# Covid-19 vaccines: Many ADRs are already expected



## Becky1951 (Nov 30, 2020)

Re: Covid-19 vaccines: Many ADRs are already expected

Dear Editor

The Ted-tenders electronic daily: Supplement to the Official Journal of the EU, details a contract negotiated by the Medicines and Healthcare Products Agency (MHRA), dated 14.9.20 (1).

It states: “The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed”.

It further explains: “For reasons of extreme urgency under Regulation 32(2)(c) related to the release of a Covid-19 vaccine MHRA have accelerated the sourcing and implementation of a vaccine specific AI tool…… it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively. This will hinder its ability to rapidly identify any potential safety issues with the Covid-19 vaccine and represents a direct threat to patient life and public health”.

Why do they expect that a high volume of ADRs will be generated?

And would it not be more sensible to determine the safety profile of a Covid-19 vaccine while the stable door is shut, rather than monitor the galloping horse once it has bolted?

https://www.bmj.com/content/371/bmj.m4258/rr


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## MarciKS (Dec 1, 2020)

Then we know it could potentially be dangerous because there's not been enough testing.


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## Becky1951 (Dec 1, 2020)

MarciKS said:


> Then we know it could potentially be dangerous because there's not been enough testing.


Exactly.


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## win231 (Dec 1, 2020)

Not when this kind of money is involved.  The level of fear they're creating beforehand is a type of veiled advertising.


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## MarciKS (Dec 1, 2020)

I found a label for one but can't make heads or tails of the ingredients. Also there's a bunch of crazy links about crazy crap in the vaccines like weed killer and fetus parts.


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## Don M. (Dec 1, 2020)

All these drug companies are claiming that there are "minimal side effects", but, given the way this vaccine has been rushed, they Really Don't Know.  It could be months, or years, before we know for certain that there aren't additional risks involved.  Watching some of these drug commercials on TV is strong evidence that many drugs might cure "problem A", only to give the patient "problem B".  

There is likely going to be no "magic" cure, long term, for this virus, without some people having other issues arise, but that is almost to be expected.  This is going to be a tough individual decision.


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## Treacle (Dec 2, 2020)

https://www.bbc.co.uk/news/uk-55166292

Listened to the radio re: the Pfizer vaccine.  It would seem that 30,000 people were tested. 15,000 had the vaccine, the other 15,000 had a placebo (meningitis vaccine) in order to make sure no one knew what they were given. All vaccines, it was stated, produce sore arms and a a possible slight fever for a short time. What concerned me was the 'expert' said that all were asked to go about their usual activities, but during the time of the study there was no 'normal' or 'usual' activities , people had to wear masks/facial coverings and social distancing. My point is that how can they tell the vaccine worked if people had masks/face coverings and social distancing which was deemed necessary to avoid the transference of the virus. Have I lost the plot here?????


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## grahamg (Dec 2, 2020)

Treacle said:


> https://www.bbc.co.uk/news/uk-55166292
> 
> Listened to the radio re: the Pfizer vaccine.  It would seem that 30,000 people were tested. 15,000 had the vaccine, the other 15,000 had a placebo (meningitis vaccine) in order to make sure no one knew what they were given. All vaccines, it was stated, produce sore arms and a a possible slight fever for a short time. What concerned me was the 'expert' said that all were asked to go about their usual activities, but during the time of the study there was no 'normal' or 'usual' activities , people had to wear masks/facial coverings and social distancing. My point is that how can they tell the vaccine worked if people had masks/face coverings and social distancing which was deemed necessary to avoid the transference of the virus. Have I lost the plot here?????


Do they rely upon the vaccine producing the desired immune response to assess whether it worked, more than whether someone went on to be protected?


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## Becky1951 (Dec 2, 2020)

I would think they had to have tested each person for antibodies at the end of the trial period.


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## Sunny (Dec 2, 2020)

MarciKS said:


> I found a label for one but can't make heads or tails of the ingredients. Also there's a bunch of crazy links about crazy crap in the vaccines like weed killer and fetus parts.



Ah yes, the crazies are always out there, ready to inflict their insanity on one and all. You have to wonder, is it a bunch of idiotic high school kids with nothing better to do, especially now?  Or is there a mentally ill insurgency that haunts the internet?


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## win231 (Dec 2, 2020)

Don M. said:


> All these drug companies are claiming that there are "minimal side effects", but, given the way this vaccine has been rushed, they Really Don't Know.  It could be months, or years, before we know for certain that there aren't additional risks involved.  Watching some of these drug commercials on TV is strong evidence that many drugs might cure "problem A", only to give the patient "problem B".
> 
> There is likely going to be no "magic" cure, long term, for this virus, without some people having other issues arise, but that is almost to be expected.  This is going to be a tough individual decision.
> 
> ...


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## win231 (Dec 2, 2020)

If someone was vaccinated, or had Covid & recovered, wouldn't they have a positive antibody test?


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## grahamg (Dec 2, 2020)

win231 said:


> If someone was vaccinated, or had Covid & recovered, wouldn't they have a positive antibody test?


I think there remains some doubt on the question you've raised, but there are reports some do retain antibodies and added to that is the Washington Post article concerning an apparent level of immunity to Covid 19 of about 40% amongst some populations where the population hadn't been exposed to this virus before, (Mumbai in India being one such place I think?).


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## asp3 (Dec 3, 2020)

I was thinking about this last night and wondered if the high level of ADRs is due to the sheer volume of people taking the vaccine.  I doubt we've ever ramped up vaccine distribution as quickly as we are for Covid.  It could be the sheer number of people getting the vaccine will cover more people who might have a situation that hasn't been recognized yet as a risk for adverse reactions and we'll just hit more people in that group than we normally would.


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## Becky1951 (Dec 3, 2020)

The ADR's are expected to be high due to not enough time has elapsed in the study to fully know the future reactions.

Which is exactly why I won't be getting the vaccine until a few months have passed and its proven safe.


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## Treacle (Dec 3, 2020)

grahamg said:


> Do they rely upon the vaccine producing the desired immune response to assess whether it worked, more than whether someone went on to be protected?


Not sure @grahamg, could be. It just seems so confusing. Heard today that the vaccine may protect the individual from getting the virus but there is not enough research/data to conclude that the individual can/cannot transmit the virus. It will take time before that can be established. The Pfizer vaccine is here but it cannot be rolled out to those  in the high risk groups eg those in care homes until it can be securely placed at the temperature of -94f. 

https://www.bbc.co.uk/news/uk-55181665


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## asp3 (Dec 3, 2020)

grahamg said:


> Do they rely upon the vaccine producing the desired immune response to assess whether it worked, more than whether someone went on to be protected?



The reports I heard about their trials said that the control group that received the fake vaccine had a much higher number of Covid cases (I seem to recall 115) and I seem to recall 10 or 12 of those cases were severe (requiring hospitalization ???).  There 8 Covid cases in the group that got the vaccine and none of them had severe cases.

So they did look at how many cases those with and those without the vaccine got so to me that means they looked at the number that were protected and how well protected they were.

There should be some reports out there with the trial details.  I'm just going by my faulty memory.


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## grahamg (Dec 3, 2020)

asp3 said:


> The reports I heard about their trials said that the control group that received the fake vaccine had a much higher number of Covid cases (I seem to recall 115) and I seem to recall 10 or 12 of those cases were severe (requiring hospitalization ???).  There 8 Covid cases in the group that got the vaccine and none of them had severe cases.
> So they did look at how many cases those with and those without the vaccine got so to me that means they looked at the number that were protected and how well protected they were.
> There should be some reports out there with the trial details.  I'm just going by my faulty memory.


I accept what your memory has recalled as accurate, with the only reservation being the relatively small numbers of positive cases of Covid infections reported in either group after they were jabbed, so the level of protection afforded may be as good as reported but there can be statistical error in those trials where numbers or sample size is smallish..


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## asp3 (Dec 4, 2020)

grahamg said:


> I accept what your memory has recalled as accurate, with the only reservation being the relatively small numbers of positive cases of Covid infections reported in either group after they were jabbed, so the level of protection afforded may be as good as reported but there can be statistical error in those trials where numbers or sample size is smallish..



I think that's a great way of looking at it.


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## Don M. (Dec 4, 2020)

When these vaccines are approved, and released for use, the first couple of months will tell us quite a bit.  Medical staff and nursing home residents have the earliest priorities, in most States.  Their reactions to these vaccines will be more relevant, IMO, than the "trials"....we will be seeing the results on large numbers of people who Must continue to work, and the effects on large numbers of people with "preexisting" conditions.  If these two groups show minimal problems, that will, hopefully, encourage the general populations to start getting the vaccines.  

My wife and I are hoping that the results are positive by early Spring, so we can get the shots, and begin to resume our normal lives, without having to worry about someone "sneezing" near us.


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