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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

#51

Post by ip26 »

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…

I think the common understanding of a decision 'driven by politics instead of science' is making the choice in the way that most advantages your own political career, instead of the way that saves lives or the economy.

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

#52

Post by warent »

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 somewhat convincing enough to be concerning.

EDIT: Downvoting someone for asking questions, even if based on a false premise, is completely shameful, especially when there's no claim to fact and it's clearly not made to be inflammatory. This community should encourage asking questions. Think carefully before throwing around a downvote as a marker of disagreement.

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

#53

Post by Vysero »

meheleventyone wrote: post #28
Vysero wrote: post #18

Earlier quoted context omitted.

Really? Considering the article is talking about how these things could be politically motivated I find it pretty dang odd to then go on by quoting a politicians opinion on the mater...

You seem to be trying to say something but trail off into weak points all the time. Why would you not talk to the opposition about a politically motivated issue made by the President?

Funny.. the article doesn't seem to have any quotes from politicians supporting Trumps view point. Had there been one, I would have called it out as well, but their isn't.. is there?

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

#54

Post by eanzenberg »

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'…

Not sure how this is an ‘only’ Trump thing. Republicans believe D-politics will delay the vaccine so it doesn’t come out before Nov 3rd, and Democrats believe R-politics will prematurely release a vaccine before Nov 3rd.

This country has become so politically cancerous that I wonder if a WW2 style event were to happen (as if Covid isn’t one already) if the country could unite around it, today.

And before you question the thesis, I’ve had the pleasure of listening to a few doctors lament the possibility of having life-saving therapies or vaccines if it helped Trump get re-elected.

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

#55

Post by airza »

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.

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

#56

Post by credit_guy »

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. They don't pledge to ask for approval after the completion of Phase 3. Instead they use a very convoluted phrasing, that's designed to make people think it's after Phase 3 is completed, but if you read more closely says something quite different.

When is the Phase 3 for Moderna expected to be completed anyway? This is readily available information at clinicaltrials.gov [2]. The estimated study completion date is October 27, 2022. Is the CEO of Moderna saying he will not seek approval prior to that date?

Pfizer's estimated study completion date is November 14, 2022 [3].

Two years from now doesn't sound quite "warp speed" to me. Did they take billions of dollars of public money to deliver a vaccine in 2 years?

[1] https://www.businesswire.com/news/home/20200908005282/en/Bio...

[2] https://clinicaltrials.gov/ct2/show/NCT04470427

[3] https://clinicaltrials.gov/ct2/show/NCT04368728

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

#57

Post by gizmo686 »

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…

Covid isn't that bad when compared to the potential harm that a dangerous vaccine could cause when injected into billions of people. Particularly because deploying the vaccine would not immediately stop all the covid19 damage. Further, deploying a dangerous or innefective vaccine would also cause significant long term damage to public health by fueling doubt in healthcare; particuarly since antivaccers are already a growing public health concern.

If we want to rush the process safely, the way forward is a challenge trial; where we deliberatly expose vaccinated people to the virus to see if they get infected. If you cannot get that experiment passed an ethics review board, you should not be able to get widespread deployment of an untested vaccine passed.

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

#58

Post by ConsiderCrying »

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.

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

#59

Post by shajznnckfke »

JMTQp8lwXL wrote: post #46
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…

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.

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.

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

#60

Post by liability »

lettergram wrote: post #48
gizmo686 wrote: post #23

Earlier quoted context omitted.

It doesn't even have to be a "bad" vaccine. The FDA has already said that 50% effectiveness would be sufficient, which would put it about on par with the seasonal flu vaccine. Combined with a high baseline infection rate, and an aggressive testing regime (at least compared to flu/other non-pandemic diseases), there will be a lot of people who get vaccinated and proceed to get sick and test positive. The real evidence…

> 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...

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