Oxford Vaccine trial put on hold - participant suffers severe reaction

fmttmadmin

Administrator
Staff member
I hope it does not prove to be a major set-back. I was told last week that the vaccine would be ready by the end of September if governments were prepared to give the green light without the 30 000 volunteers. Maybe not very likely now but they have always said they could be ready in September.
 

Matt

Member
The headline is a bit disingenuous because there is no evidence to suggest this is a serious adverse reaction to the vaccine itself - just that someone within the trial has become poorly and it needs investigating. Very common in medical trials and is only making headlines because it's related to Covid19

There could be a problem, there could not be, but as usual the headlines are designed to entice clicks
 

asredastheycome

Well-known member
I hope it does not prove to be a major set-back. I was told last week that the vaccine would be ready by the end of September if governments were prepared to give the green light without the 30 000 volunteers. Maybe not very likely now but they have always said they could be ready in September.

Reading things like this will put people off volunteering even if it turns out not to be the cause of the vaccine. Could struggle to get 30000.
 

Matt

Member
Health Secretary Matt Hancock told Sky News' Kay Burley programme the pause is not necessarily cause for concern and that it has already overcome one such delay.

"It is obviously a challenge to this particular vaccine," he says.

"It's not actually the first time it has happened to the Oxford vaccine and it's a standard process in clinical trials."

Asked if it is a setback, Mr Hancock replied: "Not necessarily, it depends on what they find when they do the investigation. There was a pause earlier in the summer and that was resolved without a problem."

The nature of the adverse reaction and when it happened are not currently known. Clinical holds usually mean there is a pause in recruiting new participants and dosing current ones.

It is not uncommon for trials to be put on hold, but scientists are under pressure to develop a vaccine to help curb the pandemic.

Most serious adverse reactions that occur after vaccination are not related to the injection and are coincidental health problems, the World Health Organisation (WHO) has said.

When a vaccine is given to a large number of people, it is likely that a few people will experience a medical problem around the time of vaccination - but this does not prove any cause and effect.

Even so, researchers will need to investigate if there is any link.

Emphasis is mine
 

Cambsred

Active member
This is a normal procedure in a trial. The same process happened with the Hydroxychloriquine trials which were paused and have since restarted as the data was investigated and turned out to be false.

Trials often have safety concerns- and due to the rigorous nature of research they look for them and react accordingly for the safety of the trial participants.

When you are actively looking for adverse effects in a population of 2000 people you will find them across a long enough time period, just got to clarify if it is important, and secondly if it is a recurring theme.
 

hewielewie

Well-known member
This is a normal procedure in a trial. The same process happened with the Hydroxychloriquine trials which were paused and have since restarted as the data was investigated and turned out to be false.

Trials often have safety concerns- and due to the rigorous nature of research they look for them and react accordingly for the safety of the trial participants.

When you are actively looking for adverse effects in a population of 2000 people you will find them across a long enough time period, just got to clarify if it is important, and secondly if it is a recurring theme.
Isn't there a risk of a serious adverse reaction in any medication that is taken?
There is always the caveat that 1 in so many may get xyz
 

r00fie1

Well-known member
The raison detre` for trials is to measure effects on a controlled sample of participants - trials inevitably effect people in different ways.
Otherwise whats the point?:unsure:
 

Jonny_Rondos_Disco_pants

Well-known member
This is an adverse event. Wether it is an adverse reaction is unknown. That is why investigations take place. Something has happened to someone on the trial and those running the trial have to find out if it was due to the vaccine.
 

Attachments

  • DDD84521-F6E0-408C-8AF8-DF6A92F50738.png
    DDD84521-F6E0-408C-8AF8-DF6A92F50738.png
    79.4 KB · Views: 8

Cambsred

Active member
Isn't there a risk of a serious adverse reaction in any medication that is taken?
There is always the caveat that 1 in so many may get xyz

It is determining whether it is an adverse event, or serious adverse event. Side effects are expected for example a sore arm/ temperature/ cough etc.. However perhaps development of long term fatigue/ pneumonia/ a stroke/ c may not be expected and therefore are judged as serious adverse effects until investigated further.

All these symptoms could be expected in the general population, the key is deciding how related they are to the trial.
 

Liamo

Well-known member
There's no evidence yet that this is even due to the vaccine - that's what they're checking to find out.

As mentioned in the BBC article on this:

In large trials illnesses will happen by chance but must be independently reviewed to check this carefully.
 
Top
X