How AstraZeneca threw away its shot | Hacker News Reader

How AstraZeneca threw away its shot

politico.eu

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> One of the most damaging moments was when French President Emmanuel Macron openly disparaged the jab in January, calling it quasi-ineffective.

What do you want people to say when you report a 6.3% efficacy (against serious illness in over 65's) in a phase 3 clinical trial? Sure it was a small sample and thus statistically useless blah blah, but design your trials better.

I never heard of a 6.3% figure for efficacy in any sample, small or otherwise. Are you sure that's what your figure refers to?

If I remember this correctly, that age group had so few cases that the error bars essentially covered most of the entire possible range. So even if you have a value like 6.3% this might actually be something like 6.3% +- 60%. And it that case the single value is extremely misleading, the true result is "we don't know".

I'm not sure I'm remembering the right case here, this happened more than once e.g. with some data from South Africa where low values were quotes without explaining that the studies simply were not large enough to get useful numbers for these subgroups.

That is the efficacy results from the AZ phase 3 clinical trial, in the over 65 group as published by AZ.

I can sense your doubt ... we can even go to the factcheckers to see it. https://fullfact.org/health/german-astrazeneca-8-percent-han...

Robert Koch Institute (RKI), including its calculations on the vaccine’s efficacy data submitted by the manufacturers. These appeared to show the vaccine was just 6.3% effective among over 65s.

The next sentence right after the one you chose to quote in your last paragraph: "This is close to 8%. However this number shouldn’t be taken at face value."

Why? TLDR: Too small group and too few cases in groups (one each) to be statistical significant.

Yeah the 8% was circulating in the media as the efficacy and thus this was debunking it as not the efficacy.

I said at the start not statistically significant. That is becuase they designed a shitty trial, if you are going to have an insignificant number of 65+'s in the trial, then dont make the target endpoint 'the number of cases' then when reporting a low efficacy are shocked when people took it on face value and ignored the p-value. If you want to test for side effects / will it kill people then make that the endpoint for that section of the trial.

That is horrifically bad science and communication. But if you publish a headline number of 70% efficacy in under 65's and 6.3% efficacy in over 65's what are you meant to think? That is might be quasi-ineffective in over 65s?

Thanks! I don't speak German but it looks like there were 341 who took the vaccine, 319 who took the placebo and 1 who got sick in each of those groups. Solve for e in (1 - e) * (1 / 319) = 1 /341 and you get 6.5%. Almost...

I feel bad for the Oxford people.

Don't, and they also shouldn't. I just got my first AZ shot last Friday, as many others did, and we are all much better off with it. No matter what, you can't understate the amount of good this vaccine did throughout the world.

The £20mil personal earnings from it will surely cushion the blow for them.

Way to spin the article. This has literally barely to do with the EU

> South Africa itself decided not to use the vaccine and infamously sold its doses to other African nations.

Yes, because efficiency results showed it is barely efficient against the South African variant (not sure which letter it is) - the lack of efficiency is apparently not a concern with other variants. But why should SA buy an ineffective (for them) vaccine?

AZ conducted the Phase 3 tests. AZ "is responsible" for the serious adverse effects (not blaming them - it is most likely due to poor application method and the vaccine getting into the bloodstream) and now that the adverse effects are known it's easier to treat it correctly.

That being said it fills its role of being an effective vaccine. If your area is not concerned with the SA variant I wouldn't worry about taking it.

> AZ "is responsible" for the serious adverse effects (not blaming them - it is most likely due to poor application method and the vaccine getting into the bloodstream)

The AZ vaccine has been reported to contain protein impurities: https://www.chemistryworld.com/news/protein-impurities-found...

Although no causal link to adverse effects has been established yet.

https://www.biorxiv.org/content/10.1101/2021.06.29.450356v1 (caveat: preprint)

> the adverse effects are known it's easier to treat it correctly

All the vaccines have some issues - ignoring them and sweeping them under the rug is reckless. RNA vaccines have risk of serious alergic reaction, can be mitigated by sitting for 15 minutes after the jab, monitoring and having epi pens on hand. Simple and effective and saves lives.

The article is sligthly better than the headline, but still I don't think it if fair to blame the EU for this. And one part the article doesn't mention is that limiting the use of AZ in younger people wasn't just decided by politics, in many countries this was done by independent scientific bodies.

There were a bunch of times were communication was bad, and I'd blame individual politicians here as well as some parts of the media. But this is also a fundamentally difficult thing to convey, the vaccine is not bad and far better than no vaccine for people above a certain age. But it has certain rare and serious side effects, and at lower ages the cost/benefit calculation for the AZ vaccine is not really in favor of it.

I don't think there is anyone to blame if people chose a vaccine with fewer serious side effects if they have access to it.

And all the talk didn't prevent people from still getting the AZ vaccine at a time vaccines were scarce, even if you're in an age group where it wasn't recommended. I got the first dose AZ myself, and I'm outside the age group it is recommended for in Germany.

I had two choices - AZ in Feb or wait till May for Pfizer. It was a simple choice, get AZ.

I expect I will take a 'top up' of Pfizer before the winter.

This is a bad faith article that would have ended the same either way. Right now western countries are getting taken to task for not approving the vaccine quick enough. Had they approved it quickly in spite of the blood clot concerns, the headline would be something like, "Wealthy Western Countries use Africa to test questionable vaccine" and there would have been references to Tuskegee and some such.

Everyone is in unknown territory with this pandemic and frequent judgment calls have to be made before all the evidence is in. Sometimes you get it right and sometimes you don't. But saying countries "ruined" an entire continent's chance out of the pandemic is blatantly dishonest reporting.

This. Besides most vaccines were to reach Africa from India. And the reason they didn’t is the devastating second wave in the country. Had India not had their wave, Africa would be much further along. US approval has no bearing here.

The reality is every country preferred and promoted shots made in their own country/region. One can write a similar article that India not approving US vaccines and not signing indemnity in favour of AZ shots made at home signals that US vaccines are inferior because of heart inflammation concerns.

Yes. Europe developed vaccines and gave some for free to Africans but somehow "the EU might have ruined Africa's best chance out of the pandemic". This is one more article in the thread of "White man bad" that are trendy since a few years. And the article doesn't enlighten us of what would have happened if UE didn't gave any vaccine whatsoever or let Africa develop one, since UE intervention supposedly f*cked up the situation.

> Even German Chancellor Angela Merkel and Italian Prime Minister Mario Draghi — who made a public show of getting the Oxford/AstraZeneca jab as their first shot to boost confidence — opted for an mRNA vaccine as their second dose.

This is a classic example of putting a "spin" on a certain information. I'm not aware of the situation in Italy, but in Germany the current official recommendation is for everyone who got a first dose of AstraZeneca to get an mRNA shot (either Biontech/Pfizer or Moderna) as the second dose to increase the efficacy. So Merkel is not "opting" for anything personally, just following the recommendation...

> So Merkel is not "opting" for anything personally, just following the recommendation...

While this is true, it looks entirely different when looking into the whole context of the vaccination campaign. I am a student in Germany and like many others currently enrolled in universities or for those still in school, politics didn't seem to care at all about us. The official STIKO recommendation nowadays (after they changed it twice) is that it should only be given to people older than 60 (or after consultation with ones general practitioner and if he agrees; in my experience, most don't for young patients).

After young people got (imho rightfully) outraged by a variety of factors, Minister of Health Jens Spahn suggested that young people who did not have the possibility to get an mRNA shot at the time, should get vaccinated with the AstraZeneca vaccine on their own risk and against the official STIKO recommendation.

So taking into account that government officials recommended millions of young people to get the vaccine at their own risk, Merkel (and others!) just "following STIKO guidelines" seems like a weak justification.

Many consider the changes in vaccine recommendation by the STIKO (german panel for vaccine recommendation) as a bad thing. Personally, I like that they are changing their opinion based on new data - what else should they do? Are you suggesting Merkel should have taken a second dose of AstraZeneca?

I'm not saying that the change of direction by the STIKO is a bad thing - new data leads to new conclusions and that they're openly admitting that with a change in their recommendation is very good.

Nonetheless, the whole communication during the vaccination campaign, especially regarding the AZ vaccine and the change in direction, went really bad and to me, its no surprise that the acceptance of the AZ vaccine went downhill

So they should have hidden the lack of testing in older population and furthermore hidden any potentially fatal complications?

I would have understood that outrage a few weeks ago, but at the moment it looks like the times of vaccine scarcity are over (in Germany and probably most other EU countries at least), so anyone willing to get vaccinated will be able to get the vaccine of their choice.

But yeah, I can sympathize - I'm over 40, but still in the lowest vaccination priority group, and was also left wondering when my turn to get a vaccine would finally come, while the press was hyping "vaccine scarcity" - my turn came faster than I had expected BTW. Now, in only a few weeks, they have gone from that to hand-wringing about "vaccine skepticism" and what can be done to get more people vaccinated.

So western countries should have pretended that adenovirus vaccines are on par with mRNA vaccines such that people in Africa would have been more willing to use it?

On par in what what? Should someone expect them to be less effective as a first shot? If done two has a different vector, what makes the two shots less effective? Would a AZ followed by a JJ work as well as two mrna?

Theres a certain level of "we dont have data to prove it" but that isnt the same thing as "we expect this to be less effective."

If the specific protein creates less immunity, or towards a variant, they do have time to modify it as well. There is a difference between the technology being inferior, and this implementation being inferior.

It's bad faith to downplay the benefits of viral vector shots, with regard to logistics and handling.

The white man's burden is a heavy one...

Really, sometimes I wonder if Pfizer is paying journalists to publish this kind of FUD article.

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