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Vaccine hopes rise as Oxford jab prompts immune response among old and young

reuters.com

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Re: Vaccine hopes rise as Oxford jab prompts immune response among old and young

#421

Post by GekkePrutser »

eternalban wrote: post #351
eumenides1 wrote: post #170

Earlier quoted context omitted.

The point is that we should reconsider giving (temporary) monopolies to companies that are based public research. I suggest that we should give merek the for profit monopoly, but allow for non profit manufacturing. If another organization wants to make the vaccine but not derive profit from the process, let them. Manufacturing takes time and money to develop. Revenue should pay for those costs. The non-profit gains e…

Society at large is being asked to make drastic adjustments because of a collective health issue. Why is the corporate "right to make profit" sacrosanct when nothing else is? This is a clear case of Eminent Domain. All mandated, mandatory, Covid-19 related products must be offered at cost, or even better, we should just nationalize drug companies. We're all in this together and companies need to adjust to "new normal…

Totally agree. This is not the time for bean counters. We need to fix this and we need to do it now.

Re: Vaccine hopes rise as Oxford jab prompts immune response among old and young

#422

Post by mithr »

cookingrobot wrote: post #402
EpicEng wrote: post #391

Earlier quoted context omitted.

>But for this disease that's particularly bad because... Doesn't change the fact that, when you're developing a new drug, you want to test it in a way which will cause the least harm. You don't begin trials with those most at risk for obvious reasons. The primary goal of this phase it to asses the safety of the vaccine candidate. I'm also unaware of any disease that isn't more threatening to people in relatively poor…

You say it’s “obvious” but it’s the opposite of my intuition. Can you explain the logic a bit more? I would have thought you’d give a risky new drug to the least healthy, most likely to die without it population, to raise the chance of survival from low to unknown.

There are a few factors -- one is that the major goal is to measure the side effects and safety of a particular new drug, in relative isolation... someone who is already sick is more likely to be on other drugs, thereby greatly increasing the risk of drug interactions.

Another is that when someone is already sick, they are more likely to not do well with any particular new drug (pretty much nothing is 100% effective for 100% of people), so you'd have to have some way to trying to discern whether the fact they got worse or even died is related to the new drug vs. just a natural progression. This can get complicated to measure.

And specifically for this particular thread, this is a vaccine, not a cure -- so in any case, when we say "least healthy" in this context, we're not talking about giving it to people who are already diagnosed with the virus, but rather to those who are _at most risk of complications_ from the virus, _if they were to contact it_. So it would be giving a drug to people who _don't_ immediately "need" it to survive, but who are still most at risk from any side effects.

Re: Vaccine hopes rise as Oxford jab prompts immune response among old and young

#423

Post by keyme »

cwhiz wrote: post #418

Can someone explain to me why double blind is necessary or useful for a vaccine trial such as this? It seems obvious to me on something like a pain medicine, but on a vaccine it seem a pointless. Is placebo an actual issue with a vaccine? It honestly seems borderline unethical to give people a placebo vaccine.

Placebo can have an effect on side effects.

Re: Vaccine hopes rise as Oxford jab prompts immune response among old and young

#424

Post by ska »

SN76477 wrote: post #364
fcsp wrote: post #349

Earlier quoted context omitted.

Considering all the excluded groups on the trial (page 3, kids, 55+, obese, weak immune system, a lot more), it's a lot of exclusions, how does one get from results on a study like this to declaring the vaccine safe for general use?

"The purpose of this study is to text a new vaccine against COVID-19 in healthy volunteers. So I am assuming this is the control group.

The control group will not be given the vaccine, but a placebo.

Clinical trials are phased. Typically you start with a very small group of people to evaluate toxicity (e.g. below treatment levels of a drug), then a slightly larger group looking for side effect, then a significantly larger group looking for desired effects, and finally a broad group looking for safety and efficacy.

Re: Vaccine hopes rise as Oxford jab prompts immune response among old and young

#425

Post by kbutler »

cookingrobot wrote: post #402
EpicEng wrote: post #391

Earlier quoted context omitted.

>But for this disease that's particularly bad because... Doesn't change the fact that, when you're developing a new drug, you want to test it in a way which will cause the least harm. You don't begin trials with those most at risk for obvious reasons. The primary goal of this phase it to asses the safety of the vaccine candidate. I'm also unaware of any disease that isn't more threatening to people in relatively poor…

You say it’s “obvious” but it’s the opposite of my intuition. Can you explain the logic a bit more? I would have thought you’d give a risky new drug to the least healthy, most likely to die without it population, to raise the chance of survival from low to unknown.

The high-risk population introduces statistical complications evaluating the results - were bad outcomes caused by the treatment under investigation or by the preexisting conditions?

Re: Vaccine hopes rise as Oxford jab prompts immune response among old and young

#426

Post by blackbear_ »

sanketskasar wrote: post #42
godelmachine wrote: post #16

Is this not the one they will launch in India first? Edit1: Just to throw in more info, Oxford plans to scale this up for mass production with Serum Institute of India and AstraZeneca.

It is the same. But you cannot expect a vaccine to work similarly in people of two different regions having major differences in their diet, climate and lifestyles. That's why many vaccine candidates are being tested in multiple countries( read potential markets). Also, I think the UK has preferential rights at least on the initial yield of the vaccine.

This is very true and undeserving of the downvotes. A vaccine can work globally, but it is not at all guaranteed.

This is because the distribution of certain alleles, fundamental for the immune system, is heavily biased geographically [1].

[1]: http://pypop.org/popdata/

Re: Vaccine hopes rise as Oxford jab prompts immune response among old and young

#427

Post by Domenic_S »

tarboreus wrote: post #330
krustyburger wrote: post #311

Earlier quoted context omitted.

Drug companies also fund their own research, to the tune of massive expenditures. What you’re suggesting would incentive these companies to disengage from partnerships involving public funding. Whoever pays for the research, each company’s goal is to profitably sell a non-generic treatment. If the only way they can do that is to eschew public funds, they will do this and the result will be less cooperation and a far…

Honestly, this is overblown. Most of the budget for these corporations goes to marketing, and the R&D mostly goes to repatenting efforts or incremental repurposings. They rarely come out with anything new, and if you look at recent years you may as well say that they never do.

The FDA has made 42 new drug approvals in 2020: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-...

Certainly some of those are new uses for existing drugs, but drug trials ain't cheap either.

Re: Vaccine hopes rise as Oxford jab prompts immune response among old and young

#428

Post by cwhiz »

keyme wrote: post #423
cwhiz wrote: post #418

Can someone explain to me why double blind is necessary or useful for a vaccine trial such as this? It seems obvious to me on something like a pain medicine, but on a vaccine it seem a pointless. Is placebo an actual issue with a vaccine? It honestly seems borderline unethical to give people a placebo vaccine.

Placebo can have an effect on side effects.

Are they testing for side effects in all three stages? I thought the first two trials were for safety and the third was for efficacy. Is that incorrect?

Re: Vaccine hopes rise as Oxford jab prompts immune response among old and young

#429

Post by koboll »

cwhiz wrote: post #418

Can someone explain to me why double blind is necessary or useful for a vaccine trial such as this? It seems obvious to me on something like a pain medicine, but on a vaccine it seem a pointless. Is placebo an actual issue with a vaccine? It honestly seems borderline unethical to give people a placebo vaccine.

You're right, and researchers are aware of this:

https://www.statnews.com/2020/09/03/placebos-arent-needed-ch...

Also, there is a very strong risk, given the global situation, that the longer placebo-controlled trials go on, the less reliable the data will be, because control-group subjects will ignore the rules of the study and go get vaccinated as soon as it's broadly available just in case. So even just looking at data quality and excluding other considerations, placebos have major risks that probably outweigh the benefits of administering them for months or years like a usual vaccine trial would.

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