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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

#101
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.

Well, this is a case of high risks and high rewards. I don't know a lot about business, but I don't find it hard to imagine that there's some companies out there that are willing to take the risk, especially if they have some kind of government agreement that can alleviate their liability.

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

#102
post #61
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?

No one will be told to go intentionally infect themselves. There will be no human virus challenge trials in the US as that would obviously never pass a review board. Instead they will vaccinate a study group and then compare infections, symptoms, and deaths versus a control group.

The best estimate of infection fatality rate is 0.65%, not 1%.

https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scena...

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

#103
What exactly is this news source doing here? Just repackaging a press release? There are very important questions being asked here about the wording. Journalists should be the one thinking up these questions and asking them. They shouldn't publish these kinds of statements without doing this. Otherwise they are no more than propaganda machines.

Fake news is not only out-right lying, it's journalists not doing their jobs of asking the hard questions.

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

#104

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…

The usual protocols have been well and truly thrown out the window, so I don't know what the comparison point would be. Moderna didn't even finish animal trials before giving their vaccine to humans.

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

#105
post #76

Earlier quoted context omitted.

>> 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.

especially right now, a failure when so many are paying attention (and large part of population is now anti-vaxers) could actually ruin the company.

should have added that that the vaccine has very limited $$ potential (can't charge a gazillion for it due to bad PR and competition) and most makers have hundred billion brands that can be ruined by this. So they aren't going to risk their company for this. Lastly, suppose Acme Pharma released it against all common sense, all over the media scientists would talk against it, so lose-lose.

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

#106
post #86
post #61

Earlier quoted context omitted.

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.

The larger the set the faster the results, but a large set is expensive. "Afterwards" is sort of a simplification. The study arms are compared regularly throughout in case the study needs to be ended one way or the other (Data and Safety Monitoring Committee). (If the vaccine is effective: great, we want to ramp up production and give it to everyone ASAP. If the vaccine is ineffective or has very bad side effects, we also want to conclude the study.)

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

#107
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.

The U.S. has a similar regulatory regime to manage vaccine liability. But it's not a free-for-all; vaccines need to meet certain criteria before they qualify for this program.

This is a huge reason that these companies are concerned. If they are pushed to release a vaccine too early, and it harms a bunch of people, any evidence they bent the rules at all will be used to try to break their immunity from civil liability. It would be a field day for personal injury lawyers.

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

#108
The vaccine hail Mary is weird to me. We've seen that herd immunity can be achieved (see Sweden). People under 65 with sufficient levels of vitamin D have extremely low odds of dying from this disease, less than even the flu. The CDC reported that less than 10% of deaths reported were from Covid alone. We're probably already near herd immunity with hospitalizations plummeting everywhere. Why are we still pinning everything on hopes for a vaccine?

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

#109
WTF. This is going to kill people. A lot of people.

Look, the usual situation with vaccines is that we are weighing (1) the danger posed to the few people who get sick while the trials are going on; vs. (2) the risks taken on by everybody who gets the vaccine. The vaccine might have a small likelihood of triggering reactions or otherwise having adverse effects, and spread over the entire population these edge cases can add up to do more damage than the disease itself.

Again, that is for typical vaccine situations. A pandemic is totally different--the number of cases is exponentially increasing and ripping through the entire population. So our options are:

1. Wait the additional 6-12 months it would take (even accounting for the immense investments that have been made) to get a vaccine to go through all the normal regulatory hoops we would demand of vaccine development outside of a pandemic. During which time COVID-19 rips through the population leaving potentially millions dead and hundreds of millions of recovered with disease-related tissue damage.

2. Wait, but stay in lockdown to keep the disease at bay, but in the process massively drive up suicide, domestic violence, and divorce rates, wreck the economy, and force people to spend their savings and/or trigger massive inflation through pandemic relief.

3. Some horrible compromise between the above two extremes.

4. Roll out the vaccines as quickly as they can be manufactured, starting now. Don't wait for Phase III results.

The Phase I and Phase II trials tell us that the vaccine successfully generates antibodies. The group sizes so far have been large enough to know that the risk of fatal interactions is less than the risk of dying from COVID-19 itself--indeed, for the most part there haven't been ANY severe reactions, at least in the major vaccines.

This "wait until the vaccine is proven safe!" is politically generated nonsense. There is no data-driven argument supporting it. Ideologues on the left assume that Trump wants a vaccine ASAP to win reelection, don't trust is understanding of the science, and therefore assume that early administration of a vaccine would be some sort of unsafe political compromise. Ideologues on the right believe COVID-19 is a hoax anyway. But even a broken clock is right twice a day, and the fact that Trump wants a quick vaccine approval has no bearing on whether it is a good idea or not; and in this case it very clearly IS beneficial to distribute a vaccine as quickly as it can be manufactured.

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

#110
post #99

Earlier quoted context omitted.

We already know that some of the vaccine candidates work (ie. immune response). I’m not arguing we should ship untested vaccines, but challenging how many months we need to wait after testing.

We know that they trigger an immune response, but that alone doesn't necessarily mean much. For example, an early SARS vaccine candidate triggered an immune response in tests, but that immune response in practice actually made SARS infections worse .[1] [1]: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3335060/

Yeah, certainly we ought to see how animals and people with the vaccine react when exposed to the virus, but have we not already done that in the months these vaccine candidates have been tested? The current trials did things like give the vaccine to thousands of Brazilian health-care workers, which should have uncovered any issues like that (in the article you linked, the issue was uncovered by testing in a small sample of animals).
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