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And now the bloody vaccine trial is paused due to a potential severe side effect

167 replies

Worriedmum999 · 09/09/2020 01:00

As if this week could get any worse. Cases up! Deaths up! Heading back to more restrictions and potentially lockdowns with the second wave.

I have had a really down few days. I’m vulnerable and scared of leaving my children without a mother. I’m scared that they are going to school and we can no longer shield. I’m scared of what more isolation will do to them.

I was pinning my hopes on the Oxford vaccine. Probably stupid I know. There has been no glimmer of light with this pandemic. Everything has gone wrong and turned to shit. Now it looks like we’ll have no vaccine in the near future. At least we were front of the queue for the Oxford one. If we have to wait for some from another country we could be in this hell for years...and that’s if any will even work.

So down tonight

OP posts:
raviolidreaming · 09/09/2020 09:53

The link has nothing to do with the vaccine trial, and I'm not sure how you can extrapolate from a 'long covid fb group' what symptoms from the vaccine trial are 🤷‍♀️

Cornettoninja · 09/09/2020 09:54

@keepdistance - sorry if I’ve missed it but whats that got to do with the vaccine?

Ylvamoon · 09/09/2020 10:00

Sorry, I haven't read the whole thread.
I just think this is published to demonstrate that everything is done by the book. And safety is taken seriously.
Nobody wants a vaccine that is rushed through by cutting corners. The public need to trust the vaccine once it becomes available (remember MMR?).
In the meantime, we just have to accept a life with corona.

Keepdistance · 09/09/2020 10:10

This reply has been deleted

Message withdrawn at poster's request.

Cornettoninja · 09/09/2020 10:12

@Keepdistance, sorry but I really don’t understand how you’re linking that article to the oxford vaccine? There’s no mention at all of it being a factor in that young girls illness.

I think you need to report your posts and ask MNHQ to delete them, that’s precisely how misinformation starts.

raviolidreaming · 09/09/2020 10:16

Cornettoninja - I agree entirely. The article has no link to covid-19 or the vaccine trial, and the previous post listing symptoms that apparently link vaccine unwanted effects with long term covid-19 effects is irresponsible with no supportive evidence.

Keepdistance · 09/09/2020 10:16

This reply has been deleted

Message withdrawn at poster's request.

raviolidreaming · 09/09/2020 10:20

Keepdistance That article is a case study of ONE person, and The Sun journos clearly couldn't readily find anyone who had transverse myelitis post-covid or suspected covid or vaccine or virus or they would have featured them in an article.

CrunchyCarrot · 09/09/2020 10:20

It's good they are taking this seriously and investigating, and it does pour cold water on conspiracy theorists' claims that anything like this would be hushed up.

foxychox · 09/09/2020 10:21

*foxychox

@MarcelineMissouri Yes.... But they really don't want to unblind themselves unnecessarily as it ruins the trial. So I was wondering exactly when they do it.
It would be unblinded to the review board and the regulatory authorities, AZ and the investigators (and of course the subjects) remain blinded.

The volunteer can be told if it is an important matter for their health and they need to know. It will not be kept from them.
But whether they can carry on with the trial once they know i am not sure*
They wouldn't

Keepdistance · 09/09/2020 10:21

It is not misinformation
I am not saying their vaccine is causing this. How would i know?
I am clearly saying it can be a (rare obviously!) consequence of actual covid anyway. And you can get it from any vax potentially or most viruses. (Which imo makes it less worrying as a vax consequence as it could be bad luck or unrelated even)

Cornettoninja · 09/09/2020 10:32

@Keepdistance

What the issue is is very interesting as it's symptoms are very similar to issues patients complaining of long covid have. Tingling Difficulty breathing Digestive issues.
Sorry @Keepdistance, this post onwards reads like this is linked to the reason they’ve halted the trial. In the context of this particular thread it’s really misleading since there hasn’t been any information at all released regarding the details of the patient.

That young girls story is awful and I’m very interested in the emerging details about the long term effects of covid but neither of those things have anything to do with the Oxford trial being halted.

bibbitybobbitycats · 09/09/2020 10:34

This is surely a normal part of the development of any drug and the reason there are trials in the first place - to pick up and iron out side effects (if this is one).

As a pp said, it at least puts paid to all the conspiracy theorists saying that a vaccine will be rushed through without proper precautions so we can all be chipped etc etc.

raviolidreaming · 09/09/2020 10:36

What Cornettoninja said from me too.

MadameBlobby · 09/09/2020 10:41

@TheAdventuresoftheWishingChair

To be fair, I don't think it's someone intentionally scaremongering, it's someone vulnerable having a panic. It's easily done. The media have been so good at whipping fear up and it's been so relentless it's easy to read things and assume the worst.
This. Most people don’t know about how vaccine trials work as they have never had to take the same level of interest in it as now. Not everything is “scaremongering”.
MadameBlobby · 09/09/2020 10:44

Is it definitely someone who had the vaccine who is ill or could it be someone who had the placebo? Sorry if that’s a ridiculous question.

notevenat20 · 09/09/2020 10:47

Is it definitely someone who had the vaccine who is ill or could it be someone who had the placebo? Sorry if that’s a ridiculous question.

I think we know it is someone who had the vaccine, otherwise they wouldn't have suspended the trial.

raviolidreaming · 09/09/2020 10:51

I think we know it is someone who had the vaccine, otherwise they wouldn't have suspended the trial

It would be suspended immediately, before they checked. They wouldn't wait to find out first! Also there is no placebo - the meningitis vaccine is being used as a control - so any effect could potentially be attributed to either vaccine and this would need to be taken into account.

noblegiraffe · 09/09/2020 11:00

The illness could be a perfectly normal case of D&V picked up from anywhere.

They don’t suspend trials for perfectly normal illnesses. It has to be a serious adverse event possibly linked to the drug being trialed. So death is a serious adverse event, but if the death was from a car accident, it wouldn’t affect the trial.

Clinical trials are run under the principles of the Declaration of Helsinki. This is human experimentation so they have to be careful.

Cornettoninja · 09/09/2020 11:02

@Keepdistance - fair play to you, thanks Flowers

Out of interest does anyone know approximately how many people are currently enrolled on the trial? (My google-fu is failing me!).

I’d be interested to know what perspective this single event should be viewed in. Obviously that doesn’t take away from the seriousness of it but I believe the phase 3 trials are quite far along and this would be one of two adverse events? What would be the acceptable rate for a vaccination to have?

Cinderellashoes · 09/09/2020 11:03

I used to work in research and this happened all the time especially with such a new drug. Most of the time it wasn’t even connected to the drug but all clinical trials are bound by the same safety regulations regardless if there’s a global pandemic. I think the OP is having a panic but there’s no need; the deaths aren’t really up (they are always highest on a Tuesday because of a weekend lag), cases are up but hospital admissions are not. Keep perspective.

Cinderellashoes · 09/09/2020 11:05

Oh and a serious adverse event can be one that requires hospitalisation so for example if one of the test subjects has developed sepsis/meningitis/literally any other illness you can think of and needs hospitalisation (even if only for half a day!!!) this counts as a serious adverse event

Cornettoninja · 09/09/2020 11:11

@Keepdistance - the BBC is reporting that the New York Times has reported transverse myelitis (like you posted) has been rumoured to be the cause of the halting of the trial.

It’s still not confirmed and a bit Chinese whispers but it does link back to what you posted originally.

www.google.com/amp/s/www.bbc.com/news/amp/world-54082192

Qasd · 09/09/2020 11:22

I think this was the problem it was always a trail and it may fail many do. There really has been too much talk re “when will the oxford vaccine be ready” rather than “will the oxford Vaccine work”...which was always the right question.

This may be a blip but it may be that alas this isn’t the right vaccine..the team will go away, look again and deal with issues but it’s why we have never before managed a vaccine approval in less than four years.

TheKeatingFive · 09/09/2020 11:25

This may be a blip but it may be that alas this isn’t the right vaccine..the team will go away, look again and deal with issues but it’s why we have never before managed a vaccine approval in less than four years.

We’ve never had a pipeline that looks like this either.

If this one fails, there are plenty of others coming up behind it.