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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

#161

Post by rsynnott »

garmaine wrote: post #120
apocalyptic0n3 wrote: post #93

Earlier quoted context omitted.

The bigger issue is if they rush a drug that does long term harm to people, it could destroy the company. This is a drug that they will be giving out to 300+ million people in the US along. Screwing it up would result in a massive amounts of lawsuits that they may not recover from. They don't want to risk that just for some political capital with a person who may not be in power in a few months.

The fix for that is easy: have the FDA authorization grant them immunity from vaccine safety or efficacy liability.

Reputational damage would be a greater risk; this could quite easily turn into the greatest pharmaceutical scandal in history.

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

#162

Post by triceratops »

blackflame7000 wrote: post #73
Tepix wrote: post #20

Earlier quoted context omitted.

Why do people care about what medical advice Trump has to offer? We don't really need a vaccine, we can just drink bleach!

I think Trump’s sarcasm is lost on some people and thats why they dislike him so passionately.

Maybe he should stop using sarcasm then. Being a good communicator is part of his job.

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

#163

Post by maxerickson »

nfw2 wrote: post #151

After hearing Fauci's recent comments on the matter, my understanding is that the phase III trials can be considered for approval once there are enough infections in the control group to do a comparative analysis. Since the events now needed to confirm the vaccine are in the control group, not the experimental group, it seems that the blocker for approval now isn't SAFETY, as it has been continually suggested, but EF…

No, phase III is still examining safety.

For example, they document how a larger number of vaccinated individuals react to infection. A phase II trial might not track any infections.

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

#164

Post by gniv »

SpicyLemonZest wrote: post #70
JMTQp8lwXL wrote: post #46

Earlier quoted context omitted.

No point shipping a vaccine early if it doesn't actually work. That could do more damage, people thinking it's safe to be around others maskless, when in fact the world population instead received an ineffective vaccine.

I think you're misunderstanding the problem space here. We don't expect a coronavirus vaccine to prevent close to 100% of infections, so it's not a binary question of working vs. not working. The question is, how strong of an effect at what level of confidence is required to conclude that it's working well enough?

> We don't expect a coronavirus vaccine to prevent close to 100% of infections

Why not? I would have thought we do. Most vaccines do (flu notwithstanding).

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

#165

Post by newacct583 »

treeman79 wrote: post #38
ars wrote: post #2

"82% of Democrats and 72% of Republicans expressed concern that the Covid-19 vaccine approval process would be driven more by politics than by science. More than 80% of independents, Republicans, and Democrats said they would worry about the safety of a vaccine that was approved quickly." Wow. And lest you think this is a Trump thing, the figures are similar in European countries. A bad COVID vaccine (one that doesn'…

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…

What you just described is a "policy" decision, one designed to optimize for good results. A "political" decision would be one designed to increase one's support among some sort of collective-decision-making class (voters, in this context). It's sort of the opposite, in context.

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

#166

Post by Vysero »

ciarannolan wrote: post #150
Vysero wrote: post #100

Earlier quoted context omitted.

Okay, and that's fine, but why her? Why not quote some virologist or someone who isn't.. oh I don't know, currently running as vice president in the upcoming election? At best the author is making the same mistake being talked about in the article by accident. At worst they are quoting her because they support her bid in the upcoming election. Either way it's politically biased.

> Okay, and that's fine, but why her? > [...] currently running as vice president in the upcoming election? You're almost all the way there to answering your own question.

Your serious? Her being a politician should EXCLUDE her opinion on the mater as completely irrelevant... she is not an expert and therefore her opinion is as relevant as Trump's = irrelevant!!! Wake up!

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

#167

Post by noodlenotes »

chrisco255 wrote: post #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 ever…

The problem is that the people who back reopening are also against precautions that would make reopening safer. If I could trust the random people I'll encounter to wear their masks correctly and stay home if they're sick, maybe I would feel safe going out again. But instead politics has emboldened these people to behave in ways that put the people around them at more risk than necessary.

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

#168

Post by DenisM »

ConsiderCrying wrote: post #58
jwieczorek wrote: post #15

Meanwhile, Russia just today announced it is starting the release of the first batch of its own vaccine to the public. https://www.aljazeera.com/news/2020/08/sputnik-russia-corona...

Not sure why this got downvoted, it's not like the person is endorsing Russia's decision. I'm highly skeptical a country that refused to go on lockdown and underreported cases would make a safe vaccine faster than the rest of the world.

> country that refused to go on lockdown

What? Moscow lockdowns were some of the harshest outside East Asia.

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

#169

Post by DoreenMichele »

shajznnckfke wrote: post #156
DoreenMichele wrote: post #84

Earlier quoted context omitted.

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 "busin…

I do think there will be a permanent adjustment in society to deal with the risks created by this type of virus in the future. Tell everyone to start wearing masks as soon as the outbreak starts, instead of telling them that masks are only for idiots and healthcare workers. Isolate travelers from affected areas before it has a chance to spread, and so on. But I also expect that just about every occupation from indust…

Well, I didn't say anything about eliminating jobs. Just that I, personally, see no reason to tie the idea of going back to work to a vaccine.

I think we would do better to look for germ control solutions that are already proven and available currently. As one example, ordering online or calling ahead and picking up is a way to support local eateries while minimizing the spread of germs. I'm a big fan of Little Caesar's pizza portal as a contactless pick-up option and I don't see any reason we can't actively promote such existing practices right here, right now, instead of seemingly hanging all hopes on "there will be a vaccine and after it comes out, we can just keep doing the same things the same way."

That seems like needless suffering to me. We don't know how long that will take and, in the mean time, people need to survive right now. Not having any money/resources at all coming in for X months is not survivable for most people who don't have savings and the like to live off of.

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

#170

Post by talentedcoin »

DoreenMichele wrote: post #84
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…

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 "busin…

I think this comment is correct and is something that is being missed in the present conversation. For those who disagree -- isn't it better to take realistic steps to help people instead of just crossing our fingers and waiting for a vaccine?
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