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How come the UK are the only ones to approve the Oxford vaccine

64 replies

ForChristsSake · 31/12/2020 19:38

Just wondering why the EU & USA aren't approving any time soon.

I'm based in EU myself

OP posts:
OchonAgusOchonO · 31/12/2020 20:29

This group, however, did not include adults over 55 years old as the low dose was given in an early stage of the trial, before older adults were recruited.

This difference could hugely distort the efficacy figures. Older adults may have a less robust response to a vaccine so only using younger adults may boost the efficacy figures.

AlexaShutUp · 31/12/2020 20:29

The Indian media were reporting yesterday that India is planning to use the AZ/Oxford vaccine. Cost and ease of storage seemed to be the main factors.

FourTeaFallOut · 31/12/2020 20:31

But we are not using a half dose - full dose regimen.

Fortherosesjoni70 · 31/12/2020 20:32

@BigRedDuck

It's the price per dose.
It is clearly stated many times and specifically on DR John campbell [doctor on you tube] that it is non profit.
Em777 · 31/12/2020 20:33

American explanation here:

www.politico.com/news/2020/12/30/astrazeneca-vaccine-april-452371

MarshaBradyo · 31/12/2020 20:33

People said the same about Pfizer one. Same panic over being first and wrong.

Turned out to be incorrect.

Bacter · 31/12/2020 20:38

This reply has been deleted

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IcedPurple · 31/12/2020 20:39

I believe Argentina has also approved it.

whatswithtodaytoday · 31/12/2020 20:40

The EU didn't meet to discuss the data until much later than us - only last week.

Soooh · 31/12/2020 20:42

Because our regulators are ahead of the game and hence quicker. Why is that so difficult for people to accept.

The Oxford vaccine is based on known vector technology. Injecting a weak form of the virus that is not able to replicate in humans so stimulating antibody response. The Pfizer and Moderna vaccines are based on novel mRNA technology. The efficacy of the Oxford vaccine is 60-90% of people dont develop any symptoms at all. But 100% of people dont develop serious disease or need hospitalisation. That is after ONE dose. (Not the same for Pfizer btw - there you need both doses). And 100% no hospitalisation after one dose is ENOUGH. Plus it can be rolled out not for profit. Without deep freezing. So can be used in developing countries.

Watch as other countries eventually sign it off.

sergeilavrov · 31/12/2020 20:42

I sat in a very dull meeting about this before Christmas and this is what I remember. Essentially, the UK are quicker to authorise vaccines because they work with firms early and are willing to pay in advance. The processes are really well worked out, not sure why other countries aren't so organized. Moderna vaccines take longer to manufacture, and the firm has limited supply lines beyond the US, which poses issues because they capped the amount you could pre-order prior to approval meaning states ordered 5m max (UK got 7m, so I assume more money was paid) and then has to bid again for more doses. It caused a lot of frustration for a number of governments who missed a trick with the Pfizer preorder e.g. EU. Ultimately, we don't like big business but they're much more efficient and effective at this sort of thing. It caused a lot of friction between the UK and US/EU who were slower off the mark. The same happened with PPE purchasing when the UK bought so much of it, it meant other governments were unable to get any.

There are also some differences between efficacy, hence the order in which they are delivered is important and to which groups. Pfizer is at 95%; so frontline workers likely to spread, and in significant demand as well as elderly who are most likely to have mortality concerns get the 20 million vaccines we have from them. We have 3.5m vaccines from Moderna, which is 94.1% effective - but slightly less in elderly people. So this is great for later groups. AstraZeneca offers 90%, but requires a long waiting period between doses which means people are at risk between those times - thus this should be used for people able to live independently for some time, working from home etc.

AstraZeneca is the one we are purchasing for impoverished countries due to the easy storage and low cost. It's going to be the one that sells the most. Meanwhile, I had the Sinopharm vaccine a few months ago. That's at 79% efficacy in one trial and 86 in the one I was in, but have since had the Pfizer vaccine too. Problems may come as countries double dip and vaccinate people twice after having first used less effective options on critical personnel resulting in global shortages. There is also a Russian vaccine, Sputnik V, but unlike the Chinese they won't allow independently manufactured trials so no one trusts the 92% effectiveness data.

Also -- while I remember, not all countries have independent approval processes. Many piggyback on decisions made by the US or UK. So when we buy vaccines for countries e.g. Yemen, basically there is no 'approval' process at all.

TonMoulin · 31/12/2020 20:42

What @Cotti said.

The vaccine might be great. But the trial was rubbish and can’t actually confirm its worth the paper it’s written on.

And tbh, the mistake with the dosage wasn’t great. But using two different placebo isn’t excusable in my books. It’s saying that the whole design of the trial was lacking professionalism

Soooh · 31/12/2020 20:43

@IcedPurple correct they have. Plus some other countries. And India will follow soon.

Soooh · 31/12/2020 20:43

@TonMoulin Jesus Christ. Seriously?

FeelingBIue · 31/12/2020 20:43

@OchonAgusOchonO

The EU are asking for more data before approving. Presumably they feel the data is insufficient to approve it yet.
According to this article AstraZeneca haven't even filed an application for an EU licence yet. Hardly surprising the EU aren't ready to approve something that hasn't been applied for!

www.pharmaceutical-technology.com/news/astrazeneca-oxford-vaccine-eu/

LadyBishyBarnaby · 31/12/2020 20:44

The FDA and EU also vary in their approach to assessment - I have seen drugs approved in the US that find it impossible to again approval in the EU and vice versa.

Whilst the UK is no longer in the EU, the MHRA will generally still be following the same assessment criteria, as its assessors will up until now have been working with/for the EMA, as the EMA doesn’t have its own assessors and assessments are done on its behalf by assessors from the national agencies. Until Brexit, the MHRA had a leading/influential role working with the EMA and writing a lot of the EU guidance - so much for “taking back control”.

Bacter · 31/12/2020 20:44

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misscockerspaniel · 31/12/2020 20:45

www.itv.com/news/2020-11-27/worlds-leading-vaccine-producer-says-uk-will-be-first-to-get-new-covid-jab

This interview answers a few questions and gave me so much hope when it was aired last month.

SirGawain · 31/12/2020 20:49

@Cotti

Because it was the worst run trial anyone has seen for decades! The quality of the data is shocking and with viable alternatives why would they? Only fools would take that vaccine. Or ya know desperate people on an island with a regulatory body that got strong armed by the government because they didn't order enough of the vaccine with actual data.
You have omitted to include details of your medical/scientific qualifications which entitle you to make this sweeping generalisation. As a leading academic in the field you will realise the importance of providing full references for any claims made!

Unless as I suspect you are simply a fully qualified FaceBook expert. Biscuit.

FourTeaFallOut · 31/12/2020 20:50

The EU weren't intending to approve the Pfizer vaccine until the 29th December till Angela cracked the whip and then it was approved on the 21st. But, that's ok. Was it rushed through or were they being lazy? Either way, I'm sure we are the ones in the wrong Hmm

Cotti · 31/12/2020 21:00

@SirGawain I'm not linking to my LinkedIn thanks. I don't need to. Anyone with an iota of knowledge of clinical trials knows this wasn't well controlled. They used TWO different controls. They have included the protocol deviations (the dosing fuck ups) in the Intent to treat analysis. Tell me how that doesn't make for one monumentally fucked trial? Please. Educate me.

Haffiana · 31/12/2020 21:00

But using two different placebo isn’t excusable in my books. It’s saying that the whole design of the trial was lacking professionalism

I will explain, and then you can choose to carry on believing whatever you want for your 'books' but unlike now, you will be no longer be ignorant.

When you inject someone with saline, there is no reaction at the injection site. When you inject someone with a vaccine there is usually if not always, swelling and redness.

Therefore those receiving placebo can make a reasoned guess that they did not get the vaccine, and this negates the entire purpose of a double blind trial. Therefore in one group of those not receiving the vaccine, they instead injected a vaccine that prevents meningitis and which causes the usual redness and mild swelling at the injection site.

This group was therefore acting as a control to measure the possible effects of those receiving saline who worked out that they were not vaccinated and who as a direct result, could behave differently over the term of the trial.

OchonAgusOchonO · 31/12/2020 21:01

@FeelingBIue - According to this article AstraZeneca haven't even filed an application for an EU licence yet. Hardly surprising the EU aren't ready to approve something that hasn't been applied for!

Normally, that would be the case. However, the EU (and other regulatory bodies) are taking a rolling review approach whereby the data is reviewed as it becomes available and then, once there is sufficient data, the company can apply for approval.

According to your link: Once the CHMP decides that sufficient data are available, the formal application should be submitted by the company.

So they can't apply for approval until the CHMP determine sufficient data is available. Apparently, additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation and this has been requested from the company.

Thewithesarehere · 31/12/2020 21:04

@TonMoulin

What *@Cotti* said.

The vaccine might be great. But the trial was rubbish and can’t actually confirm its worth the paper it’s written on.

And tbh, the mistake with the dosage wasn’t great. But using two different placebo isn’t excusable in my books. It’s saying that the whole design of the trial was lacking professionalism

Where is the reference for this? Even with two ‘placebos’, the number of trial participants is more than sufficiently high. So unless you mean that the placebo meant another vaccine (which vaccine?) and saline interchangeably and without tracking (I find it next to impossible but if you have a reference, please share!), enough data should be available. I need to see peer reviewed paper. Does anyone know if it has come out or not yet? I think it hasn’t probably.
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