With the Government giving a tenner for you to do it too! Anyway, Hands Face Space everyone.
SARS CoV-2 coronavirus / Covid-19 (No tin foil hat silliness please)
- Thread starter Don't Kill Bill
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Nothing suggesting it's related to the vaccine at the moment. Could be purely coincidental and the risk of adverse reaction would still be low if this is the only case.
That's the University of Oxford one, right?
Depends on how severe the reaction was and how many people have been testing it so far. Even if this is a 1:1000 reaction that's enough to torpedo it if the reaction is severe. Potentially billions of people could receive vaccination so that would equate to millions of severe reactions.
It would be 1 in 10000 now and if the reaction is that severe, an announcement will be made fairly soon that the trial is over. It was the same with a Europe vaccine candidate as well, not sure what one.
Interesting read here from the guys responsible for the Oxford vaccine, ChAdOx1 nCoV-19
https://theconversation.com/oxford-...o-get-our-coronavirus-vaccine-approved-144623
- Already vaccinated 17000 trial participants (half are in the control arm vs half in the intervention arm)
- vaccine being studied in US, UK, India, Brazil and South Africa with aim for results to be "generalisable" with volunteers over the age of 70 tested (but uncertain how many)
- 1 to 3 months later a second clinical endpoint of the trial will be studying efficacy, safety with a second "booster" vaccine dose
- travel and flight restrictions mentioned as a significant logistical barrier
- they are implying that while vaccines are studied for safety over more years, the trial for this vaccine is studying more volunteers
- "good chance" whether we'll know if its effective before end of 2020 which is before all the crazy stuff starts about regulation, manufacturing, storage, supply, post-marketing surveillance
Can see the use of a second booster vaccine dose as a clinical endpoint possibly delaying phase III result publications from a vaccine efficacy results point of view unless the single dose results are too good to ignore they'll want to gather all of the data before publishing.
https://theconversation.com/oxford-...o-get-our-coronavirus-vaccine-approved-144623
- Already vaccinated 17000 trial participants (half are in the control arm vs half in the intervention arm)
- vaccine being studied in US, UK, India, Brazil and South Africa with aim for results to be "generalisable" with volunteers over the age of 70 tested (but uncertain how many)
- 1 to 3 months later a second clinical endpoint of the trial will be studying efficacy, safety with a second "booster" vaccine dose
- travel and flight restrictions mentioned as a significant logistical barrier
- they are implying that while vaccines are studied for safety over more years, the trial for this vaccine is studying more volunteers
- "good chance" whether we'll know if its effective before end of 2020 which is before all the crazy stuff starts about regulation, manufacturing, storage, supply, post-marketing surveillance
Can see the use of a second booster vaccine dose as a clinical endpoint possibly delaying phase III result publications from a vaccine efficacy results point of view unless the single dose results are too good to ignore they'll want to gather all of the data before publishing.
Putting a phase III study on hold because of a single adverse event is very unusual. They must have unblinded the case. I’d love to know why. Must be a very concerning type of event. Maybe ADE?
They were criticised for adding restrictions on the eve of Eid so probably had to give some notice this time.I don't get this whole 'Oh, we'll do it from Monday approach'. What's that in aid of? If they're worried, and it's urgent, have it start sooner surely?
I was about to post that too. An encouraging read. Immediately ruined by the news about the trial being paused. Feck’s sake.
I doubt it, if it was ADE, it wouldn't just be restricted to one case. It's not unusual, it's normal protocol. It preserves the integrity of future findings.
They’ve said it’s routine in their statement:
The spokesperson described the pause as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.” The spokesperson also said that the company is “working to expedite the review of the single event to minimize any potential impact on the trial timeline.”
Most media reports are saying the person is expected to fully recover thankfully.
The participant is expected to make a full recovery according to sources. Probably just a more moderate reaction to the vaccine than the usual.
Maybe that’s my own unfamiliarity with vaccine trials. Pausing a phase 3 trial of a medicine because of a single adverse event is definitely unusual. Is it more common for vaccines?
Here’s a more detailed story about it. This bit is interesting/worrying.
Could be anything, ADE would be almost worst case scenario. Thinking about even with root cause analysis type of stuff how they'd establish causality.
You could have a situation where's somebody became ill with some nasty neurological thing without any way of proving it was the vaccine that did it with only temporal association suggesting it is.
Hoping it gets back on track and turns out to be nothing, huge blow nonetheless or maybe its a good thing identifying a safety concern.
I guess medicines at least have more of an assurance that they are not going to cause an adverse reaction that if an adverse reaction is seen, it is more worrying than in a vaccine trial which has a lot of unknowns. Some different reactions are to be expected more with vaccines. After all, it's not a medicine designed to make you feel better but rather something to give your immune system practice.
Excuse my ignorance but what is ADE?
Where antibodies have the undesired effect of making it easier for viruses to enter cells
Thanks for explaining
In the article I linked above they talk about DSMB’s from other vaccine studies reviewing their safety database because of this adverse event. So it does seem likely to be some sort of vaccine red flag. If not ADE, maybe something like Guillain-Barreé?
EDIT: Basically what you suggested. A nasty neurological thing!
My understanding is that its basically vaccination worsening infection rather than conferring immunity to it. Has been demonstrated in animal models for SARS and MERS.
Dengue Fever is an example of ADE in action as a disease process where antibodies against one strain are protective but if they encounter a different strain they actually makes things worse in an almost Trojan Horse style. By virtue of these ineffective antibodies binding the virus without neutralising it and worsening disease process by actually helping the virus to infect cells, amplifying viral replication, pushing the immune system into overdrive resulting in severe disease.
On another note, this is why vaccine trials are a long and arduous process. In large scale trials, illness can happen by chance which would understandably cause the trial to be postponed to allow for safety reviews like this. It's positive that they are at least going about this properly and not pressing ahead after the fact. Gives me more confidence when a vaccine can eventually be approved.
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Panic over
Fingers crossed it is an unrelated issue.
Itis going to be permanent nervous time until we have a safe vaccine.
9 in stage 3 trials now if I remember correctly and kots more in stage 2. We really need one of the advanced stage vaccines to work rather than have to wait another 6 or 12 months.
Itis going to be permanent nervous time until we have a safe vaccine.
9 in stage 3 trials now if I remember correctly and kots more in stage 2. We really need one of the advanced stage vaccines to work rather than have to wait another 6 or 12 months.
I really hope so. Do we if there is a target end date for stage 3 trials?
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Interesting that the first wasn’t announced but this one has been though.
They are waiting to have enough data to determine efficacy which depends on people in the trial being exposed to the virus. They can't be too sure how long this can take.
The first one was possibly resolved quickly and didn't involve hospitalisation like this one.
Edit: the first was deemed unrelated to the vaccine. This is still unknown, hence why it has been announced
Makes sense.
And I wonder what a pause means? If everyone in the trial has had their jab already then not much, as long as each incident is investigated and found to be unrelated. If not then every pause pushes the end date out.
Glad they are handling the trial well, as you would of course expect.
Was my first thought/fear too. Let's hope not, because if it exhibits the potential for ADE, future waves of covid could be much more deadly.
Thankfully the investigation is only expected to last a few days. It is very likely to be unrelated but we'll see when the investigation is completed.
From my limited reading I think coronaviruses can potentially cause ADE but this study didn't find it a factor for SARS which gives me hope.
https://www.pnas.org/content/101/26/9804
He says nervously.
Someone suggested to me that this could have come about in line with the pledge to uphold safety procedures in all vaccine trials by major pharmaceutical companies in response to political calls to fast track approval.
The best piece I’ve read on it (if you really want to get into the weeds):
https://www.nature.com/articles/s41586-020-2538-8
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Says the trials are expected to resume in a few days
Govt: Young people, go back to work, save the economy, it is safe for schools to go back
~1 week later ~
Govt: Goddamn young people spreading the virus, how dare you.
~1 week later ~
Govt: Goddamn young people spreading the virus, how dare you.
As long as it is not ADE, it should be fine. 1 in 30K cases, even if it does adverse effects, it is still acceptable. If it actually turns out that the vaccine makes things worse, then that is a bit problem.
The good news is that the other vaccines are doing quite well. I have yet to hear anything bad about Moderna's vaccine (whom together with the Oxford's one seem to be the Western frontrunners).
The good news is that the other vaccines are doing quite well. I have yet to hear anything bad about Moderna's vaccine (whom together with the Oxford's one seem to be the Western frontrunners).
Correct, encouragingly, most vaccines that have so far made phase 2/3 trials are not reporting serious side effects from the actual vaccine.
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