Meet the Other Phone. Flexible and made to last.

Meet the Other Phone.
Flexible and made to last.

Buy now

Please or to access all these features

Covid

Mumsnet doesn't verify the qualifications of users. If you have medical concerns, please consult a healthcare professional.

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:
Hereinthesticks · 09/09/2020 11:48

If this one fails, there are plenty of others coming up behind it.
Just got to hope the government have reserved/bought stocks of vaccines being developed abroad also, which I gather it has for a couple of other vaccines. Hope this true and that these are not from the EU because the EU is not going to give us anything right now, Boris has properly destroyed that relationship.

TheKeatingFive · 09/09/2020 11:51

Hope this true and that these are not from the EU because the EU is not going to give us anything right now

I don’t think that’s true at all. It’s hardly in their interests to have a heavily infected UK right beside them (and sharing a border).

Hereinthesticks · 09/09/2020 11:52

OK, just unfortunate timing isn't it - Brexit negotiations going on while vaccines are being developed in a pandemic. The EU are working as a unit in this and we are now on the outside and actively antagonising them.

TheLastStarfighter · 09/09/2020 12:05

I get it OP. I hadn't realised how much I had been looking at the Oxford trial as light at the end of the tunnel, until I read that it was paused last night and it really hit me.

If nothing else, at least I am now more aware that I was pinning my hopes on it.

Hopefully all will turn out fine, but if not then eventually there will be either another vaccine or a very effective treatment.

MadameBlobby · 09/09/2020 12:14

@notevenat20

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.

Thank you
Worriedmum999 · 09/09/2020 12:19

I thought it was a blind trial which wasn’t to be ‘unblinded’ until end of September which is why they don’t know if it’s successful until the very end? Or are they allowed to look what vaccine that person has had if they get sick? I don’t know.

OP posts:
Hereinthesticks · 09/09/2020 12:25

Yes, trials can unblind individual participants, for their safety if it is required due to their health. The rest of the trial can carry on (subject to causal relationship assessment) and remain blinded.

RedToothBrush · 09/09/2020 12:37

@TheLastStarfighter

I get it OP. I hadn't realised how much I had been looking at the Oxford trial as light at the end of the tunnel, until I read that it was paused last night and it really hit me.

If nothing else, at least I am now more aware that I was pinning my hopes on it.

Hopefully all will turn out fine, but if not then eventually there will be either another vaccine or a very effective treatment.

Psychologically we all cope with this situation by creating mental points of reference in terms of progress.

A lot of the problem we have now is really about how the government weren't honest from the outset about how long this would last and many people have felt that when the original lockdown ended that was it.

It never was.

I think its created false beliefs and expectations tbh.

For those who see the importance of a vaccine, its quite natural to look at this trial as being the end. But it needs some context too.

Even if a vaccine is approved fairly quickly (by that i mean by the end of the year which is potentially optimistic), we still have to role it out and the logistics of vaccinating our entire population are horrendous. We cant manage the capacity of our track and trace system at present. We will need a priority system, so someone has to work that out, and rank everyone by need. Then you need to set up locations for vaccinations, taking into account not everyone has access to a car or may not be able to afford public transport to a centralised location for their whole family, a booking /rebooking system that a) works b) doesnt crash on launch, youve got to staff it with trained people, you need the relevant PPE and equipment to administer the vaccine etc etc.

Realistically? I think the best case scenario is probably role out is likely to start out next spring, and continue throughout the summer and into next autumn.

But it isnt all doom and gloom to say this. Just realistic, and thats not the whole picture anyway.

The most obvious point is that every case does mean that natural immunity in the population will increase over time even if we dont hit herd immunity levels. That will hopefully start to eventually slow transmission. Ideally we dont want everyone to get it and we want to limit the death rate, but in the interrim a slow ticking over of people catching the virus isnt a complete disaster. We want to avoid spikes and the vulnerable getting it, but arguably we do want to increase natural immunity regardless of the vaccines eventual completion date, precisely because we dont know when that will be.

In the meantime i think we are more likely to see developments in identifying people who are highest risk much better through other avenues of research. We could well see people with high risk conditions being screened for specific risk markers before a vaccine is ready with a certain degree of success. Maybe something like a blood test which highlights a raised level of something we can already test for fairly easily. Which could reduce the need for risk management for the population as a whole. I think other areas of research such as identifying who is most at risk and ways to treat the virus once your got it have been undervalued in terms of their importance tbh.

The vaccine being approached is neither the end point nor is it the be all or end all.

And theres multiple vaccine projects out there.

In this sense even restrictions being reinstated arent necessarily a step back but a step forward in managed progress - psychologically we have to see this in this way. Thus the framing needs to be about the new restrictions supporting the schools reopening in terms of progress and importance rather than being a black and white step backward.

Im personally far more concern about government mismanagement of track and trace than a potential set back to the vaccine for this reason too.

Mismanagement is not a natural part of progress towards a conclusion. Its just poor planning, logistics and well mismanagement.

PatienceVirtue · 09/09/2020 12:40

I'm on the trial and had my booster shot postponed this week and should be hearing imminently as to when it will be rescheduled. They were very reassuring on the phone and explained that with this many people on the trial (I think they said 15,000 on the phone but can't be sure), these things frequently happen and it's nothing to worry about.

To be fair, I wasn't particularly worried anyway. I don't know if I'm completely deluded or have too much faith in science, but I trust the vaccine and my biggest concern is that I might have been given the meningitis placebo instead of the real thing.

ButteryPuffin · 09/09/2020 12:45

I am still optimistic about a vaccine and the Oxford vaccine in particular. This is very much the norm and we are still progressing faster than we could ever have hoped towards a vaccine being available. Don't lose heart. It's reassuring to know all the proper precautions are being taken even with the urgency.

MarcelineMissouri · 09/09/2020 13:22

@PatienceVirtue are you able to let us know when you hear about the rescheduling?

raviolidreaming · 09/09/2020 13:29

MadameBlobby did you deliberately ignore my reply and just thank the poster who gave you the answer you wanted?

TheLastStarfighter · 09/09/2020 13:50

Thanks @RedToothBrush for such a detailed response. I agree with everything you said, and had pretty much that as a timeline/plan in my head. But it still hit me, even though I wasn't expecting a vaccine to be imminent.

Particularly agree with what you said Psychologically we all cope with this situation by creating mental points of reference in terms of progress.

thekaratekid · 09/09/2020 13:53

One serious adverse event is really unlikely to de-rail a whole clinical trial. The person who experienced the adverse reaction could have an undiagnosed pre-existing condition which could have been exacerbated by the vaccine. This would just mean going forward that the vaccine is contraindicated in people with that particular medical history.

When a person on a trial presents with an adverse reaction the doctors have to assess whether in their opinion the reaction is reasonably possibly related to the vaccine or not. It is very hard to tell without further tests etc, so if there is a chance of a related reaction then they have to class it as a possible reaction. Usually then with further tests it is found to be something else.

Some reactions are also expected with certain drugs. For example, the pill can cause migraines. This would be an expected reaction and would be listed on the patient leaflet and also the drug manufacturer documents. When you are trialling a new drug or vaccine, you have to be very vigilant for any adverse reactions (as there are no expected reactions). This reaction could be found to be something like a 1/1000,000 risk and therefore the benefit is greater than the risk. All vaccines have potential side effects, trials are how we find out if the benefit outweighs the risk.

Hereinthesticks · 09/09/2020 13:58

Psychologically we all cope with this situation by creating mental points of reference in terms of progress I do worry about the over-70s, many of whom are staying at home and very isolated. My parents and neighbours are holding out for a vaccine before going to shops, travelling, seeing family.
I often think, all this hell would go away if there were a vaccine, even one that was only 50% effective would be an improvement. Apart from surrendering to the virus, getting it and hoping to survive and for some antibodies, what hope is there?

MarcelineMissouri · 09/09/2020 14:06

I found this article about the trials of the Oxford vaccine in India Which also contained this hopefully encouraging section:

"This incident in the UK will have no impact on the Indian vaccine trial being carried out by Serum Institute," said Adar Poonawalla, CEO of Serum Institute of India, that is conducting trials on the Oxford vaccine AZD1222 (aka ChAdOx1 nCoV-19) in India also known as COVISHIELD.
Adar Poonawalla added, "The reaction that has been reported is not directly linked to the vaccine. The person who has had the reaction had an existing neurological condition. During a vaccine trial such events are common place."
"Our production timelines are on schedule as planned," the Serum Institute CEO further said.

www.indiatoday.in/india/story/impact-on-india-covid-oxford-vaccine-trials-serum-institute-ceo-astrazeneca-adar-poonawalla-1720131-2020-09-09

Dinnafashyersel · 09/09/2020 14:15

The person who has had the reaction had an existing neurological condition

If this were the case then they would not / should not have been part of the trial. May be a "lost in translation" where there is a tendency to replace phrases such as "may have had" with "had".

rorosemary · 09/09/2020 16:13

@Qasd

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.

We already know it works due to the phase 1 and 2 trials. What we don't know is if it's safe and how well it works. Does it work for 50% of the people, or 70 or 90? No vaccine works for 100 % of the population. We also don't know how many people will experience side effects and how dangerous those are. Phase 3 trial will tell us this.
PatienceVirtue · 09/09/2020 16:17

@MarcelineMissouri of course I will, no problem.

I'm actually annoyed that this news got leaked - it would have never occurred to me to go to the press with it when I got phoned a few days ago. The fact that there was a similar incident in July that none of needed to know about shows that it's very standard, it's being thoroughly looked at and probably not an issue at all. Being publicised like this and the attendant doom and gloom is a problem though.

tobee · 09/09/2020 16:50

@Dinnafashyersel

The person who has had the reaction had an existing neurological condition

If this were the case then they would not / should not have been part of the trial. May be a "lost in translation" where there is a tendency to replace phrases such as "may have had" with "had".

I thought they were now recruiting older people and vulnerable people? After all they have to have a safe vaccine for them too?

CoffeeandCroissant · 09/09/2020 16:51

The CEO of Astra Zeneca has given some more details:

"The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning.

The woman’s diagnosis has not been confirmed yet, but she is improving and will likely be discharged from the hospital as early as today, Soriot said.

The board tasked with overseeing the data and safety components of the AstraZeneca clinical trials confirmed that the participant was injected with the company’s Covid-19 vaccine and not a placebo, Soriot said on the conference call, which was set up by the investment bank J.P. Morgan."
www.statnews.com/2020/09/09/astrazeneca-covid19-vaccine-trial-hold-patient-report/

tobee · 09/09/2020 16:52

Thanks for your replies about Sars vaccine @SaskiaRembrandt and @ODFOx

TheKeatingFive · 09/09/2020 16:53

I thought the whole point of phase three trials was to involve people with existing conditions to understand effects on them.

Interesting from the POV of being pregnant. Would anyone sign up to any vaccine trial if pregnant? Yet surely that’s an important cohort.

tobee · 09/09/2020 16:53

Good question

IrmaFayLear · 09/09/2020 16:55

What pissed me off was the almost gleeful way this was reported in the press and on the BBC. Instead of a tone of disappointment, there was a tone of schadenfreude, seemingly being pleased that the Oxford trial had possibly failed.

Swipe left for the next trending thread