Doubts about Oxford Vaccine Data

[IslandGyal]

• NOT AN ANTI VAXXER

www.nytimes.com/2020/11/25/business/coronavirus-vaccine-astrazeneca-oxford.html

This article is concerning that there are several flaws with the Oxford vaccine research and data.

I think media need to look at this, ignoring the vaccine nationalism about this being a ‘British’ vaccine. It’s obviously effective to some extent but it seems that Pfizer and Moderna data is more robust and solid.

It doesn't surprise me, from what I can make out the DM are anti lockdown. Anti lockdown mentality tends to align with vaccines "not being a silver bullet". Principally I suspect because if the vaccine is only weeks/months away then the idea that we should open up more is harder to make out.

Objectively, we have a prospective vaccine that had 62% efficacy.

We have two others with 90%+ efficacy.

And then the Sinopharma (?) one which is already being delivered in MeNA

And then J&J and other vaccines being developed in Russia, India etc.

It doesn’t matter which country ‘leads’, no reason to mix nationalism with science. It’s a global problem and the solution mix may come from anywhere in the world

What the DM says is really irrelevant

J&J may be a dark horse (only one dose needed).

@Trut

What the DM says is really irrelevant

Cheers to this

Let's see what educated peers say about the data they are given first. Personally I hope they don't take the vaccines away from us.

I can't see any self-respecting research lab anywhere releasing a statement saying "we think this works" with the whole world watching if they think it doesn't work. Just can't see it.

Apologies for polluting thread with references to DFail . But you cannot underestimate how much popularist thinking is overriding science and intelligence in the country right now.
The government have a self-interest in keeping up with what these people think, directing it, manipulating and decision-making on the basis of it.
Hopefully the government have no leaning on the medicine's regulator.

😃 I agree that this is being whipped into a nationalistic pride thing. And at the same time trying to question science to advocate a particular ideological stance.

In the Guardian article on the Oxford vaccine they had an interesting link to an investor note

"We believe that this product will never be licensed in the U.S. This belief is based on the design of the company’s pivotal trials (which does not appear to match the FDA’s requirements for representation of minorities, severe cases, previously infected individuals and elderly and other increase risk populations), and based on the occurrence of severe safety events (why take the risk) that resulted in the extended clinical hold on enrollment into the trials in the U.S.," the analyst wrote.

Shares in the Big Pharma were off nearly 1.5% in London trading Monday morning, showing just how high the bar for a COVID-19 vaccine now is and how complex the picture for its efficacy remains.“

Does anyone know what this is “based on the occurrence of severe safety events (why take the risk) that resulted in the extended clinical hold on enrollment into the trials in the U.S.," ? What safety events are they referring to?

An event in a clinical trial is any medical event that occurs during treatment in a clinical trial, although it does not necessarily have a relationship to the study drug/vaccine - but the investigators have to give their assessment as to what the relationship maybe, but the final decision will be adjudicated by experts. A serious event has a serious outcome, such as hospitalisation, disability, death etc.

And I have a feeling they are going to have to run the half dose/full dose regimen as a substantial amendment. In a clinical trial you can't just change the dose, even if it turns out that the mistake dose is more effective - a dose change is always a substantial amendment that has to go back to the ethics committee, maybe the competent authority, for approval. Only once the dose change is approved can the dose change be implemented in the trial.

The hold on enrolment just means that the trial had to be put on hold while independent experts assessed whether there was relationship between the serious events and the study drug/vaccine.

Thanks itwill. What is the history here, would you know by any chance? Did they try to trial in the USA, which I presume would be helpful (needed?) for FDA approval?

I’m interested in the European regulators attitude to the Oxford vaccine. If they green light it I’ll have more confidence. I fear chauvinism and heavy pre-investment in it (it’s the only one being manufactured here I think?) may skew decision-making.

I also think the J&J vaccine might be a dark horse. One shot, relatively cheap, and with a rigorous trial design.

Although the US version is one shot, the J&J vaccine trial here is using two shots. It sounds like they might have decided two likely gives better results.

www.bmj.com/content/371/bmj.m4451

@ForBlueSkies

I’m interested in the European regulators attitude to the Oxford vaccine. If they green light it I’ll have more confidence. I fear chauvinism and heavy pre-investment in it (it’s the only one being manufactured here I think?) may skew decision-making.

I also think the J&J vaccine might be a dark horse. One shot, relatively cheap, and with a rigorous trial design.

Exactly. I think we can rely on EMA in this context.

Ironically, the UK government is still bound by the EU regulation regarding clinical trials, and so dose changes would be an amendment and the usual process for serious adverse events would have to be followed etc. And I believe that in order for the UK not to be entirely law-free on Jan1st, all EU legislation has to be enacted in to UK law anyway. Plus the EU Regulation on clinical trials is pretty standard clinical trial practice, anything different would be unethical and unprofessional, so the UK would be crazy to deviate.

Anyone know when EMA decides?

Actually clinical trials are pretty covered internationally by ICH GCP (good practice guideline) so the UK's mutterings a few months ago about changing the law on medicines regulation in this country is pretty much meaningless hot air.

No one can have a real view about any of the vaccines until the papers are published and/or all the details have been given to the regulators. Until then, the little news we do have looks all good.

@Trut

Thanks itwill. What is the history here, would you know by any chance? Did they try to trial in the USA, which I presume would be helpful (needed?) for FDA approval?

Mostly being manufactured in India I think since our domestic vaccine manufacturing megaplant won't be finished for a while.

@notevenat20

No one can have a real view about any of the vaccines until the papers are published and/or all the details have been given to the regulators. Until then, the little news we do have looks all good.

I really hope it is good news. Fingers crossed.

People on here are making it sound like the dosing issue was just picked up. Actually it was a manufacturing issue that was discovered early, many months ago, and reported to the regulators at the time who reviewed it and agreed that the trial could proceed using both doseages. Hence why it is unlikely to affect review or approval here - it was already noted and known.

www.bbc.co.uk/news/health-55086927

@MarcelineMissouri - thanks! sorry for making it sound like anything. Back to hopeful watchful waiting...

[quote MarcelineMissouri]People on here are making it sound like the dosing issue was just picked up. Actually it was a manufacturing issue that was discovered early, many months ago, and reported to the regulators at the time who reviewed it and agreed that the trial could proceed using both doseages. Hence why it is unlikely to affect review or approval here - it was already noted and known.

www.bbc.co.uk/news/health-55086927[/quote]
This

@Sunshinegirl82

I'm not interested in PR missteps, I don't really care about the press release, no decision is going to be based on it. I'm interested in how well the vaccine works overall in the context of its stability at room temperature and consequently its accessibility and until the peer reviewed data is out that question can't be answered.

This

There is plenty of chauvinism from Russia and the U.S etc with their vaccines.

Lots of the commentators on this are talking about it through a financial lens. Is that relevant to the safety and efficacy?

Also lots of media is quoting the head of US's warp speed. Not the FDA. Of course the FDA might not approve AZ vaccine. Will that matter? Not necessarily.

Interesting to see what Gavi says:-

www.gavi.org/vaccineswork/why-oxford-astrazeneca-vaccine-now-global-game-changer