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

[Worriedmum999]

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

This is not uncommon with clinical trials apparently, the Oxford trial has already been paused once before, this is the second time.

We don't even know yet that the illness (adverse effect) had anything to do with the vaccine.

This is what trials are for, so it shows that the system is working.

The UK government have hedged their bets by agreeing to buy 4 or 5 different vaccines, so only one needs to succeed.

The Oxford trial will be delayed, but hopefully only slightly. In any case it's the vaccinations in the US part of the trial that have been paused. As most if not all of the participants in the UK, Brazil and South African trials have already been vaccinated, they will still be collecting ongoing data from them.

You are panicking and catastrophising. I get it, this is so scary and we're all wrung out and stressed and bloody knackered. I can totally understand why you've posted but please take a big step back. It's not that bleak.

It's a precaution to pause things. It's likely a pause of a few days only while they check over this one individual (who it's possible has something else completely random wrong with them). Bear in mind the vaccine has already been assessed for safety (up to a point) and lots and lots of people have been vaccinated (thousands, in fact) and been absolutely ok. I'd be optimistic about saying they will confirm this is a random health issue and get on with the trial. There will be a vaccine and likely relatively soon. That's what all the experts are saying. And it's not even just about a vaccine, we have got so much better at helping people who are seriously affected. It's not like in March at all.

And no, the rise in cases doesn't necessarily mean a second wave, it's only the tiniest increase in deaths so far too (well below what many were expecting). We absolutely won't be living like this for years, I promise. Deep breaths. You are quite within your rights to feel scared but it's also worth sorting out what is anxiety and what is reality. for you and I'm sorry that you're vulnerable. That makes things so much harder.

Maybe read the whole report, instead of scaremongering. This is a perfectly routine pause that happens anytime someone on the trial gets ill. Could be anything and the scientists expect the trial to resume within days.

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.

For gods sake enough with the fear mongering. That's what happens with vaccine trials all the time. In fact they take years to get approved because you have to test the long term side effects as well so anything that you were hoping to come out soon will be a rushed job.

I don't know how you can live in this irrational fear all the time op, your mental health must be in shambles. BBC really got you good.

While my initial sight of the headline did give my heart a downward thump, it's actually very reassuring that they are, as they said, not rushing the vaccine through, doing the right thing. It's being paused and investigated as is absolutely correct.

The only immediate concern for me is people in the general population running with this issue to put them off having any vaccine at all. There are plenty enough people who might think like that for my liking.

It's not that bleak.

Nah ... It's all pretty bleak. I can't see the populations of those places put into more severe lockdown (particularly the young) reacting with much enthusiasm to the continued curtailment of their freedom. It does look like the beginning of a nightmare scenario.

I'm sure for lots of naice areas, enjoying low rates of infection and transmission and lots of lovely walks in the countryside and on the coast, the whole thing seems like someone else's problem. For people living in high density areas, maybe without private transport, going to NMW jobs on packed trains - now told they can't visit relatives, sit in restaurants, let their hair down ... it's all a bit shit, actually. Anxiety, loneliness, fury, fear - it's not a good mix.

I'm not looking forward to Winter.

I don't think this is bleak or scare mongering.
I think it's a step back to reality. Vaccine trials do fail. It's not an easy thing. Some of the vaccines wont make it.
I just think this counters the trump driven optimism that this will all be over by the election.
It will be over, but it will just take a little time and won't run to trump's election schedule.
Stock market seems to be falling again too.

We must not pin our hopes on a vaccine. Much more likely outcome is that as we learn more we can develop better treatments for the worst symptoms, thereby lessening the seriousness of the disease overall.
COVID 19 is basically SARS2, and we have been trying and failing to develop a useful vaccine for SARS for 18 years.

I thought they stopped developing the SARS vaccine because it burnt itself out?

@tobee

I thought they stopped developing the SARS vaccine because it burnt itself out?

That is what happened.

The illness could be a perfectly normal case of D&V picked up from anywhere. It happens really often in trials. There's no need for us to even know really.

New York Times:

“A person familiar with the situation, and who spoke on the condition of anonymity, said that the participant had been enrolled in a Phase 2/3 trial based in the United Kingdom. The individual also said that a volunteer in the U.K. trial had been found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca’s vaccine, remains unclear.”

OP don’t panic about this. It may be nothing to do with the vaccine, but we do need to check,

We can’t scrimp on safety checks. If it is a problem it’s good that we found it.

Equally there are many ponies in the vaccine race.

Try not to worry too much. More time money and effort is being put into finding a vaccine for this than ever before. Some of the best scientific minds being put to work. I have no doubt that records will be smashed. There are a number of promising developments.

however a vaccine available and produced for everyone globally is going to take time and the teams working on them have a fine line to tread between speed and safety.

Normally you wouldnt be seeing or paying much attention to vaccine development news but this is obviously a big story with more media attention on the ups and downs that are a completely normal part of the process.

It's totally normal that when you do a widespread testing of any medicin/vaccine that someone might get sick during the procedure. They then halt it to see if it's a coincidence or caused by the trial. Take a population of a few thousand people, don't test anything and still someone will get sick of something within a month or two. It's normal. So basically there is no drama, nothing to see here,

There has been a great deal of optimism about this vaccine, but it is only one of many in trials.

There were always lots of possible reasons why it might be unsuccessful, so you really can't count ones vaccines until they're hatched.

So try to un-pin those hopes - it's an uncertain process and it might all be fruitless. But there are other candidate vaccines, and the failure of one, even a high-profile one, will help the development effort as a whole. Because vaccines need to be safe - past ones, current ones and ones in development - and we learn from failure, problems and unexpected effects, and they all make for better vaccines in future

This is from the bbc website:

This is the second time the Oxford coronavirus vaccine trial has been put on hold, our correspondent notes. Such events are routine in major trials, and happen any time a volunteer is admitted to hospital when the cause of their illness is not immediately apparent.

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They are testing 30.000 people. One of them needed to go to the hospital for who-knows-what. The chances are very high that it was unrelated to the vaccine.

SARS still exists. Many Asian countries keep it under control with a solid track and trace system. These countries are now applying this to covid and are doing well with keeping it under control.

There are 30,000 volunteers in this phase of the trial so it’s to be expected that some of them will become ill with something not related to the virus. The participants’ illness may or may not be related to the vaccine.

@tobee

I thought they stopped developing the SARS vaccine because it burnt itself out?

There have been 3 human outbreaks of different strains, plus a few smaller ones after contamination from laboratory stocks of the virus. Work has never completely stopped. No vaccine has been successful because the immune response has been too short lived to make vaccination feasible. We may get lucky with COVID 19 but targeted treatments to prevent the lung and heart sequalae of infection in the worst cases is more likely to garner significant benefit imo.

Stuff like this happens in trials all the while, that’s why it usually takes a good while for new drugs to be tested, it’s only in the news because they are trying to rush it out

One of them needed to go to the hospital for who-knows-what. The chances are very high that it was unrelated to the vaccine

If the post above is correct and it was transverse myelitis (which is rare, about 300 diagnoses in Britain a year), the cause isn't fully understood but there is a possible association with the aftermath of infectious diseases, and maybe after other vaccinations.

www.myelitis.org.uk/uploads/1/5/8/2/15824690/10_facts_about_tm_-tm_awareness_day-_finalv2.pdf

@rorosemary

It's totally normal that when you do a widespread testing of any medicin/vaccine that someone might get sick during the procedure. They then halt it to see if it's a coincidence or caused by the trial. Take a population of a few thousand people, don't test anything and still someone will get sick of something within a month or two. It's normal. So basically there is no drama, nothing to see here,

Exactly. I think they’d been recruiting over 65 volunteers too so probably more likely to have things like this happen.

Plus, every medicine has a list of potential reactions - if you read the small print in every antibiotic / off the counter drug you’d never take anything.

Personally I think the opposite - I think that they are noting this now so it can be shown that (unlike perhaps some other trials that are allegedly going ahead in Russia and China) this one is taking all the necessary and usual safety checks to ensure everything is ok

Pressed post too soon!
With SARS the lung pathology was different than for CIVID, but when testing 3 different types of vaccine they found that where a significant antibody response was engendered, lung pathology described as idiopathic was seen ( ie even with different types of vaccine a similar lung problem developed in the subjects). That was in 2012 by the way: the research has never stopped.
Catching people with a strong immune response to the virus and muting the immune response ( eg with some steroids) is already showing positive results: we need to identify and target the particular process to switch off in patients. This will improve outcomes significantly.
I hope I'm wrong, but treatment is more likely to make a difference than a vaccine , based on what we know at this stage.