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Comment by rsynnott | Hacker News Reader

I think in years to come, the story of the AstraZeneca vaccine is going to make for some fascinating documentaries. The whole thing has been a series of weird problems from start to finish (starting with AZ being chosen as the partner in the first place, arguably).

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According to "Le Canard Enchainé" [0] this is because:

  - They agreed not to make profits on the vaccines for the first year or so (that was imposed by Oxford)[1]
  - There's no penalty for not reaching the delivery targets in their contract with the EU.

So since they have no financial incentives in delivering more, they simply subcontracted the production, and are not making much effort in solving the various production issues.

[0] A famous, print only, French political news-paper, which is generally considered quite reliable.

[1] https://www.ft.com/content/c474f9e1-8807-4e57-9c79-6f4af145b...

Seems to be working just fine in the UK, US, India, Hungary, so I don't think any of the issues are to do with Astrazeneca.

But the politics of it, absolutely.

It’s not authorised in the US and the federal regulators keep raising their eyebrows at the data.

this is something i don’t get: if it works all around the world why aren’t the federal regulators simply fast tracking its approval?

are they not allowed to do that?

Observational studies are a lower standard of evidence than randomised controlled trials. Countries with higher levels of vaccine skepticism (eg the US) seem to be erring on the side of doing things by the book. The UK, by comparison, enjoys a high degree of trust in its healthcare system and can afford to be a little more gung-ho.

interesting thanks.

how long would a randomised controlled trial take?

The AstraZeneca US phase 3 trial took about 7 months.

https://clinicaltrials.gov/ct2/show/NCT04516746

In this case, US regulators took issue with the company's press release, rather than the results of the trial itself.

Who says AZ works around the world? It's the vaccine of the last resort, people will get it only if they can't get anything else because it's still better than nothing, at least for now.

And "better than nothing" is just temporary because AZ is very to completely ineffective against all virus mutations that are currently spreading.

If Russian and Chinese Sputnik and Sinovac vaccines were approved in the EU, we could save so many lives, but politics will rather try to force AZ than accept that they failed.

> Who says AZ works around the world?

all the authorities that have approved it? all the people that got it? we're talking tens of millions of people and authorities across the planet.

and those authorities approved it because it's good and effective, or because it's the only one available on the market?

Because normally they can get away with a drawn out process that takes years, and if in one country some medication is curing cancer and in another country is not approved, nobody bats an eyelid.

It’s a big bunch of fiefdoms that all want to do their own checks and it is a political minefield. Witness the ridiculous situation with the vaccination shutdown last week. Has nothing to do with science, everything with public image and politics.

And it’s setting themselves up to fail as well because in this situation if a manufacturer has contracts with countries A and B and A pays more, they’ll just focus on approval for country A and delay approval for country B, so it’s perfectly defensible to only deliver to country A and not the country who isn’t going to use it anyway.

Unfortunately this is all smoke and mirrors that goes way over the head of the general public so there’s no backlash for failing.

AZ has had severe production issues. AZ's working in the UK because they're getting most of the production, but they've delivered only a small fraction of what they said they would in the EU. They've also had _two_ botched trials now, leading to delays in approval (a couple of months for the EU, nearly six months for the US). And now this.

Aren't the issues created by over-regulation and bureaucrats throwing their spanners everywhere to cover their own incompetence?

There's no evidence supporting that claim, and there have been no such problems with the Pfizer, Moderna and Johnson vaccins which had to comply with the same regulations.

These other vaccines are produced for profit so there is money to be made under the table for bureaucrats, whereas AZ does not have this potential. If bureaucrats can stamp out this vaccine they can make more money pushing the others. Have you not seen the fake news about blood clots and other scare mongering to make people want to use other vaccines?

Hanlon's razor. Never attribute to malice what can be explained by incompetence.

There's absolutely no evidence at all supporting your allegations.

Would that be a coincidence then that only vaccine made not for profit has such problems? Strange news coming? Allegations? I think this may be both incompetence and corruption. We'll see - I hope this will be properly investigated including the bureaucrats involved in the decisions and their financial affairs.

> there is money to be made under the table for bureaucrats

Corruption is by far not as bad here as in other places. See this [0] if you want to get an overview.

[0] https://en.wikipedia.org/wiki/Corruption_Perceptions_Index

This is just a report that collates the so called experts opinions and has no reflection in reality. I could create such report myself.

First world countries have just figured out that brown paper envelopes are gauche. Instead, you arrange a no-show job as a board member or consultant for a member of the politician's immediate family. All nice and squeaky clean!

Eh? No. Where did you get that? AZ's production shortfall isn't just an EU thing; it's general. The other manufacturers have no such issues; Pfizer-Biontec has actually been able to exceed promised production.

Pfizer seems to have a history of corruption - https://iclg.com/cdr/competition-and-business-crime/pfizer-p...

Keep in mind that AZ vaccine is not for profit so bureaucrats do not have many ways to make money from it and in their interest is pushing more expensive ones. This way you can explain the wave of fake news about blood clots and individual countries stopping vaccinations with AZ and scaring the public.

The AZ shot hasn't been approved in the US yet. They also released a study there where they're suspected of cherry-picking data to make it look good

https://www.niaid.nih.gov/news-events/niaid-statement-astraz...

just last week AZN told the UK gov to not expect large quantities due to manufacturing issues in their UK plants.

A lot of their problems seem to come down to the fact that they aren't experienced in vaccines so have made multiple missteps along the way because of that on the procedural side of things.

Their choice as partner for the Oxford vaccine was purely political. Merck were originally the preferred choice (and they have a lot of vaccine experience) and a deal was almost done, but the UK vetoed it because all production would be in the US and they wouldn't offer the guarantees the UK had gotten from Oxford as part of their funding of the Vaccine development.

https://www.theguardian.com/society/2021/jan/29/we-had-to-go...

If it was all in the US then none would have been exported to either UK or EU?

Seems like a good call.

Definitely. The EU had the same opportunity with BioNTech which was funded by Germany. But they allowed a partnership with Pfizer and now the US gets most of that production.

i think it’s due to the fact AZN isn’t a traditional vaccine producer.

what’s most striking to me is the complete silence (till recently) of the big 3 vaccine manufacturers: gsk, merck and sanofi. no vaccines from the biggest producers?

an interesting article that i found about this strange situation: https://www.google.co.uk/amp/s/amp.ft.com/content/657b123a-7...

I heard merck is partnered with J&J to help make their vaccine.

yes, after the Biden admin made a push. otherwise i don't think they would have gotten involved imo.

Merck was the Oxford team's first choice of manufacturer. But the UK health minister overruled and told them they needed to use a British manufacturer. [1]

"[T]he Oxford-AstraZeneca vaccine was very nearly the Oxford-Merck vaccine - and under the terms of the agreement with the American pharmaceutical giant, there were no guarantees of supply.

The episode played out against the backdrop of the first phase of the pandemic. During March and April 2020, the University of Oxford negotiated a deal which would allow Merck to manufacture and distribute the vaccine it was in the process of developing.

The arrangement made sense. Unlike British-Swedish AstraZeneca, Merck had experience in making vaccines. Its senior executives had links to Oxford scientist and government adviser Sir John Bell.

Yet when the contract reached Matt Hancock's desk, the former adviser said, the health secretary refused to approve it, because it didn't include provisions specifically committing to supply the UK first."

[1] https://news.sky.com/story/covid-19-rejected-contracts-and-a...

then why not use gsk?

Not sure ... but didn't GSK partner with Sanofi on a vaccine that didn't work out? Sorry, I can't read your FT link :)

they partenerd with Sanofi, but that vaccine failed. so they moved to providing an "“adjuvant” — an ingredient that can be added to vaccines to boost immune response — to several vaccine makers"

I've not been following AZ more closely than knowing why vaccinations in my country are delayed. What are the weird problems and events you speak of?

Overselling their production capacity by a lot, for one. The major protocol violations in their trials and the weird way they are handling it, are another.

There was no production capacity 12 months ago. EU suppliers failed to upgrade and improve yields sufficiently in time. The UK/US started expanding right at the start of the pandemic, so effectively had a 6-8 month head start.

Easy to say but not necessarily true. Let's look at the Halix factory, which is the main point of contention in the EU/UK dispute. The Dutch government (thus, EU) already offered them a major contract in March/April '20, for precisely this purpose. They already had started expanding in Feb '20 as part of their production for the AZ trial, so they declined.

> Overselling their production capacity by a lot, for one.

They grow live virus in live cell cultures. Scaling bioreactors from 50 liter test reactors to 1000 or 2000 liter production size reactors can be tricky. Even when everything goes well, bioreactors can have 3-fold differences in yield.

I would assume either AZ quoted the ideal production capacity. Or maybe AZ quoted a range, and EU politicians took the maximum of the range and believed that would be achievable.

> Scaling bioreactors from 50 liter test reactors to 1000 or 2000 liter production size reactors can be tricky

Yes, especially if you've never done vaccine production before!

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