Belgian experts 'shocked' as AstraZeneca seeks liability waiver for vaccine | Hacker News Reader

Belgian experts 'shocked' as AstraZeneca seeks liability waiver for vaccine

brusselstimes.com

51 pointselorant48 comments

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.

I am curious about this claim.

Someone else in another post a few weeks ago that large pharmaceutical companies take in a ton of funding from investors and governments around the world during research. If it doesn't ends up being successful, they're fine.

However if you're a small time actor or startup, it's pretty much win or die that you have as options as the same lucrative funding isn't available.

This vaccine was developed by Oxford University. AstraZeneca stepped in to produce it rapidly. They don't normally produce vaccines at all, but they do have very capable production facilities and people. In this case they committed to ramp up production several months in advance of the stage 2/3 results, because production ramp-up takes a long time and we really need a vaccine quickly. Yes, seems odd for big pharma to commit production resources with no prospect of big returns, but that's what they've done. Probably some of those production facilities were running under capacity anyway, as cancer treatments, etc have been postponed this year. I guess if it works, it will at least be a huge PR win, especially for their CEO who's gone out on a limb to make this happen.

https://www.bbc.co.uk/news/business-52917118

Would you care to share your source? Thanks.

https://www.astrazeneca.com/media-centre/press-releases/2020...

If you're looking for different articles from other sources (as opposed to this press release), you can find quite a few more by going to your favorite search engine and trying a query like "astrazeneca vaccine cost"

> They will make no profit from it, so you cannot really expect them to also accept liability.

Wow. "Companies should only accept liability if they make profit" is a very bleak view of the world.

If a company faces liability for something on which they can't recoup a profit, they will tend not to do that thing at all, as it would be per se irrational. That's the point the commenter is making.

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.

> 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 ?

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.

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

You are using two different meanings of “government”, one refers to the machinery of state and one to the regular political leadership of that machinery endowed with certain powers by virtue of meeting certain procedural rules. The first is where the liability lies and is not interrupted, the second is interrupted as a result of no leadership currently meeting the procedural standards, but not critical to the issue at hand.

This vaccine is the Oxford vaccine. It has been licensed at no charge to India, Russia and Argentina/Mexico and Australia to produce their own vaccines. They all agreed to sell at manufacturing cost. Around $3-4/dose to manufacture.

And it’s not just them either. The Serum Institute, the world’s largest vaccine manufacturer (based in India), is taking huge risk both manufacturing at cost and scaling up manufacturing of the Oxford/AstraZeneca vaccine ahead of trial completion: https://www.nytimes.com/2020/08/01/world/asia/coronavirus-va...

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.

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/2020/08/11/world/europe/russia-coron...)

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.

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.

Good, fast, cheap: pick two.

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

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?

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)

You can maybe give higher doses or look really carefully for early signs of something being wrong? But I guess you can't do it as accurately as accelerated aging tests in eg. mechanics.

The project management triad is a spectrum, not three boolean values, and not all of the areas of the triangle are necessarily within the bounds possible choices. (For example, consider how many bids you might expect on a project with a budget of zero)

Marginally speaking, governments are demanding this vaccine at same/lower prices and more accelerated timeline. AZ reasonably sees an associated rise in risk with this, which at the end of the day, is a cost for them.

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.)

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.

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.

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.

"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.

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.

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.

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.

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.

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.

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.

The problem is, by the time we know what the best course of action is, it will be much too late to take that action.

I think the data on vaccines that have been around for decades is clear, but new vaccines are always going to have unknown risks. New diseases also have unknown risks. It's hard to weigh unknown risks and decide what's the best action to take.

There's effectively zero chance that the vaccine kills 1% of those vaccinated. They would have caught that in the Phase II, and probably the Phase I since they do also track adverse events short of death.

The risk is e.g. that the vaccine has unforeseen side effects that kill or seriously injure one person in 10^4 or 10^5. That could still be a highly favorable tradeoff for society; but if AstraZeneca gets no credit for the people their vaccine saved and pays out normal rates--potentially billions of dollars--for the people their vaccine injured, then it's a terrible tradeoff for AstraZeneca.

All vaccines present some version of this problem, and that's why the American government takes liability for vaccine injuries. I'd guess that Europe has been able to avoid that (so far) only because their socialized health care reduces the need for injured patients to sue to recover their medical expenses, and because of their less litigious society in general.

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?

Not particulartly unlikely actually:

Some Examples: - Philippines dengue vaccine debacle https://www.npr.org/2019/05/02/719366831/dengue-vaccine-cont...

- The rushed flu vaccine in the US in response to the 1976 outbreak https://en.m.wikipedia.org/wiki/1976_swine_flu_outbreak

Different underlying mechanisms (Dengue is a bitch where you get immunity against one strain but significantly increase the chances of a hemorrhagic event if you get any of the other strains for example)

Given how little we know about covid and its family (Sars burned out, MERS never got the investment it needed to understand), rushing is a very bad idea(tm). But so was pretty much most of the inept response so far, so yea...

Longer list from the CDC here, you can see a variety of causes from simple manufacturing mistakes (given how we did on producing rushed tests....) to complex side effects - https://www.cdc.gov/vaccinesafety/concerns/concerns-history....

Its worthwhile noting that the scale here is the most scary part. Most vaccines are limited to specific situations or age / risk / region groups and have years of testing and real world data behind it, following gradual rollout over the world - but the covid one will be applied universal to potentially billions in a short time. Rushing that is, well, an unfathomable risk.

Edit: Judging from the reaction this isn't what certain people wanted to hear. Well, we are in this mess because of exactly that attitude. Nature does not care for our wishes and we better grow up sooner rather than later.

A polio vaccine introduced in the 1930s could paralyze kids.

https://en.m.wikipedia.org/wiki/Polio_vaccine

I did some research on this in my spare time. It's about as likely as the long term side effects of the covid19 itself(unknown), but to a lesser extent. If we take the Flu vaccine for example, it causes some autoimmune disease at rate 15 times less than the actual Flu virus. Flu vaccines are the most tested.

There are nastier less tested vaccines out there that score worse, but still better than the actual viruses. That being said a virus doesn't infect the whole population in general, while for a vaccine to be effective you have to push it out widely thus reversing the win a little bit. I am sure there is an equation out there that balances the risk.

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.

https://yle.fi/uutiset/osasto/news/finnish_researchers_zero_... with more information in related links at the bottom.

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...

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

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.

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

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

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