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Original poster

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:
notevenat20 · 09/09/2020 07:39

Apologies if someone has already answered this but do they check if the ill person in the trial received the placebo or not?

MarcelineMissouri · 09/09/2020 08:04

I would think that would be the first thing they’d check @notevenat20! Because if they had the placebo then panic over!

notevenat20 · 09/09/2020 08:07

@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.

diplodocusinermine · 09/09/2020 08:10

This shows how seriously vaccine testing is undertaken in this country. No-one really knows if an illness was caused by the vaccine or by some totally unrelated cause but they are being thorough and suspending testing until they find out. This should be comforting - the vaccine is not going to be rolled out willy nilly until it is deemed absolutely safe.

RedToothBrush · 09/09/2020 08:17

Actually this should reassure you.

It demonstrates the trial is competent and isn't being pushed through without regards to side effects.

It ultimately only proves due diligence rather than the vaccine not being viable at this stage, pending further investigation.

It could be that this vaccine ends up a dead end, but the UK government have invested in the simultaneous development of several vaccines - this is not the only trial ongoing.

So dont panic.

StormzyinaTCup · 09/09/2020 08:26

Disappointing but quite often with vaccine trials it's two steps forward and then one back. I'm very grateful and have utmost respect for the people putting themselves forward for these trials and I hope this particular person make a full recovery.

foxychox · 09/09/2020 08:26

@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.

planningaheadtoday · 09/09/2020 08:29

I'm so glad you posted OP.

I'm in exactly the same scenario and with three children at different schools I'm pretty terrified.

If I get covid I've been warned by my GP that I'm high risk for serious complications.

I'm so angry with the government for this shambles. The risks would have been less overall if we had returned children to school in June on a part time basis and not had summer holidays. Yes there would have been gaps for breaks from teachers but overall they could have had a socially distanced, smaller bubble teaching environment.

The risks would have been less if the money thrown at eat out to help out had been invested in safer schools and a decent online blended platform.

The bubbles of 240 is a joke. I too was pinning my hopes of some normality on this vaccine.

Yesterday one of my teenagers missed the crammed bus. She had to miss school as I can't travel within two meters of my children so can't drive her. I can't even come within two meters of them our home.

Being a shielding parent is hideous. There is no safety, and I too do not want to leave my children without a mother.

But reading all the responses on here have helped. Helped put today's really bad news into perspective. So thank you all for this.

sashagabadon · 09/09/2020 08:30

They can unblind participants in these sort of situations. Even the researchers don't know how has placebo.
I am on trial and we alk carry cards with our number on with instructions to present this if we go to hospital for any reason. Our gp's also know we are on trial but not what jab we had.
I am not sure if a volunteer can carry on with trial once unblinded though. They have had jabs so maybe but they don't want the knowledge to affect behaviour

SebandAlice · 09/09/2020 08:31

Drug trials are usually 3 - 5 years. That is when I would feel comfortable taking a vaccine. Covid 19 would most likely be mild for me. I would rather that than a rushed vaccine.

sashagabadon · 09/09/2020 08:35

I agree with redtoorhbrush. This is reassuring news . All precuations are being taken.
It is a really well run trial and we should be confident in the way it is being developed ( whether it works is another matter, fingers crossed it does)

sashagabadon · 09/09/2020 08:39

[quote 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.[/quote]
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

Hereinthesticks · 09/09/2020 08:42

@sashagabadon yes individual participants can be unblinded, their cases will be reviewed and an assessment made of whether the side effect is related to the trial medication. That participant would then not receive further treatment but they continue to the monitored and followed-up.

Ellsbells12 · 09/09/2020 08:47

Thanks god I read this I am so so anxious today

Hereinthesticks · 09/09/2020 08:58

However, it is not just D&V in this case unfortunately, it is a serious event, which if the trial subject was given the real vaccine will probably take longer to deal with. However, it would still be regarded as isolated if only one subject out of tens of thousands developed it - hopefully.

ThatDamnScientist · 09/09/2020 09:04

Please dont worry (easier said than done, I know Flowers, especially coming out of shielding into this chaos).

The same happened to Moderna earlier on (The American drug company in phase 3 trials like oxford), all that happened was a dose size needed adjusting (they had 3 dose sizes being trialled at the same time) . Oxford will be back up and running soon, I'm sure of it. It is just a normal blip in vaccine trials.

BabyLlamaZen · 09/09/2020 09:04

Op I'm sorry Flowers but also I really don't think the vaccine is confern right now? This happens every time with a vaccine trial. They have many people they are testing on and some of those will get sick anyway in life. There is no proof that the vaccine has made them sick at all. But obviously they check literally everything when someone has got sick whilst going through a vaccine trial.

This is good. The testing is vigorous and shows they're making progress!

notevenat20 · 09/09/2020 09:20

It would be unblinded to the review board and the regulatory authorities, AZ and the investigators (and of course the subjects) remain blinded.

Yes but... If they only pause the trial if the person did not get the placebo then they have just unblinded it for one of the participants. That's why I was wondering what the protocol is.

Also these trials are meant to be double blind I believe so the investigators shouldn't know either.

Keepdistance · 09/09/2020 09:37

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.

raviolidreaming · 09/09/2020 09:38

The volunteer can be told if it is an important matter for their health and they need to know

Absolutely. I'm in the trial and at my last appointment was told that if the vaccine is rolled out for healthcare workers before its official end then we'll be unblinded to know if we've had it.

Also worth remembering that there is no placebo. The meningitis vaccine is being used as a control, so technically a reaction could be from either vaccine - or neither.

tootyfruitypickle · 09/09/2020 09:42

OP I get you . I think the vaccine thing is prob ok, they just have to check out if the illness is linked.
I’m awaiting cancer check tests. Got news end of the last week that the symptoms I have could be for a cancer I am already high risk for. It’s put into stark relief for me that it’s a very different ball game living through this if you’re vulnerable (and I don’t even know if I will be). So I get you . But honesty I think the vaccine will still come and you will be vaccinated early next year x

raviolidreaming · 09/09/2020 09:43

Keepdistance - where did you find this information please?

Keepdistance · 09/09/2020 09:46

This reply has been deleted

Message withdrawn at poster's request.

Keepdistance · 09/09/2020 09:49

This reply has been deleted

Message withdrawn at poster's request.

Cornettoninja · 09/09/2020 09:52

Drug trials are usually 3 - 5 years

@SebandAlice, true but there are factors that can reduce this time and still fulfil the same safety criteria. A lot of this time is spent obtaining funding, locating suitable candidates and peer reviews. All of these can be safely brought forward without affecting the safety of the trial compared to other drug trials.