
AstraZeneca exempt from coronavirus vaccine liability claims in most countries - ColanR
https://uk.reuters.com/article/us-astrazeneca-results-vaccine-liability/astrazeneca-to-be-exempt-from-coronavirus-vaccine-liability-claims-in-most-countries-idUKKCN24V2EN
======
simonblack
That raises a huge red flag in my mind over its safety.

Big pharmaceutical companies have a history of marketing drugs that aren't
quite as good or harmless as they are made out to be.

~~~
foobarbazetc
Not that it’s relevant in this particular case, but I don’t take anything
that’s only approved in the US, because the FDA really doesn’t care, and
especially doesn’t care right now.

Most drug companies actually view the US as the beta test country in a lot of
ways.

If something makes it to Australia (who are very strict on pharmaceuticals)
then it’s usually pretty safe.

~~~
refurb
As someone who has worked directly with the FDA, this is an absurd position.
If anything, the FDA errs on the side of causing no harm versus getting a much
needed treatment approved.

And it might be good to know that most countries approve drugs based on the
same data - global clinical trials. Australia is looking at the same data as
the US when making an approval decision. Some countries require local trials
(China and India, I believe).

In addition, there is plenty of collaboration across drug approval bodies when
developing or changing regulations. They are all talking to each other to
determine the best approach.

Here is a good example of the FDA and TGA (Australia) and Canada approving a
new cancer drug together[1]

[1] [https://www.fdanews.com/articles/192766-fda-approves-
first-c...](https://www.fdanews.com/articles/192766-fda-approves-first-cancer-
drugs-in-collaboration-with-tga-and-health-canada?v=preview)

~~~
jdietrich
Several aspects of FDA regulation are widely regarded as inadequate, in
particular the 510(k) process for medical devices and Section 901 of the
FDASIA.

FDA approval is slow and expensive, but the political pressure to change that
situation has created myriad alternative routes to market authorisation rather
than a fundamental reform of the process. Far too many drugs and devices have
sneaked onto the market with lower standards of scrutiny and the FDA's post-
marketing surveillance isn't up to the task.

The FDA knew about rofecoxib's cardiovascular risks for years and did nothing;
they've known about rosiglitazone for years and they've done very little. It's
just too easy for bad products to get on the market and stay on the market
under the FDA's less-than-vigilant gaze.

~~~
refurb
_Several aspects of FDA regulation are widely regarded as inadequate_

I think that's a matter of opinion, rather than a purely factual statement. It
intersects with your comment "Far too many drugs and devices have sneaked onto
the market with lower standards of scrutiny", because it begs the question
"how many is too many?".

It's all a trade-off. The higher level of scrutiny requires more time and more
money and can result in people being denied drugs that could have prevented
harm or death.

It's my own personal opinion, but I think the FDA does a pretty good job
considering the judgements they are asked to make.

And rofecoxib was eventually pulled, but only after careful scrutiny of the
risk. It's not hard to do a retrospective analysis and see a safety signal.
Pulling a product based on limited data means you may be doing harm by denying
people a drug that helps them. Before the COX2s existed, perforated ulcers due
to NSAID use weren't exactly rare.

And I'll just end with one final comment - overseeing a safe and effective
drug supply _is really damn hard_. So I try and take that into consideration
when evaluating the FDA's (or any countries drug agency) actions.

------
IfOnlyYouKnew
That's probably... fine?

these vaccines are developed in a process far more open than any typical
pharmaceutical research. The risks at issue here are unlikely to be of the
bad-faith variety that can be discouraged with liability.

Instead, these will be genuine known and unknown unknowns. There will be a lot
of scrutiny, which will allow governments and the public at large to make
these decisions under uncertainty with the benefit of the best possible
information at the time.

With the company not enjoying a significant informational advantage, the moral
and practical case for liability just doesn't make any sense.

That is a standard approach for the otherwise intractable collision of a legal
system that apportions the damages of anything that goes wrong on the party
mostly responsible for it, and the medical reality of almost all interventions
coming with _some_ potential for grievous harm: by default, your surgeon would
always be "responsible", in sense of civil law, not morality or criminal law.
Because the general principle allocates responsibility with those making
decisions.

"Informed consent" is about getting you into a position to make decisions, and
thereby share in the responsibility.

~~~
WalterBright
> apportions the damages of anything that goes wrong on the party mostly
> responsible for it

That is usually interpreted to mean the party with the money gets stuck with
the damages. Nobody sues a penniless person.

------
pastrami_panda
In Stockholm about 20% of the population now have antibodies, despite a lot
social distancing. We have plenty of hospital beds ready in the event the
number of people with respiratory problems would rise. No one is using face
masks and the official consensus is that it doesn't provide enough
contamination protection to be currently worthwhile. We keep our gatherings
small and avoid crowds or close interactions where possible. Our authorities
in control of elderly homes really did screw up in the early parts of the
outbreak though, and a lot of elderly people lost their lives because of that.
But overall things are moving toward a more normal society each day. I'm far
removed from the belief that we need a rushed vaccine to cope with this
pandemic. I can't speak for other countries and their strategies though but
this is a local correspondence from the ground sort of speak.

~~~
fpgaminer
> In Stockholm about 20% of the population now have antibodies, despite a lot
> social distancing.

Maybe ... it's because of this:

> No one is using face masks and the official consensus is that it doesn't
> provide enough contamination protection to be currently worthwhile.

All the evidence I've seen is quite clear; masks are effective.

And let's consider that the U.S., seen by many to be the worst handler of this
pandemic thus far, is currently only ~8% of the way done. Yet Stockholm has
already _blown_ through 33%.

Sweden, on the whole, is at 9.4%; again surpassing the U.S. by a good chunk.

I feel like the point of your comment was to suggest that Stockholm is doing
well. The data is clear that they are not. In fact, they are doing quite
poorly. I would take a good hard look at anyone in your government not
vehemently pushing for mask use.

> I'm far removed from the belief that we need a rushed vaccine to cope with
> this pandemic.

I cannot for the life of me fathom why the impending death of 60,000 fellow
citizens, and 600,000 disabled with chronic illness wouldn't convince someone
that a vaccine is needed ASAP.

~~~
pastrami_panda
> I cannot for the life of me fathom why the impending death of 60,000 fellow
> citizens, and 600,000 disabled with chronic illness wouldn't convince
> someone that a vaccine is needed ASAP.

I deliberately wrote that a _rushed_ vaccine is not needed. All the side
effects need to be carefully considered. Even some vaccines that weren't
necessarily rushed proved to have really horrible side effects when deployed
to the population at scale.

I'm simply saying Stockholm is probably approaching 50% immunity soon (T-cell
+ antibody). If you isolate the outlier event that is the very poor treatment
at the elderly homes at the start of the outbreak, causing a huge part of our
deaths numbers, you get a completely different picture.

~~~
ChrisLomont
It’s not clear you get permanent COVID immunity, just like you don’t get
lifelong flu immunity. The Swedish gamble may become a cycle of unneeded
deaths.

And people gave you solid evidence that Sewdish numbers are not the result of
early elderly outlier events. You should stop claiming that in so many posts
when it seems untrue.

~~~
anoncake
If there is no permanent COVID immunity, a vaccine won't give it to you either
and we might as well stop delaying the inevitable now.

~~~
ChrisLomont
That’s just nuts.

Just like people get flu shots every year to prevent widespread outbreaks, a
Covid vaccine that gives temp immunity would save millions of lives.

Why do you think there’s such a big deal about people getting annual flu
vaccine shots, especially the most vulnerable?

~~~
anoncake
There are 7.8 billion people on Earth. A vaccine that saves a few million
isn't worth making billions put their lives on hold plus all the collateral
damage that causes.

~~~
ChrisLomont
Pandemics of this size in the past destroyed economies as people decided to
hide, so you're going to get that damage no matter what. By getting it under
control, the damage is minimized as many countries that followed best
practices has shown.

Those countries that tried to do what you suggest are the ones with the
longest economic downturns.

You should read about pandemics of the past.

And as very solid evidence from experts, the famous IGM economists poll of
most of the world's top economists covered this exact question [1], which I'll
repeat:

"Abandoning severe lockdowns at a time when the likelihood of a resurgence in
infections remains high will lead to greater total economic damage than
sustaining the lockdowns to eliminate the resurgence risk"

100% of them selected Strongly Agree (41%) or Agree (39%) or Uncertain (14%),
not a single vote on any part of the Disagree spectrum, which is nearly
unheard of for a question in economics, and these responses were also rated
highly confident. Check other questions and polls to see how rare this strong
of a response is.

Shortsighted action ignorant of the history of economics almost always makes
things worse.

Have a good day.

[1] [http://www.igmchicago.org/surveys/policy-for-the-
covid-19-cr...](http://www.igmchicago.org/surveys/policy-for-the-
covid-19-crisis/)

~~~
anoncake
Not everything is about the economy.

------
PragmaticPulp
In the United States, an existing law from 2005 likely already covers these
cases anyway:

> The United States, however, already has a law to exclude tort claims from
> products that help control a public-health crises in the form of the 2005
> Public Readiness and Emergency Preparedness, or PREP Act.

It's also important to note that AstraZeneca has also pledged to supply the
doses with no profit:

> AstraZeneca, Britain’s second-largest drugmaker, has pledged to supply a
> total of more than 2 billion doses at no profit in agreements with the
> United States, Britain and European countries, among other nations and
> organisations.

The exemption from liability claims is a function of the massive scale, the
rushed timeline, and the lack of profit to defend claims in court.

When you're supplying a vaccine at the scale of billions of people, it's
inevitable that many people will convince themselves that the vaccine is the
cause of unrelated medical issues. Even if the vaccine turns out to be just as
benign as every other vaccine out there, having tens or hundreds of thousands
of people attempt to sue these companies under the mistaken notion that the
vaccine caused their problems could be extremely costly.

The alternative would be a much more expensive vaccine (profit margins to
buffer against potential losses) delivered much later (additional _years_ of
safety testing and R&D).

------
pama
The risk is very high that such agreements lead to long term harm by providing
fuel to anti Vaxxers and reducing the effectiveness of vaccines. Wasn’t this
scary example enough for politicians to learn to forever kill these kind of
deals? [https://www.buzzfeed.com/shaunlintern/these-nhs-staff-
were-t...](https://www.buzzfeed.com/shaunlintern/these-nhs-staff-were-told-
the-swine-flu-vaccine-was-safe)

~~~
new2628
It's amazing that the only danger you see is that it is fuel to anti-vaxxers.
What if it is actually harmful at scale?

~~~
DanBC
Read the link, they give an example of a vaccine (pandemrix) that was harmful
at scale. 1 in about 50,000 people given pandemrix developed narcolepsy.

------
aaron695
“This is a unique situation where we as a company simply cannot take the risk
if in ... four years the vaccine is showing side effects,”

It's going to be well known any of the vaccines available will be considered
risky.

I'm not sure people are considering how society will react to that.

~~~
Mirioron
> _I 'm not sure people are considering how society will react to that._

There will be a decent chunk of people that will be very apprehensive and they
will probably be relentlessly shamed for their apprehension. Look at the
amount of shaming that goes on regarding masks. I don't think there would be
any less for a vaccine that somebody doesn't want to take. It'll probably just
deepen the divide between people even further.

It's also completely reasonable for the company to take the stance they do.

------
refurb
This should not surprise anyone. Giving an exemption from vaccine injury is
pretty standard and there is a fund for payouts if children are injured by a
vaccine. This isn’t the only exemption.

[https://en.m.wikipedia.org/wiki/National_Childhood_Vaccine_I...](https://en.m.wikipedia.org/wiki/National_Childhood_Vaccine_Injury_Act)

------
Animats
The US has nationalized liability for vaccines. It's a consequence of a number
of mostly-bogus lawsuits. Vaccines are in general not very profitable. No
repeat sales.

 _" Cures are nice, but the money is in chronic conditions."_ That's all too
real. Look at the history of ulcer treatments.

------
jarym
I understand why but on the other hand, there is a sense these vaccines are
being rushed and the obvious question is what corners have been cut (if any).

The last thing we would need is for anti-vaxxers to have a genuine concern and
this raises many red flags.

So many governments have failed at every turn to deal with this virus it
hardly inspires confidence that we should trust them on this especially as
they are all desperate to get economies back on track so their own control
procedures may be softened. And if there are significant side-effects I doubt
there's globally any 'compensation' fund large enough.

~~~
ghthor
Dont worry, anyone that had a kid legitimately hurt by a vaccine is looking at
the people cheering on a vaccine and thinks you are crazy.

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supernova87a
I wonder if any stats or math go into this decision, and what the
thresholds/limits of risk are? Or perhaps they're programmed into the criteria
for what is accepted as the eventual vaccine.

Because this decision is most definitely making a call about the value of
saved lives / avoided sickness, versus the likelihood of unintentionally
caused sickness due to vaccine side effects.

I wonder what the acceptable numbers / risk percentages are.

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mzs
It's probably because of the adjuvant. It's needed for the vaccine to be
effective but people can have reactions to it. With so many people to get
vaccinated it could lead to frivolous class actions.

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svrb
The scary thing is that anyone who takes the scientific approach and to wait
and see if the drug has serious side-effects will be accused of being anti-
vaxx and socially ostracized.

------
jahaja
So for a for-profit corporation to produce a vaccine it needs to be completely
risk free? This is not the first time market forces are suspended as soon as
something needs to be reliably done.

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rolph
with no liability it wont matter if the vaccine is saline or cyanide or safe.
where is the motivation to get it right?

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sys_64738
The Zeneca part is formerly ICI of toxic chemicals fame. Some things never
change.

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rubyn00bie
I am okay with this... mostly because I don't think even someone/organization
with the best intentions could possibly ship this without establishing this
sort of clause up front.

If anything, not doing so, would make me _more_ concerned because it seems
like overconfidence, or refusing to acknowledge how long it normally takes to
do clinical trials on something before releasing it the public.

I know there are predatory pharmaceutical companies who would put their own
profits way ahead of others... I just don't think in a global pandemic its
going to be easy to intentionally lie about, or misrepresent, the effects of a
cure to said pandemic. No amount of signed contracts would protect the company
from the sheer volume of people marching to take their heads.

