Covid vaccine makers commit to not seek approval until complete Phase III trials • Hacker News Board

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

#91

Post by MacsHeadroom » Tue, Sep 08, 2020, 7:52 PM UTC

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?

Vaccines shouldn't be rushed because that's how you kill people with vaccines. Phase 3 vaccine trials take 18-24 months for very good reasons.

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

#92

Post by shajznnckfke » Tue, Sep 08, 2020, 7:52 PM UTC

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.

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.

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

#93

Post by apocalyptic0n3 » Tue, Sep 08, 2020, 7:52 PM UTC

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?

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.

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

#94

Post by loeg » Tue, Sep 08, 2020, 7:52 PM UTC

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?

No, and this is why Phase III trials take a long time, potentially a very long time if we actually get a handle on the virus with measures like masking and social distancing.

Here's the protocol:

1. Volunteers get the vaccine (experimental arm) or a placebo (control arm).

2. They go about their lives.

3. Both study arms report any cases of COVID they develop. Also, any deleterious symptom (potential side effects).

4. If the vaccine arm has a statistically significant reduction in infection rates, and/or severity, everyone wins and the study is concluded.

This process can take years if the background rate of infection is low enough.

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

#95

Post by gilbetron » Tue, Sep 08, 2020, 7:53 PM UTC

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…

"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".

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

#96

Post by blumomo » Tue, Sep 08, 2020, 7:53 PM UTC

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.

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

#97

Post by Dylan16807 » Tue, Sep 08, 2020, 7:53 PM UTC

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?

I feel like ending the pandemic is not a motivation that is likely to make a researcher (an expert) rush things and end up hurting more people. Greed or glory is much more likely to be a motivator for that kind of mistake.

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

#98

Post by Amygaz » Tue, Sep 08, 2020, 7:54 PM UTC

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…

Quote:[I've recently heard an argument that the probability of being injured/killed by a vaccine (e.g. due to complications, allergies, etc] is extremely remote...

See? I just fixed it!

Oh wait! You’re just trolling aren’t you?

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

#99

Post by FreakyT » Tue, Sep 08, 2020, 7:54 PM UTC

shajznnckfke wrote: post #59

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.

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/

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

#100

Post by Vysero » Tue, Sep 08, 2020, 7:54 PM UTC

hackyhacky wrote: post #10

Vysero wrote: post #3

"Sen. Kamala Harris of California, the Democratic vice presidential nominee, hinted that she would not take a Covid-19 vaccine if one were approved and distributed before the election. “I would not trust Donald Trump,” she said in a CNN interview. “I will not take his word for it.”" Tell me again why I should care what Kamala Harris opinion on the matter is? It must be her infinite knowledge and experience as a train…

Her opinion seems to echo that of 82% of Democrats and 72% of Republicans, who express concern that the timeline for the vaccine may be influenced by political concerns rather than healthcare best practices. Given the the messaging from the current administration, those concerns are entirely reasonable.

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.