn't see mentioned was a recent article that caught my attention - apparently, tobacco may be used as means of production for a potential vaccine [0].
Given that the linked article was published on April 1, I initially thought it to be satire. Upon further consideration, though, it not only seems to be genuine but it makes sense: tobacco is likely one of the best understood plants from a genetic standpoint, with a long history of successful genetic modification using both traditional and modern approaches. It's certainly one of the best understood that also has large-scale production capabilities, and I would imagine that the tobacco industry has more incentive than most to seek the positive PR that this could bring.
Finally, setting aside the greater political context, it seems to me that the FDA under the Trump administration is more flexible and risk-tolerant than any point in my lifetime (and perhaps in living memory). There are certainly many challenges that will have to be overcome before we get to the point that we're able to widely roll out an effective vaccine, but I strongly suspect that this flexibility will result in a speed of development and approval that will surprise many of us. Of course, that speed will come with associated risks, but that's just the nature of things.
I would not be surprised to see widespread voluntary human testing of promising vaccine candidates in the next six months - perhaps even sooner if a promising candidate ends up being derived from the past few years' work in creating a vaccine for SARS-CoV-1.
I am really concerned about the fact that the FDA is trying to fast track stuff.
I just want to offer a perspective of why this is dangerous. We are having some serious issues with flouroquinolone antibiotics. The side-effects of the medication are insane and under-reported. 9 years ago I was given the antibiotic for an infection, my body went into shock, I was released the next day with some odd neurological issues. None of it reported to the FDA, few months later I got tendon pain. I go to mayo clinic, they disagree the antibiotic caused it. Seen 30+ physicians in the span of 2 years, 2 agreed that it is possible. One of them said to wait it out, and refused to actually put it in my chart. The antibiotics carry a 'black label' and clearly state side effects may occur up to 1 year. I reported it to the FDA, then I found groups of people suffering from chronic fatigue, tendon raptures, weird neurological symptoms, some had diagnosis of 'fibromyalgia', some had chronic tendinitis, yet after reviewing their medical information they found they took a flouroquinolone antibiotic but nobody ever even suggested that it could be that.
This bring me to Tamiflu fiasco. Governments have spent billions of dollars to purchase Tamiflu to fight the flu. Later reports came out about issues with the studies, the maker picking positive studies and withholding neutral or negative information. It has not proven much better than the drugs we already use to treat the flu.
Fast tracking a medication can have terrible results, cost billions of dollars, and cripple hundreds of people. Doing any scientific research with panic in the back of your mind and high pressure from politicians and people is dangerous IMO. Especially, in a profit driven healthcare system.
[+] [-] btilly|6 years ago|reply
Also sometimes extremely funny. Read https://blogs.sciencemag.org/pipeline/archives/category/thin... for good examples of that.
[+] [-] dmoy|6 years ago|reply
https://blogs.sciencemag.org/pipeline/archives/2010/02/23/th...
[+] [-] dmix|6 years ago|reply
https://twitter.com/bio_clouseau
[+] [-] danieltillett|6 years ago|reply
[+] [-] truantbuick|6 years ago|reply
The stakes are so high this time that it's important _as soon as_ testing results are deemed adequate, they can start distributing them, even if it means manufacturing stuff that doesn't ultimately pan out.
[+] [-] folli|6 years ago|reply
[+] [-] bolasanibk|6 years ago|reply
[+] [-] ignoramous|6 years ago|reply
1. mRNA-1273 (lipid nanoparticle encapsulated mRNA vaccine encoding S protein) by Moderna: https://clinicaltrials.gov/ct2/show/NCT04283461
2. Ad5-nCoV (Adenovirus type 5 vector that expresses S protein) by CanSino Biologicals: NCT04313127.
3. INO-4800 (DNA plasmid encoding S protein delivered by electroporation) by Inovio Pharmaceuticals: https://clinicaltrials.gov/ct2/show/record/NCT04336410
4. LV-SMENP-DC (Dendritic cell modified with lentiviral vector expressing synthetic minigene based on domains of selected viral proteins; administered with antigen-specific cytotoxic T lymphocyte) by Shenzhen Geno-Immune Medical Institute: https://clinicaltrials.gov/ct2/show/NCT04276896
5. Pathogen-specific artificial antigen-presenting cell (aAPCs modified with lentiviral vector expressing synthetic minigene based on domains of selected viral proteins) by Shenzhen Geno-Immune Medical Institute: https://clinicaltrials.gov/ct2/show/NCT04299724
Ref: https://www.nature.com/articles/d41573-020-00073-5
[+] [-] jdsully|6 years ago|reply
There are good reasons vaccines take years to be approved. I’m very worried we’ll see a repeat of historical mistakes in the current rush.
https://en.m.wikipedia.org/wiki/Cutter_Laboratories#The_Cutt...
[+] [-] Jommi|6 years ago|reply
[+] [-] danieltillett|6 years ago|reply
[+] [-] whoisjuan|6 years ago|reply
It seems to me that rushing the timelines potentially opens up a lot of risks for post-vaccine side effects. Doesn't it?
[+] [-] technotony|6 years ago|reply
[+] [-] nokcha|6 years ago|reply
Depends what you mean by "need". If you're talking about a risk/benefit calculation for getting a vaccination, I expect it will play out very differently for high-risk elderly folks vs low-risk young adults.
[+] [-] deelowe|6 years ago|reply
[+] [-] guidedlight|6 years ago|reply
A small quantity of the virus could be introduced to your leg where it is away from your lungs and bloodstream. Your body could fight the virus there.
[+] [-] vikramkr|6 years ago|reply
[+] [-] danieltillett|6 years ago|reply
[+] [-] unionpivo|6 years ago|reply
Live ones, that are exactly like you said, low infectious strain, and dead ones, where they kill the virus and it sometimes still produces correct antibodies.
there are several of such types of vaccines in development
[+] [-] Leary|6 years ago|reply
[+] [-] phyrex|6 years ago|reply
[+] [-] 3fe9a03ccd14ca5|6 years ago|reply
Yeah that’s frightening, but really true? I’ve never heard of a single person dying from the flu vaccine locally.
[+] [-] yread|6 years ago|reply
[+] [-] jobseeker990|6 years ago|reply
[+] [-] unknown|6 years ago|reply
[deleted]
[+] [-] sjg007|6 years ago|reply
[+] [-] 12elephant|6 years ago|reply
As soon as isolation is lifted, whether that be in a month or 10 years, the spread will resume. Unless of course either a) herd immunity is developed or b) a vaccine is developed.
We've only ever eradicated one infectious disease in all of human history (smallpox) and we had a vaccine for that. See: https://www.historyofvaccines.org/index.php/content/articles...
[+] [-] LyndsySimon|6 years ago|reply
One thing I didn't see mentioned was a recent article that caught my attention - apparently, tobacco may be used as means of production for a potential vaccine [0].
Given that the linked article was published on April 1, I initially thought it to be satire. Upon further consideration, though, it not only seems to be genuine but it makes sense: tobacco is likely one of the best understood plants from a genetic standpoint, with a long history of successful genetic modification using both traditional and modern approaches. It's certainly one of the best understood that also has large-scale production capabilities, and I would imagine that the tobacco industry has more incentive than most to seek the positive PR that this could bring.
Finally, setting aside the greater political context, it seems to me that the FDA under the Trump administration is more flexible and risk-tolerant than any point in my lifetime (and perhaps in living memory). There are certainly many challenges that will have to be overcome before we get to the point that we're able to widely roll out an effective vaccine, but I strongly suspect that this flexibility will result in a speed of development and approval that will surprise many of us. Of course, that speed will come with associated risks, but that's just the nature of things.
I would not be surprised to see widespread voluntary human testing of promising vaccine candidates in the next six months - perhaps even sooner if a promising candidate ends up being derived from the past few years' work in creating a vaccine for SARS-CoV-1.
0: https://www.dailymail.co.uk/news/article-8175855/BAT-claims-...
[+] [-] avgDev|6 years ago|reply
I just want to offer a perspective of why this is dangerous. We are having some serious issues with flouroquinolone antibiotics. The side-effects of the medication are insane and under-reported. 9 years ago I was given the antibiotic for an infection, my body went into shock, I was released the next day with some odd neurological issues. None of it reported to the FDA, few months later I got tendon pain. I go to mayo clinic, they disagree the antibiotic caused it. Seen 30+ physicians in the span of 2 years, 2 agreed that it is possible. One of them said to wait it out, and refused to actually put it in my chart. The antibiotics carry a 'black label' and clearly state side effects may occur up to 1 year. I reported it to the FDA, then I found groups of people suffering from chronic fatigue, tendon raptures, weird neurological symptoms, some had diagnosis of 'fibromyalgia', some had chronic tendinitis, yet after reviewing their medical information they found they took a flouroquinolone antibiotic but nobody ever even suggested that it could be that.
This bring me to Tamiflu fiasco. Governments have spent billions of dollars to purchase Tamiflu to fight the flu. Later reports came out about issues with the studies, the maker picking positive studies and withholding neutral or negative information. It has not proven much better than the drugs we already use to treat the flu.
Fast tracking a medication can have terrible results, cost billions of dollars, and cripple hundreds of people. Doing any scientific research with panic in the back of your mind and high pressure from politicians and people is dangerous IMO. Especially, in a profit driven healthcare system.