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Covid vaccine makers commit to not seek approval until complete Phase III trials

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Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#131

Post by unethical_ban »

calvinmorrison wrote: post #65
dmarchand90 wrote: post #36

Earlier quoted context omitted.

My impression is that this was done to specifically counter Donald Trump rushing a vaccine prior to the election. I don't think it was really made to give any security beyond that

How about "rushing" the vaccine to you know... end the pandemic? Or would you rather more people die "from covid" to hurt Trumps chances of winning?

Let me clarify what I think the parent meant.

This announcement was made very shortly after Trump started making claims that a vaccine could be ready "late October/early November". Trump is a known fool, and even were he not, his losing prospects at re-election, combined with the criticism of his administration's response to the pandemic make it seem like he could be pushing vaccine makers to rush a treatment to pump up voter support.

I believe vaccine makers are diplomatically responding to the Trump headline by saying "We aren't going to rush this for the wrong reasons."

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#132

Post by bglusman »

So, correct me if I'm wrong, but

a) current hypothesis is people with prior exposure to common-cold non-COVID-19 coronaviruses are by and large either asymptomatic or have milder symptoms than those without such exposure

b) presumably it should be possible to test people for these antibodies much as we can test people for COVID antibodies

If people would volunteer for the b) anti-body test in reasonable numbers, and a subset of them who have them would volunteer for a modified trial, we could possibly do a double-blind intentional-exposure test on people to confirm that the vaccine confers BETTER immunity than the existing similar antibodies do, right? Would it be possible to ethically and realistically use that strategy to accelerate effectiveness testing (if not safety testing) of any vaccine candidates? or would the smaller scale of that have only made sense for something more like Phase 2 trials?

Arguably, as long as safety is near perfect, we should be willing to tolerate only moderate (say, 90%) effectiveness (and I'd read one of the vaccines took two doses to get 100% effectiveness but was 90% after a single dose), but I don't know how safety is evaluated and obviously long-term safety and short-term safety are pretty different/I imagine a lot of people will be more concerned about long term safety and I don't know how you can reassure them on that on any kind of accelerated schedule.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#133

Post by landryraccoon »

Vysero wrote: post #117
hn_throwaway_99 wrote: post #78

Earlier quoted context omitted.

Such a bizarre argument. Direct quote from your comment: > Tell me again why I should care what Kamala Harris opinion on the matter is? Literally no one else is telling you that you should care what Kamala Harris' opinion on the matter is. You are the only one that seems to care what her opinion on the matter is.

By including the quote from a political candidate the author is saying (without words) that her opinion on the mater matters. Therefore, the AUTHOR is telling me that I should care what Kamala Harris' opinion on the matter is. How can you not see that?

I understand your position, but I don't see why this is cause for getting worked up.

After 9/11, the media famously asked rapper Ja Rule what he thought of the terrorist attacks. Obviously he wasn't an expert in international relations or counterinsurgency tactics. If it offends you that the media ask celebrities and well known individuals what their opinion is, then I scarcely can imagine any mass media channel that won't raise your blood pressure.

I'd just ignore it and move on. Media wants clicks, it is what it is.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#134

Post by CodesInChaos »

gilbetron wrote: post #95
treeman79 wrote: post #38

Earlier quoted context omitted.

It is a political decision. The kind leaders are supposed to make, the kind they don’t like making. A leader has to decide on either pushing early and either saving/condemning hundreds of thousand of lives. Or playing it safe and condemning/saving hundreds of thousands to death while we complete years worth of trials. Oh because that’s not enough pressure the economy is burning, which will cost many lives as well. It…

"political decision" in this context is making a decision to approve something to increase the odds of one candidate winning. It is not "a decision by a politician" but rather "a decision with the primary motivation being political gains only".

Are you sure the polled people interpreted it like that?

I for one read it as politicians pushing for a quick release because the effects of the pandemic are so bad while the risk of side-effects is difficult to predict.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#135

Post by lettergram »

liability wrote: post #60
lettergram wrote: post #48

Earlier quoted context omitted.

> The FDA has already said that 50% effectiveness would be sufficient, which would put it about on par with the seasonal flu vaccine. I think it’s difficult to quantify how successful the flu vaccine is. I’ve reviewed the numbers and it’s not clear the general flu vaccine does anything. That being said, targeting specific strains can help (problem with flu is the various strains and ability to mutate so easily).

They make a new flu vaccine twice a year and effectiveness is quantified each time. https://www.cdc.gov/flu/vaccines-work/past-seasons-estimates...

The problem is correlations. The flu naturally varies in severity by region, age, time, etc.

Even the studies you linked, anything prior to 2010 is suspect by participant counts being way too low. More recent studies appear better, BUT we don’t have anything prior to when vaccines started to compare.

I’m not saying the evidence isn’t there, I am arguing it’s circumstantial - aka not definitive how much it helps. Flu itself varies in severity widely.

I’m honestly convinced the entire flu vaccine program / push is to keep the industry active. This is similar to the DOD spending money on new weapons they don’t need to keep manufacturing going

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#136

Post by BurningFrog »

spamizbad wrote: post #71
shajznnckfke wrote: post #37

Earlier quoted context omitted.

The virus is pretty bad, right? Ought we be making a cost-benefit analysis where we compare the risks of side effects from the vaccine to the risks of the spread of the virus? In comparison to a vaccine like Gardisil, which surely prevents far fewer deaths than a covid-19 vaccine will, wouldn’t such an analysis actually indicate that the trials be rushed to some extent? I’m feeling anxious that the current political…

The 1976 swine flu outbreak is one example of what can go wrong if you rush a vaccine: https://en.wikipedia.org/wiki/1976_swine_flu_outbreak It was rushed by the Ford administration for political reasons and got a lot of people very sick.

Let's quantify "a lot of people".

Out of 45 million vaccinated, 450 got Guillain-Barré Syndrome. I couldn't find info on if any of them died.

That would have been acceptable if it had stopped a disaster, but as it turned out the 1976 Swine Flu epidemic never really materialized as expected.

With Covid killing 1000 Americans per day, I think we should happily accept those odds of side effects or worse.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#137

Post by DavidSJ »

bglusman wrote: post #132

So, correct me if I'm wrong, but a) current hypothesis is people with prior exposure to common-cold non-COVID-19 coronaviruses are by and large either asymptomatic or have milder symptoms than those without such exposure b) presumably it should be possible to test people for these antibodies much as we can test people for COVID antibodies If people would volunteer for the b) anti-body test in reasonable numbers, and…

What’s your source for (a)? I think virtually every human being on the planet has been infected with some coronavirus common cold strain in the past.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#138

Post by Jaepa »

onetimemanytime wrote: post #47
wearhere wrote: post #5

What’s the timeline for Phase III trials? The article doesn’t seem to say. I don’t feel reassured that those won’t be rushed.

>> I don’t feel reassured that those won’t be rushed. actually I am. Vaccine makers don't gain much by doing something risky (considering the negatives) so they'll check the ones seeking election at all costs.

Under normal times I would agree.

There is already employer liability protection in the Senate stimulus bill, I wouldn't be surprised to see some sort limited liability clause added for vaccine makers as well.

Also with only 38.9 approval rating of Trumps covid response, and him trailing in the polls I wouldn't be shocked to see him trying to pressure some sort of deliverable around the end of Oct, which is when some of the 3rd phase ends.

EDIT:

From Trump

> "We’re gonna have a vaccine very soon. Maybe even before a special date. You know what date I’m talking about."

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#139

Post by blumomo »

eCa wrote: post #122
blumomo wrote: post #96

Here in Europe they are freed from legal consequences should the vaccine harm someone. Instead our countries are to pay any occurring damaging. So I don’t quiet get what motivated the vaccine makers to await the approval given that they are practically free from prosecution anyway.

It should be in everyone's (and certainly the manufacturers') interest that the vaccines actually are safe.

Past has shown that it wasn’t. See swine flu vaccinations.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#140

Post by shajznnckfke »

timr wrote: post #123
shajznnckfke wrote: post #92

Earlier quoted context omitted.

Is this the worst-case scenario? It doesn’t sound nearly as bad as covid-19. My concern is that there’s an agency whose job is to minimize the risk of harm from a covid-19 vaccine, but not an agency whose job is to balance the risk of harm from a vaccine with the ongoing harm from not having a vaccine.

"Is this the worst-case scenario? It doesn’t sound nearly as bad as covid-19." This is a case where the media hysteria surrounding the risks of Covid isn't helping anyone. If polling is to be believed, the general public significantly overestimates their personal risk of mortality from the virus: https://us.beyondbullsandbears.com/2020/07/28/on-my-mind-the... As noted by the link above, the vast majority of that risk…

Maybe we should first distribute the vaccine to the elderly, then? It sounds like the trade-off benefits and risk would be different there.
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