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

#121

Post by takeda » Tue, Sep 08, 2020, 8:00 PM UTC

shajznnckfke wrote: post #75

gizmo686 wrote: post #57

Earlier quoted context omitted.

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…

Given the way this story is going, I’m somewhat expecting a future where right-wingers refuse to wear masks but happily take the vaccine, while the left goes antivax and refuses to take it (because it was “rushed by Trump”) but continues to wear masks. Perhaps by our powers combined, we’ll defeat the virus!

That's why they want to absolutely make sure it won't cause a damage. The vaccine in 1976 was rushed for political reasons and that didn't end up well besides hurting many people it is also still used as an argument why you should not vaccinate.

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

#122

Post by eCa » Tue, Sep 08, 2020, 8:00 PM UTC

blumomo wrote: 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.

It should be in everyone's (and certainly the manufacturers') interest that the vaccines actually are safe.

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

#123

Post by timr » Tue, Sep 08, 2020, 8:00 PM UTC

shajznnckfke wrote: post #92

spamizbad wrote: post #71

Earlier quoted context omitted.

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.

"Is this the worst-case scenario? It doesn’t sound nearly as bad as covid-19."

This is a case where the media hysteria surrounding the risks of Covid isn't helping anyone. If polling is to be believed, the general public significantly overestimates their personal risk of mortality from the virus:

https://us.beyondbullsandbears.com/2020/07/28/on-my-mind-the...

As noted by the link above, the vast majority of that risk is concentrated in the oldest/sickest people. If everyone in the population is given a vaccine with even a fraction of a percent mortality, it could vastly exceed the risk posed by the virus to younger people.

It would be tragic, for example, to see any serious side-effects from a vaccine in people under the age of 20, who have essentially no risk from infection.

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

#124

Post by vikramkr » Tue, Sep 08, 2020, 8:00 PM UTC

astrophysician wrote: post #43

vikramkr wrote: post #26

Earlier quoted context omitted.

If the statistics warrant it then yes, but for a vaccine, even waiting to finish these trials is an incredibly rushed schedule. This isn't even about stopping the trial early - this is about approving it conditionally before the trial is done and then waiting for the trial to end to really approve it. I don't think the concern is about fabricating phase III data. The concern is that extreme political pressures mean n…

> This isn't even about stopping the trial early - this is about approving it conditionally before the trial is done and then waiting for the trial to end to really approve it I see -- yea totally agree, I thought they were committing to a rigid timetable or something but that's not what's happening here as you say.

Yeah - its some unprecedented stuff for a vaccibe. One important thing to remember is that its impossible to test two important factors for vaccines in a short trial - long term side effects and durability of the immunity. I mean, it's not physically impossible. You could take a few hundred participants, vaccinate them, put them on a ship going at some percentage the speed of light, and then see if they have any side effects and do a challenge study to see if they're still immune. Short of playing with the fabric of space time (and ethics) - you're not really getting that data from any of these trials, which is why as I mentioned even with completed trials this timeline js unprecedentedly short.

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

#125

Post by JMTQp8lwXL » Tue, Sep 08, 2020, 8:00 PM UTC

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?

The effect needs to be strong, because in ordinary times, many social circles cross paths and a much higher level of human contact occurs. The average person won't read into the nuance of 'the vaccine is X% effective, depending on risk factors Y and Z'. They'll rush to their ordinary behavior. While there isn't a vaccine, it's easier to obligate folks into social distancing. That strategy won't exist anymore once we have a vaccine, regardless of its efficacy.

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

#126

Post by garmaine » Tue, Sep 08, 2020, 8:01 PM UTC

RHSeeger wrote: post #80

calvinmorrison wrote: post #65

Earlier quoted context omitted.

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'd rather more people die to Covid than find out 20 million people have failing livers and 5 million were born with birth defects because they rushed a vaccine without enough testing.

COVID has already caused at least that many people to have measurable levels of internal organ damage.

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

#127

Post by takeda » Tue, Sep 08, 2020, 8:01 PM UTC

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.

And not working that's actually the better outcome of a bad vaccine. It could also have side effects that are worse than COVID-19.

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

#128

Post by onetimemanytime » Tue, Sep 08, 2020, 8:02 PM UTC

farias0 wrote: post #101

onetimemanytime wrote: post #47

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.

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.

They are hundreds of vaccines in work. Not really. The rich are hunkering down and no one is rushing to use the Russian or Chinese one

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

#129

Post by SpicyLemonZest » Tue, Sep 08, 2020, 8:02 PM UTC

JMTQp8lwXL wrote: post #125

SpicyLemonZest wrote: post #70

Earlier quoted context omitted.

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?

The effect needs to be strong, because in ordinary times, many social circles cross paths and a much higher level of human contact occurs. The average person won't read into the nuance of 'the vaccine is X% effective, depending on risk factors Y and Z'. They'll rush to their ordinary behavior. While there isn't a vaccine, it's easier to obligate folks into social distancing. That strategy won't exist anymore once we…

I agree, but that's what the challenge is. We have to solve for the values of X, Y, and Z where we're comfortable with people's inevitable rush back to their ordinary behavior, and it's extraordinarily hard to figure out what those values should be.

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

#130

Post by mumblemumble » Tue, Sep 08, 2020, 8:02 PM UTC

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.

According to FDA, phase III trials typically take 1-4 years.

It's worth noting that, if there are any adverse effects that take a while to become apparent, the trial will need at least that long to be able to detect them. To my knowledge, severe vaccine reactions usually happen fairly soon, but a year before onset isn't necessarily unheard of for some vaccines. Also, that's just for vaccines that got approved; there may be some selection effects there.

The bigger one I'm worried about is whether or not the vaccine will confer lasting immunity. If we rush a vaccine to market in six months, everybody gets it, and returns to their pre-pandemic lifestyles, then we'll be in for a nasty surprise on down the road if it turns out that it only confers immunity for a year. It seems to me like we need to consider the possibility that an imperfect vaccine is worse than no vaccine at all.