
Belgian experts 'shocked' as AstraZeneca seeks liability waiver for vaccine - elorant
https://www.brusselstimes.com/belgium/127905/coronavirus-belgian-experts-shocked-as-astrazeneca-seeks-liability-waiver-for-vaccine/
======
mhandley
This article misses the important piece of information that AstraZeneca is
producing this vaccine _at cost_. They're already taking a large financial
risk up front by scaling up production in advance for a vaccine that may not
pass stage 3 trials, so may not be approved for use. They will make no profit
from it, so you cannot really expect them to also accept liability. These are
unusual times, and they require unusual approaches.

~~~
nocturnial
What this english article also misses is that the Belgian government becomes
liable for the damages. This was discussed in the local press.

Anyways, if the fine print of the contract indeed stipulates that they will
sell it at cost, then I see no problem with it. The problem is that I doubt
this is the case otherwise they could give up their patent and let countries
produce the "generic" version. In return they will be refunded for their
research and can keep their know-how.

~~~
antpls
> What this english article also misses is that the Belgian government becomes
> liable for the damages. This was discussed in the local press.

How does that work when there is no government, as in Belgium ?

~~~
stef25
We do have a govt, it's just the elected parties that can't agree on how to
govern together so in the meantime there's some interim setup. Or something
along those lines. It's such a non issue that nobody even notices. I wonder if
anyone at all is impacted.

~~~
nocturnial
Yes, we're living in an advanced democracy. The country doesn't grind to a
halt when there's a political disagreement.

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dutchmartin
It could be a cover up for something that is wrong, but maybe they do this to
compensate on the shortened testing. Because longer testing on patients reduce
the risk on unknown side effects. They obviously do not want to carry that
risk and thus we here see the result.

~~~
an_opabinia
I don't think there's a coverup.

At this point trial design and regulations are decided foremost by politics.

Nothing will determine if the trial is successful other than serendipity, so
in my opinion, while people should not suffer due to side effects, none of
this stuff really matters.

Another way to look at this is, in a place that has no elections, like China,
or in a place with unfair elections, like Russia, but a surplus of talent and
money to develop vaccines, vaccine development is pretty unusual.
([https://www.nytimes.com/2020/07/16/business/china-vaccine-
co...](https://www.nytimes.com/2020/07/16/business/china-vaccine-
coronavirus.html) [https://www.nytimes.com/2020/08/11/world/europe/russia-
coron...](https://www.nytimes.com/2020/08/11/world/europe/russia-coronavirus-
vaccine-approval.html))

~~~
bserge
How is it decided by politics? Russia is extremely good at pushing through
medication because there are no politics.

They don't care, they just approve and release stuff like Google releases beta
versions of their products and lets the users be the guinea pigs that will
provide feedback on how well it works and what needs improvement.

That's a terrible way to do it.

~~~
an_opabinia
I think I was downvoted because it was hard to interpret my politics.
Obviously I am pro safe vaccines with legitimate trials.

I meant to say: producing a vaccine is seen by people as a political issue.
But in reality it is a serendipity issue. Fundamentally there is nothing a
politician can do, no amount of money they can spend, no prohibitions they can
lift, to help you discover the vaccine. People think that there is, but there
isn't.

However, you CAN just get rid of trials, or skip some, or say something works
when it doesn't, laundering the reputation of an otherwise trustworthy
regulatory body by fiat. It will look good, if you are in power, if you
produce a "vaccine." It won't work, because there is nothing you can do to
make a working vaccine. But it will look like it does, and maybe, if too few
people get the disease, it won't matter, you'll get reelected, the problem
doesn't matter anymore.

What's interesting is places where they do not have elections (or legitimate
elections) - vaccine development looks even weirder. There's no way to
anticipate how the Russian or Chinese government will reframe the COVID
crisis. We see side effects of this in the totally bonkers vaccine testing and
announcements in these places.

In Belgium where this takes place, like whether or not AstraZeneca has the
vaccine that works - that's serendipity. It won't matter what Belgian
politicians say or make them sign or whatever. They want something impossible,
a guarantee from a company that is just a serendipity play. So maybe they've
decided, okay, maybe we should look strong on trial regulations? That will
help some particular Belgian politicians get elected, because the opposition
actually supports more flexible trials? Who knows, I am not a specialist in
Belgian politics. But because the vaccine will be discovered by serendipity,
because it will not scale with ethics or more money, I am confident it won't
matter to the outcome of the actual vaccine.

------
kube-system
Good, fast, cheap: pick two.

~~~
rightbyte
No amount of money will discover long term effects in the short term.

~~~
rzzzt
A counterexample from a non-biological domain would be accelerated aging tests
of electronic equipment. Could there be any similar approach that aims to do
this in pharma testing?

~~~
kube-system
The project management triad doesn’t tell you what is scientifically possible
— it tells you what is economically impossible.

Adding money won’t shorten the timeframe here, but shortening the timeframe
adds potential risks (and risk=dollars)

------
stef25
Belgian here, used to work for big pharma. The current procedures for clinical
trials (very long, very expensive) were put in place after Thalidomide (google
it).

Pharma companies are terrified of this happening again, especially in a
situation like this one where all eyes are on them. They follow FDA / EMEA
rules to the letter and cutting corners is something nobody wants to do. I'd
say those "shocked experts" aren't really experts at all.

Some side effects simply can't be manifested during clinical trials since it
will only occur once every 50 - 100.000 patients. If you test your vaccine on
5000 people and then proceed to vaccinate 4 million, there's a remote
possibility that some of those (or worse, their offspring) will suffer serious
side effects and it's totally normal they don't want to be held on the line
for that simply because they had to hurry up.

In the world of software development we know that having to hurry up never
leads to anything good, now imagine there's a pandemic, people's lives are at
stake and you're to be held liable for possible bugs - no thanks.

(Anecdote: Pharmacovigilance is the practise of monitoring a drug basically
forever. Quite recently it was discovered that domperidone (an OTC drug
against nausea) led to an increased chance of serious heart problems and it
lost its OTC status. This was after several decades of widespread use.)

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walterbell
Can politicians be made personally liable for bypassing laws which impose
liability on companies who harm citizens? Elections are too late, the harm
would already be done.

This would be similar to company officers who bear liability for sufficiently
serious crimes, removing some incentives for regulatory capture.

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pkaye
I see a couple options:

* Belgians do their own trials to determine vaccine risks vs coronavirus risks.

* Negotiate a new price that accounts for liability.

* Negotiate with another manufacturer that allows liability.

* Wait a year or more to better understand vaccine risks.

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m0zg
It's interesting that they aren't requesting a liability waiver for the case
when it doesn't have side effects, but simply doesn't do much, like the flu
vaccine, due to how quickly the virus mutates. Because that could easily
happen as well. Others aren't requesting that either. This sounds reassuring,
in the sense that they don't try to CYA for charging billions for something
that doesn't work.

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missedthecue
_" We want you to make a simple, mass-producable vaccine, for no profit, in
world record time, with many shortcuts taken in the approval process, and oh,
if it has any side effects at any point in the future, you're on the hook for
them"_

Hmm. I'm not one to usually take the side of pharmaceutical companies, but
here we are.

~~~
Hoasi
Not at all, let's give them a profit, but pay for a decent, reliable product,
that's the idea. You don't pay beforehand for something that can potentially
turn to be a disaster, without any liability whatsoever.

~~~
bpodgursky
There's literally no way to get a guaranteed reliable product with shortened
phase-3 trials.

You can't accelerate time. You can get huge numbers of subjects, even do
challenge trials, and throw every scientist in the world at it, but you cannot
look at the 1-2 year effects or efficacy without 1-2 years.

What you said is a very nice platitude which is simply not possible given the
time constraints involved.

~~~
tehjoker
This kind of rhetoric is making my vaccine safety alarm bells go off. We are
considering administering this vaccine to a decent percent of the world
population. If it has 1% deadly side effects, it's as bad as corona, but self
inflicted. Maybe we should rethink whether rushing this is a good idea in the
first place.

~~~
Spartan-S63
We really should be carefully considering the risks of this accelerated
vaccine development. Though, I don’t think it’s realistic we’ll be able to
actually consider the _real_ risks because the world is in a mode of always
wanting to find the silver bullet at all costs - even when one doesn’t exist.

We’re in an unprecedented time where people think that a COVID-19 vaccine will
allow us to stop social distancing and wearing masks. With the efficacy
targets of these developments, that won’t do. We need defense-in-depth _even
with_ a vaccine. Once we have it, great, we can open more things up, but
social distancing and masks still need to be worn until the virus becomes
endemic.

I still wish the US had invoked the Defense Production Act and pressed the
public and private sectors into work on a vaccine and manufacture of PPE. The
fact that we didn’t is telling of how drastic leaders want to respond to this.
In my view, this is a war against a virus, but we’re not acting like the
situation requires a war-levels of effort.

~~~
tehjoker
I agree with what you said. I am very concerned about the well documented
possibility of vaccines sometimes making the disease course worse or causing
auto-immune problems down the line.

After all, one problem with sars-cov-2 is that the virus mimics human self-
identification all over the place, one reason it is so effective. What if a
non-negligible part of the population develop a chronic auto-immune disease?
Those diseases are treated with steroids. If we have to give immune-
suppressing steroids to a large part of the population, are we not setting
ourselves up for a second pandemic?

These are just speculations, but I am extremely adverse to this rush mentality
like we're trying to get a new software UI out and it doesn't matter if it
breaks. While we are under the gun here, I still think we should take a
considered approach and indeed mobilize against the virus. Much of this
mobilization would involve not only production, but also non-production i.e.
paying people to stay home and building structures that enable safe
socialization etc.

There's a mentality that we must preserve our highly competitive way of life
at all costs, and the people leading us are the ones that "won". I think this
is the wrong course.

Further, I think this discussion of liabilities and profits is insanity. The
relevant phrama companies should be nationalized and anyone harmed should be
able to make a claim against the government. I don't understand why an entire
civilization needs to rely on the kindness of buisness people.

~~~
Spartan-S63
Absolutely. I agree. Production of remedies is just as important as non-
production of non-essential industries. The fewer people there are out and
about, the better off we are during this pandemic. The fact that there's been
so little direct aid to people directly impacted is baffling to me.
Corporations don't need money to sustain themselves. That's classical neocon
supply-side thinking at work. We're in a situation where demand-side thinking
and stimulus is critical.

If nothing else, I have a foolish hope that this pandemic will force us to
reexamine our way of life and alter it to be more community-centric and relax
our competitiveness. There's no reason life has to move at the speed it does.
There's no reason the workweek needs to be 40 hours. There's no reason parents
can't spend more time with their children and all people can have more leisure
and unstructured playtime.

And finally, I 100% agree. I have little faith in most corporations that are
doing things that shouldn't be scarce goods - such as medical care and
pharmaceuticals. Relying on them to deliver us through this disaster is
foolish. Their incentive is _not_ on getting us through this. It's on
delivering shareholder value and right now, they're delivering all kinds of
value since they're in higher demand. We should view it as a failing when
private industry is our only hope of deliverance from a disaster.

------
devit
How likely is it that a vaccine would have long-term side effects? Have there
been past cases of it? Is there a plausible biological mechanism that could
cause this?

~~~
noinsight
In Finland all school aged children (afaik) were vaccinated against the recent
swine flu outbreak and then it was discovered it led to narcolepsy in some
cases...

On phone atm so no sources.

~~~
randomfinn
[https://yle.fi/uutiset/osasto/news/finnish_researchers_zero_...](https://yle.fi/uutiset/osasto/news/finnish_researchers_zero_in_on_link_between_pandemrix_vaccine_and_narcolepsy/7692372)
with more information in related links at the bottom.

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hn_throwaway_99
I don't know how it works in Europe, but I actually think the vaccine
liability program in the US makes a ton of sense, ensuring that companies are
still incentivized to make vaccines, while injured people can still get
compensatiom. Honestly, I wish more medical malpractice law worked like this
(IIRC malpractice law in the Netherlands or Denmark does generally work from
this "no fault" baseline).

See the Wikipedia entry on the National Vaccine Injury Compensation Program,
[https://en.m.wikipedia.org/wiki/National_Vaccine_Injury_Comp...](https://en.m.wikipedia.org/wiki/National_Vaccine_Injury_Compensation_Program)

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YarickR2
They could radically slash costs by purchasing Russian vaccine, then )

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Hoasi
That is a bully move. The country should retract from this, open the bid, and
see if AstraZeneca still wants to participate with fair rules in place.

~~~
LanceH
Or AZ prices in the risk or delays delivery to Belgium by 4 years.

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ramblerman
I see a lot of people coming to The defense of AstraZeneca here. I guess it
must really be a cultural difference.

We are not talking about Personal liability here. But the company itself
should be accountable that the products it puts out there are safe.

It’s normal that politicians are desperate for a quick fix. That doesn’t mean
we should forego the normal laws of drug safety

