The Corona Pandemic

WHO is not currently working. A large part of that is due to the vaccine production issues that nearly all Pharma companies are dealing with. Another part is that the funding of COVAX has been too slow. The Trump Administration refused to take part initially and the US only came on board this year following the change in administration.

However, the ramping up of vaccine production is taking place. 100s of millions of vaccines are being produced and made available through the COVAX scheme for countries that would otherwise have no chance whatsoever of either developing or procuring vaccines in those numbers. It needs to improve substantially (and it will) but it’s much better than it would be without it.

No, the UK is not refusing to export vaccines or vaccine components. Pharma companies are responsible for exports (unless there is a government imposed ban, such as in the US or export measures such as the EU have set up) and all Pharma companies based in the UK are fulfilling their orders.

It is not the same as there is no UK ban on exporting vaccines or vaccine components. The EU have already banned at least one shipment to Australia and refused direct pleas to allow the lawful export of much needed vaccines to Papua New Guinea.

The EU is making a choice. The EU is not producing these vaccines or exporting them, companies based in the EU are. Lives will be (and are being) sacrificed by the EU banning the export of certain vaccines lawfully ordered by other countries. It is now choosing to say that European lives are more valuable and that vaccines lawfully ordered from Pharma companies based within the EU should be sequestered and diverted, unlawfully, to the EU.

The UK is not doing this, at all. On the contrary, the only reason that AZ is able to produce in the volumes it currently is, is a consequence of the prior agreement with the UK. The UK has also ensured that the Oxford vaccine has been licensed around the world for production and distribution, at cost. It has ensured that the IP is exported, for no profit, so that manufacturing can take place on a mass scale and in as many places as possible.

Again you are suggesting that speed implies recklessness or insufficient scrutiny. This is simply not the case. The same mechanism would be available to EU member states - I would be surprised if the EU would legislate for something that would be so potentially reckless. It also misunderstands how the MHRA was able to approve AZ and Pfizer quicker than the EMA. It worked alongside these companies, was effectively updated in real time, it meant that it was not looking at a whole load of data in one go when it came to final approval but was effectively reviewing the data it had already had oversight of for months. That makes the process no less safe but a whole lot faster. The EMA had the same data to work with when it too approved AZ for use.

The EMA has approved the Janssen vaccine for use ahead of the MHRA. Does that mean it’s been reckless and that Janssen has not been subject to sufficient scrutiny? Of course not.

It’s worth bearing in mind that the UK has a lot of expertise in regulatory approval. The EMA was, after all, based in the UK up until Brexit.

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They lead the world in getting their population vaccinated. On this side of the world we are vaccinating about 6000 a day, restrictions are at the lowest level, Easter is next weekend in an all but open society except for social distancing guidelines and mandatory mask wearing and we’re going to be heading into our winter.

Our third wave beginning is not a possibility but a rapidly becoming a certainty imho while unlike us and much of the rest of world Israel is doing an incredible job. If only we could squander in such a fashion.

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WHO chief: waive Covid vaccine patents to put world on ‘war footing’ | World news | The Guardian

At a guess, those that oppose the TRIPS waiver, namely the US, EU, UK, Australia that make up 14% of the world’s population account for, what, 98% of the world’s inoculations? :roll_eyes: Those fictional post-apocalyptic storylines of absolute selfishness are coming to pass.

Looking at that map, this could equally be in the Racism… thread.

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Isn’t this essentially a question for the individual pharmaceutical companies? AstraZeneca partnered with Oxford/UK on the understanding that their licence would be shared on a non-profit basis for the period of the pandemic. It was open for other vaccine developers to do so too, wasn’t it? I mean, isn’t that what sanofi have been asking for - the IP in Pfizer (or was it Moderna?) to be shared so that they too could help with the challenges of producing the vaccine in huge numbers, given that their own candidate had failed?

For the record - I also don’t like the UK receiving any AZ vaccine doses from the SII. They should leave the doses produced there alone. I’ve got no problem with the UK receiving the doses from Halix though, if that plant is contractually part of the UK supply chain (the UK helped set it up, after all).

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Yeah, this is bad. It’s obviously bad on its face, especially given the current uncertainty about the AZ vaccine. But it’s also important to appreciate how rare a public comment this is.

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Yeah. I’ve read how unusual this is although I’m not certain as to what the precise issue is - it’s unfortunate that the comment from NIAID has been so oblique. They should say precisely what the issue is, which may provide some sense of comfort. Right now it just looks like AZ is being shady (or being made to look shady). Either way, not great for confidence levels in the company or the vaccine.

These organisations need to be a lot more circumspect, it seems. Don’t announce findings or outcomes from regulatory approvals hastily. When it goes into the public domain for the first time make sure it’s right.

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If we use the US as a contrast, we have limited data on who has received the vaccine because of the non-centralized healthcare infrastructure we have (and partly because in lots of places it is in their political best interest to not be able to demonstrate that their not giving to black people). That means we’re not all collecting the same data in the same way, which limits our ability to make inferences on the real world effects.

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Ok, blimey. Suggestions that Merkel may have changed her mind at the last minute…

So in short, AZ were not given US approval on the basis of their EX-US studies alone, which is a fairly standard practice, and so we’re required to collect trial data from US subjects as part of their application here. People knew they had completed those trials and were awaiting results, and so AZ went public with results from an older, incomplete set of data. The DSMB, an independent group of experts whose job it is to monitor this, identified this and seemingly felt jerked around so responded.

AZ are now saying that while they haven’t completed the actual analysis of the full data set, their preliminary view of it is that it looks like it will say the same thing.

Honestly, they really aren’t doing themselves any favours at all throughout this whole process. Independent of a judgement on the safety and effectiveness of their vaccine, their conduct in conducting the trials has been sloppy as hell, sometimes exacerbated by lack of candor and transparency. And all this in an environment of very reasonable skepticism about the performance of these vaccines.

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Yes, that’s a good summary. Here’s AZ’s press release in response as a separate link:

https://www.astrazeneca.com/media-centre/press-releases/2021/update-following-statement-by-niaid-on-azd1222-us-phase-iii-trial-data.html

Basically, we saw that the trial data aligned with our earlier studies so announced the findings from our earlier study as indicative of the results to be published from the later trial.

Fuck me, they’ve made a pig’s ear of this. It was going much better for them in January/February when they were basically keeping their counsel.

In some respects, I feel really sorry for them. They’re absolutely desperate for their vaccine to be lauded given how much it’s been unfairly panned that they’ve gone too early on pre-empting the FDA announcement and now look like chancers. :man_facepalming:

But this isn’t a new thing - there were some concerns when they first started releasing data late last year wasn’t there.

Yes. Their handling of the dosing screw up was terrible.

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Yeah. I’m not saying it’s new - just that this is AZ’s first significant chance to finally have a major organisation publicly endorse its efficacy and they’ve jumped the gun, making them look like the chancers many will already perceive them to be. Uggh.

The ones you’re referring to are, I think, about the errors that occurred regarding half-doses etc. There were a couple of stupid mistakes made that placed question marks over their data and the robustness of their clinical trials. Real world efficacy has since proven the efficacy to be really good but they didn’t exactly have auspicious beginnings. I think there was also a concern early on when the trials needed to be suspended when there was a death in the trial group. It was subsequently shown not to be related to the vaccine but these little issues have dogged AZ.

Meanwhile, the other pharma companies must be delighted that AZ is taking so much of the spotlight away from them! Their own vaccines also have issues but these have not been the subject of so much publicity. The conspiracy theories will point out that those vaccines are profit-making and so its perhaps in the interests of some for AZ to be traduced…

But specifically, it’s why Pfizer isn’t been given to people with allergies due to one of its ingredients causing known issues. AZ is being recommended instead.

The Janssen/J&J vaccine is a similar Adenoviral vector-based vaccine isn’t it? Similar enough to be almost equivalent in the way the Moderna and Pfizer vaccines are? AZ and J&J have taken very different paths even when their effectiveness is within the same region (60-80%). I know comparisons between vaccination trial results is one of your pet hates because of the differences in the design and measures in the trial so I apologise for doing it! :laughing:.

My point is that J&J put together a more robust trial and didn’t move the goalposts. AZ didn’t need to try to ‘compete’ with the efficacy figures of the mRNA vaccines after it was gazumped in its phase III trial results by a week by Pfizer (the 90 % figure was rejected by the MHRA (Questions hang over UK's rollout of Oxford/AstraZeneca jab | Coronavirus | The Guardian). I am sure every expert in the field can see what a benefit a vaccine with modest storage requirements can have in the global rollout. That stands on its own. No need for confusing the results of the trial.

J&J included a large base of participants in the categories that scientists are interested most in: Those with co-morbidities (41%) and those in the elderly age group (34% 60+) according to their US FDA announcement in late Feb. I know Oxford limited participants in these categories on ethical grounds, but IMO that is a factor in some of the bad press it has received (lack of 65+ data in Europe). The J&J vaccine is a single dose vaccine and very similar in price, maybe even cheaper given only one dose needs administering. Those are all massive selling points. I have heard someone on here, maybe even yourself, say that different vaccine avenues ( mRNA, Adenovirus) could likely be a benefit when facing the variants of the future.
Hopefully the AZ vaccine can recover it’s image because we need every vaccine we can get.

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A couple of corrections:

Janssen is an adenoviral vaccine like AZ. Moderna and Pfizer are mRNA based vaccines. The AZ vaccine has since been shown to have more efficacy than Pfizer (when AZ uses a 12 week interval), not less (94% compared with 92% from memory). What do we now know about the effectiveness of the COVID-19 vaccines? | GPonline
AZ vaccine was also intended to be a single dose vaccine at the outset so the double-dose regimen seems to act more like a booster. It is already showing very good efficacy 2-3 weeks after first dose (over 75% again from memory).

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I mentionned the Sanofi vaccine and how fast they can and have managed to reformulate and now managed to get back to trails after the initial dissappointment. Once these types of vaccines get results (which i believe include J&J and AZ) they can quickly reformulate. I’m not sure that’s so easy with mRNA type vaccines (don’t forget Sanofi has a lot of knowlegde on this (flu vaccine for example)). Let’s just hope we don’t get to the situation where variants cause vaccines to become ineffective. I see Sanofi as a game changer once they get up and going due to their capacity to manufacture, cost and stroage making it more easily available to poorer countries.

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