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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

#81

Post by [deleted] »

takeda wrote: post #61
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 heard somewhere that we should be prepared for middle of next year. They don't want politics to influence the safety of it. Releasing a vaccine that would cause damage would be devastating for the company. I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them?

[deleted]

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

#82

Post by [deleted] »

warent wrote: post #52

I've recently heard an argument that the probability of being injured/killed by a vaccine (e.g. due to complications, allergies, etc.) is on average greater than the probability of covid causing damage/fatality to an individual, therefore if people are administered these vaccines then we'll actually see an increase in mortality/illness. Can anyone speak to this? I'm not sure how legitimate this is, but it sounds some…

[deleted]

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

#83

Post by rodonn »

warent wrote: post #52

I've recently heard an argument that the probability of being injured/killed by a vaccine (e.g. due to complications, allergies, etc.) is on average greater than the probability of covid causing damage/fatality to an individual, therefore if people are administered these vaccines then we'll actually see an increase in mortality/illness. Can anyone speak to this? I'm not sure how legitimate this is, but it sounds some…

Somewhere around 0.5-1% of people who are infected with COVID die and a larger share experience very serious symptoms, some of which can be long lasting/permanent. The risks for the elderly are even higher, something like 15% death rate for people older than 80.

In comparison the risks of a vaccine are much much much smaller, as long as the risks are similar to existing approved vaccines. The testing process is explicitly designed to make sure that no vaccine gets released that causes more harm than good.

For comparison here is the symptom sheet for the flu vaccine https://www.who.int/vaccine_safety/initiative/tools/vaccinfo... Or an easier to read summary https://immunizebc.ca/side-effects The risks of serious complications for flu vaccine are closer to 1 in 100,000 or 1 in 1 million, and even then the effects are usually much less serious than death.

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

#84

Post by DoreenMichele »

shajznnckfke wrote: post #37
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.

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…

with so many people out of work and struggling

This concern can be addressed other ways. I run two subreddits aimed at helping people establish an online income (as part of the goal).

In a post-covid world, I think we will do more good if we focus more on adapting to a new reality where increased germ control is a permanent expectation rather than expecting a vaccine to fix everything and allow us to return to "business as usual."

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

#85

Post by BurningFrog »

astrophysician wrote: post #9

Question: is it not a standard procedure to stop a Phase III trial early when the statistics warrant it? Isn't this a pretty cut-and-dried statistical question? Naively I would think that there's nothing controversial about ending a trial early, isn't that the ethical thing to do? I guess the political maneuvering angle before the election complicates all of that, but if the Trump administration is really willing to…

Vaccines are a bit different than "cures" for stopping trials.

If you test drug XYZ and after a while it's clear that far more people in the control group die, you quickly declare XYZ proven effective, stop the trial, and give XYZ to the control group to save as many lives as possible.

For vaccines there are no such dramatic effects. Everyone in the study is healthy, at least to begin with, so there is no tragedy to avert, and you can let the study keep going even after it starts becoming clear that the vaccine is good.

At least in theory. I don't know the actual bureaucratic protocols.

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

#86

Post by dmoy »

takeda wrote: post #61
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 heard somewhere that we should be prepared for middle of next year. They don't want politics to influence the safety of it. Releasing a vaccine that would cause damage would be devastating for the company. I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them?

> I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them?

Obviously no

They get a large set of people (tens of thousands), half placebo, and then check rates afterwards.

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

#87

Post by maxerickson »

credit_guy wrote: post #56

The actual pledge is here [1]. There are 4 bullet points, 3 of them are quite generic; the one that made all the waves is: "[we pledge to] Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA." I feel there's some weasel wording going on here. The…

'after demonstrating safety and efficacy' is not weasel wording though, it's just a different benchmark than 'completing the study'.

The headline is inaccurate, but that's on Statnews.

When studies go really well, doctors consider themselves ethically obligated to end them early, so that the placebo group can receive the treatment. That these studies have planned end dates well into the future doesn't mean that they must run that long (or that it will take that long to collect sufficient safety data).

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

#88

Post by Tarq0n »

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.

They probably could get some countries to indemnify them, they'd probably survive the damage to their reputation.

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

#89

Post by marcosdumay »

shajznnckfke wrote: post #37
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.

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…

A bad vaccine is pretty bad, and can easily be much worse than the virus. That's why we test them.

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

#90

Post by newacct583 »

airza wrote: post #55
warent wrote: post #52

I've recently heard an argument that the probability of being injured/killed by a vaccine (e.g. due to complications, allergies, etc.) is on average greater than the probability of covid causing damage/fatality to an individual, therefore if people are administered these vaccines then we'll actually see an increase in mortality/illness. Can anyone speak to this? I'm not sure how legitimate this is, but it sounds some…

I think ruling that out is the point of a phase 3 trial.

Exactly. Realistically vaccines are very safe, very occasionally they aren't. So you start small and increase the sample size gradually to manage that risk until you have enough data to show both efficacy and safety.

To be fair: it's also a global pandemic, and one very poorly controlled in the US. So there is real and quantifiable risk to being "too slow", also. Balancing between the two extremes isn't well-served by a static protocol, you'd do something different for a vaccine against ebola (where you want to take your time because there are very few cases) than you would for covid (more urgent, low thousands of people dying every day) than you would have in the 50's for polio (an ongoing global catastrophe).

So... sure. It's not at all unreasonable that an "emergency" vaccine approval might happen. Which is why it's such a disaster that the FDA has given the appearance of being politicized (c.f. the plasma nonsense announcement, the right wing journalist hired as a press manager by the white house and then fired from within the bureaucracy). There is real concern that this administration really would "cheat" with a vaccine announcement in a way unsupported by the science.

So now worry about blowback is forcing the pharma companies to, perhaps, err in the opposite direction by ruling out an emergency approval. I'm not sure that's right either.

(Or maybe they all know there's no way they'll have valid data before November and are just trying to shut the debate down early.)

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