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

[ForChristsSake]

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

I'm based in EU myself

@Haffiana

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.

So @Cotti is trying to call blinding a fudge? 😂

@Thewithesarehere

www.bmj.com/content/371/bmj.m4777

You've got the wrong end of the stick completely @Thewithesarehere . They used meningococcal conjugate vaccine or saline both as controls.

@Haffiana

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.

Thank you for this.

We’re not the ‘only ones’. We’re the first, which is something different.

Dr Raine explained yesterday that the MHRA have been doing a process of ‘rolling authorisation’ in which they have been working with the Oxford / AZ teams throughout the clinical trials process, assessing the data & results of the trials as they went along.

This is why the vaccines have been developed so fast, as has been explained numerous times. The various stages of the design, trial, analysis, authorisation, manufacturing, distribution etc etc have been done in parallel, not sequentially.

@Cotti That isn't a peer reviewed article, it's not the data itself either - it's a news report. They took appropriate experimental measures when the error was discovered. Here is the Lancet paper.

@Cotti

You've got the wrong end of the stick completely *@Thewithesarehere* . They used meningococcal conjugate vaccine or saline both as controls.

But that is the whole point of blinding.

@Thewithesarehere Right, so ALL the control patients should have had either saline OR the menegitis jab not a mix a both. They are no longer a control group because the subjects received two different treatments. The investigative group all received the jab but some got a different dose than the others. This is what makes it a hot mess. To be a well controlled study ALL control subjects needed to have the same treatment and ALL investigative subjects should have received the same dose of the covid vaccine. This violates the very basics of trial design.

@sergeilavrov The FDA disagrees and hence why they have asked for more data. There is nothing to be done except to add patients to the trial. They will only accept those subjects who had the proper dose.

[quote Cotti]@Thewithesarehere Right, so ALL the control patients should have had either saline OR the menegitis jab not a mix a both. They are no longer a control group because the subjects received two different treatments. The investigative group all received the jab but some got a different dose than the others. This is what makes it a hot mess. To be a well controlled study ALL control subjects needed to have the same treatment and ALL investigative subjects should have received the same dose of the covid vaccine. This violates the very basics of trial design. [/quote]
No. Wrong.

Don’t the FDA want more data for the reason of more ethnic groups and older people. Personally if I were in an ethnic group or older category I would be wanting them to be approving the vaccine quicker before I caught Covid.

India is supposedly going to approve the Oxford vaccine today.

@Haffiana How is this wrong?

@IcedPurple

India is supposedly going to approve the Oxford vaccine today.

Yes, they have just done so. mobile.twitter.com/chandrarsrikant/status/1344983359487840256