Covid 19 Vaccine - will you have it ?
Discussion
Prof Prolapse said:
monkfish1 said:
You sound like someone with knowledge of these things.
How is the lack of any long term testing being handled, given the the urgency and timescales do not permit it?
How does one conclude the probability of side effects when the sample size is so small?
These are serious questions. So far all ive established is that it will be safe, because, well just because! Whilst tendering for an AI system to keep track of the harms caused. Which are expected to be large in number. According to the tender documents.
Where will i find these published numbers you refer to?.
I'm a project manager, so not an expert in every field but happy to try and answer in general terms.How is the lack of any long term testing being handled, given the the urgency and timescales do not permit it?
How does one conclude the probability of side effects when the sample size is so small?
These are serious questions. So far all ive established is that it will be safe, because, well just because! Whilst tendering for an AI system to keep track of the harms caused. Which are expected to be large in number. According to the tender documents.
Where will i find these published numbers you refer to?.
The extent of safety testing is driven by the existing knowledge of the drug from preclinical testing, it's perceived risk, and safety signals during the trial. Following it's licence, it's then monitored in an ongoing fashion by independent committees, the pharma company and regulators. Your drug gets a licence before long term follow up. The MHRA's "yellow card scheme" is an example of this. Regulators can then instruct pharma companies to carry out additional research as required, or revoke a drug's licence if there's an adverse safety signal.
I work in Oncology, we work on stuff many times more toxic than anything here, our trials are typically concluded in a few years. Safety monitoring continues throughout its lifecycle however.
The sample size cannot be be "too small" by agreed methods. We cannot complete a trial until we accrue enough data to satisfy the statistical requirement to demonstrate safety thresholds are met. Bear in mind the necessary sample size is dictated by the size of the signal you are looking for, and every medicine has a risk. It also is independently agreed by regulators, and they ensure it is satisfied in the final data before issuing a licence. Safety monitoring does not stop at that stage.
Publication policies vary but press releases, and presentations at medical conferences, is the way you will find study data. We also often permit investigators to publish either by themselves or led by pharmaceutical companies. Full unrestricted view to the data by the general public I am not aware is generally permitted. The data is our commercial product, and often not presented in a form which could be easily interpreted.
A few, close to this, however, are saying that the vaccine wont be licensed, at least to start with. Hence no liability on manufacturer or government.
Which is one of my bigger concerns. Essentially, anyone that takes it is part of an extended experiment. With no recourse should it go pear shaped.
I can try.
When I did my immunology degree "alum" (Aluminimum) was the adjuvant we'd discuss. It's extremely well established and effective. How does it work? Well at the time we didn't know. It was speculated it would in fact cause small amounts of damage to the inside of blood vessels, provoking an immune response, where upon the immune system would stumble on the anti-gen, resulting in long term immunity.
An insult so small to the body it would save your life. Seemed reasonable to me.
Immunity is not guaranteed in any eventuality, and there are extremely small numbers reporting re-infection. I would think it would be offered for liability purposes if nothing else.
There's lots of instances in history where drug companies have been successfully made to pay out compensation because of failures in their processes.
But they won't be paying out for individuals who make claims which cannot be proven.
Immunity is usually long lasting, the human race would die out if it wasn't. You could already have immunity from existing strains of coronavirus (a fact ignored in government projections which worries me). There are always exceptions however, and if you're vulnerable it is a gamble many would think was not worth taking.
In an effective vaccine, after an antigen is present to the immune system it recognises the shape, and then the immune system itself destroys infected cells moving forwards. My understanding, is an anti-viral will instead act directly on the virus infected cells. The more you drill down into the mechanisms, I agree the more the lines get blurry however.
Your immune system evolved to last until you were approximately forty years old, after that it is in decline. It is incredibly complex, but without any intelligent design and has many limitations. Vaccines supplement your immune system to allow you fight infection. They allow it to identify their "enemy", so by not having your vaccine you're asking a ageing system to fight an unknown enemy for avoid a risk which is demonstrably minimal or not-existent. To each their own, but it's not a reasoned or informed stance.
I am a very fit man of thirty four, I get my flu vaccine. I also get my children immunised privately where possible. I literally put my whole family's welfare in the trust I have in the vaccination program and safety standards which exist. I do not believe such trust is misplaced.
TobyTR said:
I'd also like answers to these questions ^^^ along with:
- will the ingredients in the vaccine include Mercury/Thimerosal, Formaldehyde, Polysorbate, Aluminium and/or Monosodium Glutamate?
Depends on the vaccine. You've listed noxious chemicals there. Just bear in mind that the only difference between a poison and a medicine is the dose, and secondly that you must provoke an immune response for a vaccine to work.- will the ingredients in the vaccine include Mercury/Thimerosal, Formaldehyde, Polysorbate, Aluminium and/or Monosodium Glutamate?
When I did my immunology degree "alum" (Aluminimum) was the adjuvant we'd discuss. It's extremely well established and effective. How does it work? Well at the time we didn't know. It was speculated it would in fact cause small amounts of damage to the inside of blood vessels, provoking an immune response, where upon the immune system would stumble on the anti-gen, resulting in long term immunity.
An insult so small to the body it would save your life. Seemed reasonable to me.
TobyTR said:
- if somebody has already had Covid and fully recovered from it, will they be told to have a vaccine? If they are told to have a vaccine, why?
Guidelines will be provided. I don't have these.Immunity is not guaranteed in any eventuality, and there are extremely small numbers reporting re-infection. I would think it would be offered for liability purposes if nothing else.
TobyTR said:
- why are the vaccine companies now exempt/protected from liability from the government? For the covid vaccine for a virus that our own government lists (as of June 2020) as no longer an HCID (High Consequence Infectious Disease) on their website?
Compensation is not my field, but all manufacturers have a degree of legal responsibility to ensure their product meets safety guidelines. In research compensation is awarded in accordance with ABPI guidelines. I am unsure how it applies to licenced medicines.There's lots of instances in history where drug companies have been successfully made to pay out compensation because of failures in their processes.
But they won't be paying out for individuals who make claims which cannot be proven.
TobyTR said:
- If this vaccine is an antigen that binds to the S protein to trigger the immune system, which can remember & duplicate for the future, why state that those who have already had Covid can't guarantee to stay immune? It is imitating and triggering immune response the same... sounds like an anti-viral, not a vaccine...
There's multiple vaccines. The "Spike Protein" I think is unique to Coronaviruses so is frequently used as an antigen. I understand it was a fluke that Oxford was working on this when they produced their vaccine. Immunity is usually long lasting, the human race would die out if it wasn't. You could already have immunity from existing strains of coronavirus (a fact ignored in government projections which worries me). There are always exceptions however, and if you're vulnerable it is a gamble many would think was not worth taking.
In an effective vaccine, after an antigen is present to the immune system it recognises the shape, and then the immune system itself destroys infected cells moving forwards. My understanding, is an anti-viral will instead act directly on the virus infected cells. The more you drill down into the mechanisms, I agree the more the lines get blurry however.
TobyTR said:
I may consider having a vaccine once those questions have been sufficiently answered and once the vaccine efficacy rate is above 99.8%, seeing as my expected recovery rate from covid for my age and health demographic is currently 99.8%.... Until then I will happily rely on my immune system.
The efficacy rate of 99.8% is exceptionally high. I believe 50% is considered effective by the FDA to grant a licence but I understand there's lots of ways to measure efficacy. Your immune system evolved to last until you were approximately forty years old, after that it is in decline. It is incredibly complex, but without any intelligent design and has many limitations. Vaccines supplement your immune system to allow you fight infection. They allow it to identify their "enemy", so by not having your vaccine you're asking a ageing system to fight an unknown enemy for avoid a risk which is demonstrably minimal or not-existent. To each their own, but it's not a reasoned or informed stance.
I am a very fit man of thirty four, I get my flu vaccine. I also get my children immunised privately where possible. I literally put my whole family's welfare in the trust I have in the vaccination program and safety standards which exist. I do not believe such trust is misplaced.
I've had and recovered from COVID, and I'd most certainly take a vaccine.
I don't know anyone who's had any vaccine and suffered ill-effects beyond a sore arm and feeling a bit rubbish the next day, my family has always been vaccinated and if Andrew Wakefield hadn't done what he had I doubt any of us would be having these conversations.
The risk of taking it (and yes I know there's a risk with any drug) is for me far outweighed by the risk to my business (ongoing, significant and not getting any better), elderly relatives and society getting back to normal.
I don't know anyone who's had any vaccine and suffered ill-effects beyond a sore arm and feeling a bit rubbish the next day, my family has always been vaccinated and if Andrew Wakefield hadn't done what he had I doubt any of us would be having these conversations.
The risk of taking it (and yes I know there's a risk with any drug) is for me far outweighed by the risk to my business (ongoing, significant and not getting any better), elderly relatives and society getting back to normal.
monkfish1 said:
Thanks for the explanation.
A few, close to this, however, are saying that the vaccine wont be licensed, at least to start with. Hence no liability on manufacturer or government.
Which is one of my bigger concerns. Essentially, anyone that takes it is part of an extended experiment. With no recourse should it go pear shaped.
We've exhausted my limits of liabilities, statistical analysis and licences I'm afraid. A safety review will still always be required however, they just may not have satisfied the minute detail of the requirements.A few, close to this, however, are saying that the vaccine wont be licensed, at least to start with. Hence no liability on manufacturer or government.
Which is one of my bigger concerns. Essentially, anyone that takes it is part of an extended experiment. With no recourse should it go pear shaped.
Enitrely speculating but I would be amazed if there was not a legal requirement for a product to reflect the data presented in that provisional safety and efficacy review. As, and again this just an example, the delay could be something as daft as 93% confidence satisfied as opposed to 95% required confidence intervals, so not necessarily something to be concerned about. But very curious what the difference is.
A lot of people's reputations are on the line here. I really don't believe anything will go out that is even remotely dangerous.
UK authorises Pfizer/BioNTech COVID-19 vaccine
https://www.gov.uk/government/news/uk-authorises-p...
"A Department of Health and Social Care spokesperson said:
The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech’s COVID-19 vaccine for use. This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.
The Joint Committee on Vaccinations and Immunisations (JCVI) will shortly publish its final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.
The vaccine will be made available across the UK from next week. The NHS has decades of experience in delivering large-scale vaccination programmes and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination.
To aid the success of the vaccination programme it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS to do its work without being overwhelmed."
I'll avoid taking it for as long as possible.
"because COVID" has become a very convenient excuse for me not doing any of the things my wife usually forces me to do. Socialising, going to over priced restaurants, spending my next car fund on holidays I'd rather not go on etc. I'm dreading the old life returning.
"because COVID" has become a very convenient excuse for me not doing any of the things my wife usually forces me to do. Socialising, going to over priced restaurants, spending my next car fund on holidays I'd rather not go on etc. I'm dreading the old life returning.
nunpuncher said:
I'll avoid taking it for as long as possible.
"because COVID" has become a very convenient excuse for me not doing any of the things my wife usually forces me to do. Socialising, going to over priced restaurants, spending my next car fund on holidays I'd rather not go on etc. I'm dreading the old life returning.
So it might be fair to say your marital arrangement is the real issue! "because COVID" has become a very convenient excuse for me not doing any of the things my wife usually forces me to do. Socialising, going to over priced restaurants, spending my next car fund on holidays I'd rather not go on etc. I'm dreading the old life returning.
A bit of help needed here gents..
I had the 1st dose of the az vaccine a couple of days ago and now need to fly so obviously i need a PCR test but i’m worried that i’ll ping a positive due to the vaccine injection only 2 days ago.
Should i be worried? cant find anything definitive online
I had the 1st dose of the az vaccine a couple of days ago and now need to fly so obviously i need a PCR test but i’m worried that i’ll ping a positive due to the vaccine injection only 2 days ago.
Should i be worried? cant find anything definitive online
My wife was taken off birth control tablets due to having a risk of clotting as there is a history of it in her family. I know that you cannot choose which vaccine you can have, but does anyone know if there is any way to speak to the vaccine "givers" to see what options are available? My wife is in her 30s, so will likely be offered the astrazenica one.
TheAngryDog said:
My wife was taken off birth control tablets due to having a risk of clotting as there is a history of it in her family. I know that you cannot choose which vaccine you can have, but does anyone know if there is any way to speak to the vaccine "givers" to see what options are available? My wife is in her 30s, so will likely be offered the astrazenica one.
It may be prudent to talk to the GP. Although they may state it will make no difference (which vaccine is given) they could recognise the 'anxiety' (hope you don't mind me using that word), and have knowledge of where Phizer one is being given and arrange or advise how to get an appointment at the venue. My understanding is that GP surgeries use the AZ one because they're not well setup to offer the Pfizer one due to the temp requirements and the way it's packaged (lots of doses per pack to suit high volume vaccinations). The mass vaccination centres more likely to use the Pfizer one.
The Moose said:
I’m really rather surprised you’re not given the option of which jab to get in the UK.
Its a production line and you book your slot weeks ahead. You get whatever they're administering in your timeslot/vaccination centre.As we vaccinate younger people they will get a choice due to the AZ higher clot risk.
98elise said:
The Moose said:
I’m really rather surprised you’re not given the option of which jab to get in the UK.
Its a production line and you book your slot weeks ahead. You get whatever they're administering in your timeslot/vaccination centre.As we vaccinate younger people they will get a choice due to the AZ higher clot risk.
The Moose said:
That is astonishing.
Is it? They’re all approved and much the same in terms of effectiveness. Medical needs will take which one you get into account (for example, my dad had Pfizer due to allergies), but beyond that is there a “need” for a choice?I’m not qualified to understand what I’m choosing between...
Edited by DanL on Monday 19th April 13:18
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