Vaccine trials

[advent2016]

I've been offered to join a vaccine trial.

Has anyone else been offered, accepted and what do you think generally about it

[winkywanky]

I've offered my services on the UK.gov website.

I do have asthma (very mild) though, so suspect I may not be contacted.

If I were contacted, I would go for it.

[king tarzan]

I wouldn't do it.. my life ain't cheap as to I get used as a guinea pig..
No thanks

[pewpewpew]

Are there any perks for you to join the trial?

[winkywanky]

...I hear they're currently overrun with mango and desperately seeking more men...

[king tarzan]

...I hear they're currently overrun with mango and desperately seeking more men...

I only have a aged king cobra to offer now!!

[magpie252]

OP - If it's a Stage 3 Trial, I'd not worry, the drug/vaccine has gone through vigorous tests to ensure that it's safe for use in humans during Phase 2.
Your only 50/50 that you'd actually get the vaccine or a placebo.
The whole point of a Phase 3 Trial is to validate the results from earlier trials in a much larger test population.

WW - In Phase 3, the test need to cover both genders, age groups, ethnic backgrounds & pre existing medical conditions, as somebody with a mild condition, you'd actually be a good candidate

[Hobbit]

I only have a aged king cobra to offer now!!

Would you do it for 2 free mangoes?

[JamesKW]

I've offered my services on the UK.gov website.

I do have asthma (very mild) though, so suspect I may not be contacted.

If I were contacted, I would go for it.

You would be an ideal candidate,to see if it is effective they should be testing it on the aged and those with underlying health conditions,not much use testing it on the healthy.

[king tarzan]

All done and dusted... At least 3... Logistics process now and rock and roll Pedro👍👍👍👌👌👌👌

[winkywanky]

OP - If it's a Stage 3 Trial, I'd not worry, the drug/vaccine has gone through vigorous tests to ensure that it's safe for use in humans during Phase 2.
Your only 50/50 that you'd actually get the vaccine or a placebo.
The whole point of a Phase 3 Trial is to validate the results from earlier trials in a much larger test population.

WW - In Phase 3, the test need to cover both genders, age groups, ethnic backgrounds & pre existing medical conditions, as somebody with a mild condition, you'd actually be a good candidate

I was actually joking about men and mangoes (perhaps that could be a new TV channel, somewhat in the vein of Men & Motors?) but if it gave you the opportunity to enlighten us further about the progression of a new vaccine, so much the better 

As for me being a good candidate, I've been somewhat disappointed to find that in life generally, being a good candidate means diddly squat and there's normally hordes of noisier and much more demanding people who seem to take my place 

[winkywanky]

You would be an ideal candidate,to see if it is effective they should be testing it on the aged and those with underlying health conditions,not much use testing it on the healthy.

As a pre-existing condition you could only tick the asthma box on or off, with no indication as to severity. Mine is very mild and underlying rather than actual attacks. But I'll have been lumped in with every poor fucker whose everyday life is defined by shortness of breath.

[chrishornx]

I was actually joking about men and mangoes (perhaps that could be a new TV channel, somewhat in the vein of Men & Motors?) but if it gave you the opportunity to enlighten us further about the progression of a new vaccine, so much the better 

As for me being a good candidate, I've been somewhat disappointed to find that in life generally, being a good candidate means diddly squat and there's normally hordes of noisier and much more demanding people who seem to take my place 

fear not Winky many on here will vouch for you being an ideal candidate .......

[winkywanky]

...for euthanasia?

[Wadebridge]

You would be an ideal candidate,to see if it is effective they should be testing it on the aged and those with underlying health conditions,not much use testing it on the healthy.

Spot on fella.
The phase 2 trials sound like they were a big joke.
The results on efficacy and safety of the vaccine on healthy volunteers in the 20 to 30 age group is probably going to produce starkly different results from if it had been tested on the 60+ and 70+ age group, many of whom will be taking a cocktail of other tablets daily, for heart disease, anticoagulation etc.
So do the phase 3 trials involve testing on all groups in a population, in a country riddled with out of control coronavirus, like India and Brazil for example?

[chrishornx]

...for euthanasia?

heaven forbid no

[Doc Holliday]

Spot on fella.
The phase 2 trials sound like they were a big joke.
The results on efficacy and safety of the vaccine on healthy volunteers in the 20 to 30 age group is probably going to produce starkly different results from if it had been tested on the 60+ and 70+ age group, many of whom will be taking a cocktail of other tablets daily, for heart disease, anticoagulation etc.
So do the phase 3 trials involve testing on all groups in a population, in a country riddled with out of control coronavirus, like India and Brazil for example?

Did you actually think that through before you posted it?

[Wadebridge]

Did you actually think that through before you posted it?

It was stated 'tongue in cheek'.
I know of course that only volunteers from the young and healthy age bracket from the world's 'diverse' population are being deliberately exposed to situations at risk of contracting coronavirus.
The point being debated was how 'safe' and 'viable' the vaccines will be for the more vulnerable sectors amongst our population. 

[winkywanky]

From what I'm hearing, although it's only the young and relatively risk-free who've been purposely exposed to the virus after receiving the vaccine (I can't remember the name of that type of trial, Doc H will know), the earlier trials where a placebo was given to half the volunteers involved people of all ages being left to get on with their everyday lives to see whether they caught Covid 'accidentally'.

From those that did catch Covid, it was worked out what proportion of them had received the vaccine vs. the placebo. That's how the 90% success rate was worked out. And that's also why (certainly with one of the vaccines I think?) they're able to say that a good level of immunity is achieved with older people.

I think that's what happened?

[Doc Holliday]

It was stated 'tongue in cheek'.
I know of course that only volunteers from the young and healthy age bracket from the world's 'diverse' population are being deliberately exposed to situations at risk of contracting coronavirus.
The point being debated was how 'safe' and 'viable' the vaccines will be for the more vulnerable sectors amongst our population.

So if the vaccine(s) are approved by the regulator the plan is to start the rollout with healthcare workers and the most vulnerable eg over 85s care home residents etc.

Do you think they would do that if it had only been tested on young healthy individuals?

[Doc Holliday]

From what I'm hearing, although it's only the young and relatively risk-free who've been purposely exposed to the virus after receiving the vaccine (I can't remember the name of that type of trial, Doc H will know)

Our posts overlapped slightly. It's called a human challenge trial. Very difficult ethically but if done is reserved for what is considered low risk individuals.

[winkywanky]

Our posts overlapped slightly. It's called a human challenge trial. Very difficult ethically but if done is reserved for what is considered low risk individuals.

That was the one  .

And I remember when the first trials were being conducted, they were saying that an effective Lockdown would actually hinder the progress of the search for a vaccine because ideally you want people in the trial to be exposed to the virus in question.

Hence the use of Challenge Trials a bit later on, we were getting a bit desperate to move things along.

I think participants got a nice little wodge for their troubles too, around £2K or something, and being very well looked after with their own private rooms and Netflix etc? Wish I'd known where to apply  .

[Doc Holliday]

That was the one  .

And I remember when the first trials were being conducted, they were saying that an effective Lockdown would actually hinder the progress of the search for a vaccine because ideally you want people in the trial to be exposed to the virus in question.

Hence the use of Challenge Trials a bit later on, we were getting a bit desperate to move things along.

I think participants got a nice little wodge for their troubles too, around £2K or something, and being very well looked after with their own private rooms and Netflix etc? Wish I'd known where to apply  .

Indeed but they will be very fit 20 to 30 year olds so you've no chance    To my knowledge there haven't been any challenge trials as of yet with Covid? .... although I exclude countries like China and Russia in that cooment.

[winkywanky]

Indeed but they will be very fit 20 to 30 year olds so you've no chance    To my knowledge there haven't been any challenge trials as of yet with Covid? .... although I exclude countries like China and Russia in that cooment.

Yeah I know, tell me about it  .

I'm pretty sure there have been Challenge Trials in the UK? Quite recently. Certainly there was increased talk of it about 6wks ago, I assumed they'd started at least one?

[winkywanky]

...ah, starting in January: External Link/Members Only

[paulub45]

I've offered my services on the UK.gov website.

I do have asthma (very mild) though, so suspect I may not be contacted.

If I were contacted, I would go for it.

Well done to you Sir

[Pedalwall]

I signed up to be part of the Oxford vaccine trial earlier this year. They were looking for people to join a local trial and I couldn't really come up with a reason not to. There are no perks beyond you get a health check at the start, do a weekly swab test - all negative so far - so you have reassurance if you come into contact with large crowds out shopping etc, and are followed up on a regular basis. Think part of one trial there was some small payment made to some people but not for me on this one and not a motivating factor. They also make it clear that if you develop symptoms or have other health issues that there is no quick access to NHS you have to go through usual channels. Would encourage others who are thinking of being part of any ongoing trials - and despite the success so far trials are still necessary - to seriously consider it.

[Wadebridge]

I signed up to be part of the Oxford vaccine trial earlier this year. They were looking for people to join a local trial and I couldn't really come up with a reason not to. ...
Would encourage others who are thinking of being part of any ongoing trials - and despite the success so far trials are still necessary - to seriously consider it.

Well done. I assume the NHS were the ones to contact you at random, rather than you actively seeking to become part of a trial.
I assume you are still working age, as I've seen you've travelled to punts. Are you able to say if you're young, middle aged, or close to retirement? (Unless you're not comfortable with and don't wish to give anything away, which I'd understand of course).

So if the vaccine(s) are approved by the regulator the plan is to start the rollout with healthcare workers and the most vulnerable eg over 85s care home residents etc.
Do you think they would do that if it had only been tested on young healthy individuals?

Well one would assume not.
But upcoming and scheduled vaccine trials and their participant volunteers have featured quite a lot on the news over these last few weeks. And I have to say personally I have not seen anyone middle aged or pension aged in the spotlight. Maybe they're all 'camera shy'.
But seriously, as it must be the case that the more vulnerable age groups are participating and regularly, it would be good for this to be better visible in the public domain.
Because with all this talk of a promising vaccine, and achievable vaccination programme etc., it would be beneficial to the layman to understand how the 'vaccine task force' and associated authorities are actually reaching these conclusions of 90% efficacy and 95% efficacy with a degree of conviction and certainty.
Especially important now that the promise of a workable and deliverable vaccine is being hyped up as a reality. And particularly given what has gone on before with the Test and Trace fiasco, and the unquestionably vast void between hype and reality.

[Jimmyredcab]

Many people are saying they won’t take the vaccine, that’s fair enough but you may be banned from taking flights, Qantas have already stated that will be their policy.

[Doc Holliday]

But upcoming and scheduled vaccine trials and their participant volunteers have featured quite a lot on the news over these last few weeks. And I have to say personally I have not seen anyone middle aged or pension aged in the spotlight. Maybe they're all 'camera shy'.
But seriously, as it must be the case that the more vulnerable age groups are participating and regularly, it would be good for this to be better visible in the public domain.
Because with all this talk of a promising vaccine, and achievable vaccination programme etc., it would be beneficial to the layman to understand how the 'vaccine task force' and associated authorities are actually reaching these conclusions

The average layman isn't interested in the detail. If they are told that it works well for older people and is safe that is generally all the detail they require.

If however you want more detail it is publically available if you look for it. eg here for the Oxford vaccine External Link/Members Only

If you follow this link External Link/Members Only it will take you a very long PDF appendix, but if you scroll to pages 48 to 54 it will show the exclusion criteria for patients which is not aged based but only excludes those who have severe and especially poorly controlled underlying medical conditions which must be excluded from any trials until the trials are complete.

This links are all heavy going and way beyond my pay grade  but the information is there which those who can fully interpret it can do so and then relay to the layman audience the overlying conclusions.

Of course the sceptics and anti-vaxxers will still cry corruption but that is their choice.

Hope that is helpful?

[Chooser]

After recent results of vaccine trials, last week’s two results seemed to indicate either 93% effectiveness in one case and 97% in the second case. In the latest  “stunning” results from Oxford/Astra Zeneca, they were only indicating 73% effectiveness so for every 100 people vaccinated, 27 would still catch COVID-19!!

Is this another case of the UK celebrating mediocrity or could it be something to do with cost? The Oxford vaccine is apparently the cheapest by a country mile. 

[GingerNuts]

After recent results of vaccine trials, last week’s two results seemed to indicate either 93% effectiveness in one case and 97% in the second case. In the latest  “stunning” results from Oxford/Astra Zeneca, they were only indicating 73% effectiveness so for every 100 people vaccinated, 27 would still catch COVID-19!!

Is this another case of the UK celebrating mediocrity or could it be something to do with cost? The Oxford vaccine is apparently the cheapest by a country mile. 

From what I've read the effectiveness rates are:

   - Pfizer and BioNTech 95%
   - Moderna 94.5%
   - Oxford 62% with two full doses and 90% if given as a half dose followed by a full dose

The big advantage of the Oxford vaccine is that it can be stored at 2 to 8°C whereas the Moderna vaccine has to be stored at -20°C and the Pfizer and BioNTech vaccine at -70°C.

[RedKettle]

After recent results of vaccine trials, last week’s two results seemed to indicate either 93% effectiveness in one case and 97% in the second case. In the latest  “stunning” results from Oxford/Astra Zeneca, they were only indicating 73% effectiveness so for every 100 people vaccinated, 27 would still catch COVID-19!!

Is this another case of the UK celebrating mediocrity or could it be something to do with cost? The Oxford vaccine is apparently the cheapest by a country mile. 

70% would have been a stunning result without the others - that is more effective than many vaccines in use today.  In any case the indication is that by changing the pattern of doses they get to 90%.  It also seems 100% effective at stopping serious Covid cases.

Cost is important - this could be a major contribution to poorer countries which is handy if we decide to cut our aid budget.

[JamesKW]

After recent results of vaccine trials, last week’s two results seemed to indicate either 93% effectiveness in one case and 97% in the second case. In the latest  “stunning” results from Oxford/Astra Zeneca, they were only indicating 73% effectiveness so for every 100 people vaccinated, 27 would still catch COVID-19!!

Is this another case of the UK celebrating mediocrity or could it be something to do with cost? The Oxford vaccine is apparently the cheapest by a country mile. 

The vaccine cant actually stop you catching COVID 19,if you are standing next to someone with it you can get it.It just means your body is better able to fight it off if you get it and hopefully you dont get symptoms so less likley to pass it on.The flu vaccine for example is not always that effective for over 80s,so even if they have the flu vaccine they can still die from flu,maybe thats what they mean by the 27%.A good percentage of people dont die from or even get symptoms with COVID 19 without a vaccine(80%),in China they have gone back to pretty much normal life without a vaccine.

[Wadebridge]

Hope that is helpful?

DocH, thank you. Yes actually it was helpful. 

The average layman isn't interested in the detail. If they are told that it works well for older people and is safe that is generally all the detail they require.

Well if that doesn't make me an above average layman at least it makes me a more inquisitive one.
Very highbrow reading as you stated but tbh the link you posted does provide some 'insight' into the secret world of the vaccineologists (if that's a proper word). 

I did manage to imbibe this little snippet.
"By 28 days after the boost vaccination, similar antibody titres were seen across all two-dose groups, regardless of age or vaccine dose (eg, standard-dose groups: 18–55 years, median 20 713 AU/mL [IQR 13 898–33 550], n=39; 56–69 years, 16 170 AU/mL [10 233–40 353], n=26; and ≥70 years, 17 561 AU/mL [9705–37 796], n=47; p=0·68), and were higher than for those who did not receive a boost vaccination (appendix p 13). Similar results were seen with anti-RBD antibodies (figure 4; appendix p 12)"

So that at least tells me that the ChAdOx1 Oxford vaccine has been trialled across all age groups including those most vulnerable and weak (gt or eq 70 years).

As they obviously can't (deliberately) expose this group, or even 56-69yo and 18-55yo groups, to a real-life Sars-nCov-2, they look instead at how their immune system reacts when exposed to this doctored 'chimpanzee' coronavirus.
And they have sufficient expertise to predict and confidently know that the immune response will produce the same reaction, mitigating power (first wave antibodies) then killing power (T- cell badass assassins), to be 100% confident that the  Oxford vaccine would protect against an actual Sars-nCov-2 viral attack.

I'm also hearing on the news that the Oxford/AZ vaccine has been claimed to provide 70% efficacy.
So results not quite as good as the Pfizer vaccine (90%). But of course the Pfizer one has more difficult logistical challenges (storage) for a mass inoculation programme. 
And another thing Pfizer is no doubt keen to suppress is that it has had more lawsuits against it, historically; fairly or unfairly; for unwelcome side effects than any other vaccine producer. 

[Wadebridge]

70% would have been a stunning result without the others - that is more effective than many vaccines in use today.  In any case the indication is that by changing the pattern of doses they get to 90%.  It also seems 100% effective at stopping serious Covid cases.

That is indeed very encouraging news, if the statistics are reliable. (Lies, damned lies, and statistics; and all that).

From an earlier post of yours I believe you said you have had covid and recovered from it. That is indeed an enviable position to be in.

From what I've gathered; and I do myself know someone that has had covid; antibodies and Tcells that have successfully fought off a covid attack, offer long lasting protection.
Unlike flu, which typically mutates every season, nCov is not mutating to a degree likely to cause anywhere near the same level of concern.

[advent2016]

I work with a lot of scientists, consultant doctors, general doctors, specialist nurses, general nurses and combined they have a lot of knowledge. My knowledge mostly comes from wikipedia.

I've heard a lot of talk about "viral lode" and medical staff who have had Covid and recovered and have antibodies said if I understood correctly still shouldn't dive into a vat of covid-19 and should generally take precautions around highly infectious patients.

Q. Is that still the case when vaccinated?

To be honest when I'm working with female doctors and nurses installing IT equipment or some engineering stuff I'm still thinking  what's she like with her clothes off?  They ask me to fix phones, computers, cars, get free sky and I wonder why when they can open up a body with a scalpel do some intricate task, sew them up and they don't die they can't do this trivial stuff with computers.

[Doc Holliday]

DocH, thank you. Yes actually it was helpful. 

 

[Doc Holliday]

I've heard a lot of talk about "viral lode" and medical staff who have had Covid and recovered and have antibodies said if I understood correctly still shouldn't dive into a vat of covid-19 and should generally take precautions around highly infectious patients.

Q. Is that still the case when vaccinated?

Initially yes. Whilst it seems the vaccines are effective at preventing the virus going on to produce Covid, we do not yet know if, during that period in which the vaccine is working but the virus may still be present in say the respiratory tract, the virus can still be transmitted to others by the vaccinated person. This will be better judged over time and even if it is the case that vaccinated people can still be infectious, it will matter less and less as the vaccines are hopefully rolled out.

That said this pandemic has changed cross infection protocols forever (and rightly so) in terms of control of other existing respiratory viruses and of course any new ones that come along.

The Oxford vaccine story is also fascinating as it seems the higher 90% figure was accidentally achieved, due to human error in only giving a half dose to some patients during the first vaccine stage. Another one for the history books!

[Wadebridge]

in China they have gone back to pretty much normal life without a vaccine.

Yep. I think you're right there.
No urgent need for a mass inoculation programme currently, as China has virtually eliminated community transmission of covid, through a combination of 'draconian' measures and sensible behaviours.
It's interesting that infection cases, and deaths, are rising not just in UK, but across all of western Europe too. Even countries like Hungary and Poland are seeing concerning rising cases.
I guess it means that the whole of the free Western World is growing sick and tired of restrictions, 11 months into what has been a dreadful year.
If I were a betting man,  I'd wager that "tis the season to be Jolly" will win out over the '5 days of Christmas' over "Jolly Careful". We'll see.

[Jimmyredcab]

in China they have gone back to pretty much normal life without a vaccine.

So they tell us, I don’t believe the figures they have released, total deaths 4634 from a population of 1.4 billion, somethings not right. ???

[Pedalwall]

Well done. I assume the NHS were the ones to contact you at random, rather than you actively seeking to become part of a trial.
I assume you are still working age, as I've seen you've travelled to punts. Are you able to say if you're young, middle aged, or close to retirement? (Unless you're not comfortable with and don't wish to give anything away, which I'd understand of course).
Well one would assume not.

No, slightly more pro-active than that. There was an item on local news saying that both local hospitals and University were involved in the Oxford trial and looking for old farts and people from BAME background to be involved. I fit into the first of those although still working part-time so checked out the trial on the web, completed an initial online questionnaire and waited. Couple of weeks later got a phone call from one of the doctors involved in the research who completed a more thorough telephone triage and then invited me to an initial interview. At that the trial and involvement in it was further explained, health was checked and then signed consent and away we went. What you don't know - and won't until the end of the trial - is whether you receive the vaccine (followed by booster) or whether you just get the alternative and are part of the control trial.

I don't have any underlying health issues - at least none that I'm aware of - so the initial questionnaire was straightforward. Recognise that that doesn't apply to all.

[Chooser]

Ye gods!! Looks like based on this morning’s news that Oxford/AstraZeneca have shot themselves in both feet. Not only can’t they explain how some of the trial vaccines generated the results BUT they then added two or three sets of results together and came up with an “average” score. This in effect is not based on accurate scientific analysis.
In my earlier post I suggested “mediocrity “ was in the mix. Now it looks like at best poetic license or at worst good old fashioned deception is involved!?!?
Ultimately, who stands to profit? AstraZeneca. Who stands for lose? Us!! 

[winkywanky]

I presume you're referring to the 'accidental' discovery that halving the first dose (of two) led to a better immune response?

So long as they know exactly what they did and what the outcome was, and the size of the sample was significant, I don't see a problem with taking the Mean of the results. So long as they've been honest transparent in presenting the stats.

[Chooser]

Um! Not  sure about that WW. In today’s news articles, honesty and transparency are not key factors. Backtracking and fudge are more like it.Taking the mean of a series of results is not accurate as most importantly, it doesn’t leave them with one accurate dose to use!! 



Hidden Image/Members Only

[winkywanky]

Um! Not  sure about that WW. In today’s news articles, honesty and transparency are not key factors. Backtracking and fudge are more like it.Taking the mean of a series of results is not accurate as most importantly, it doesn’t leave them with one accurate dose to use!! 

It's accurate so long as you accurately report what really happened.

Don't forget, the biggest scientific achievements of mankind (and I'm not suggesting this is) were often as a result of accidents or mistakes.

I haven't actually read today's story, do you have a link?

Last I heard they were strongly prioritising investigating the 'anomaly' in question. In any case, AFAIK the lowest of the success rates was 60%, the annual flu jab is frequently only 50% and enough to stop rampaging epidemics. But obvs 90% is better than 60% so the sooner we find out what's really going oon with the way the vaccine works, the better.

[Chooser]

Sorry, can’t seem to copy the link but if you Google  “AstraZeneca manufacturing error”, the results will include an article from today’s Telegraph among others. 

[Hobbit]

I do worry about how they test vaccines because it doesn't sound like an effective way of testing. For example, what they do is give people the vaccine and send them off on their merry way to see if they get infected. But these people could be sitting at home all day and not going near anyone that has the virus. So how do they know for sure if the vaccine has worked? They don't, because it's a ridiculous way of testing something.

The best way to test it is to give them the vaccine and then after several weeks, give them the virus and see if it works. I know they were going to use that method on around 10,000 people and I understand there were ethical issues surrounding it but surely in a critical situation such as this, this would be the best way to test the vaccine?

[winkywanky]

I do worry about how they test vaccines because it doesn't sound like an effective way of testing. For example, what they do is give people the vaccine and send them off on their merry way to see if they get infected. But these people could be sitting at home all day and not going near anyone that has the virus. So how do they know for sure if the vaccine has worked? They don't, because it's a ridiculous way of testing something.

The best way to test it is to give them the vaccine and then after several weeks, give them the virus and see if it works. I know they were going to use that method on around 10,000 people and I understand there were ethical issues surrounding it but surely in a critical situation such as this, this would be the best way to test the vaccine?

Of those that become infected, you know how many/which ones received the vaccine rather than the placebo, therefore you can work out how effective the vaccine is. It works, you just have to have a large enough sample for it to be statistically significant. It's not ridiculous, it's internationally accepted good practice  . Of course what made things more difficult was the Lockdown which meant people were less likely to be exposed to the virus.

The second option is somewhat of a last resort, called a Challenge Trial and they're doing one of those in January.

[winkywanky]

Sorry, can’t seem to copy the link but if you Google  “AstraZeneca manufacturing error”, the results will include an article from today’s Telegraph among others.