Before I start I’d like to state that I am pro-vaccination and have nothing personal against any drug companies or the Department of Health; but I am deeply concerned about how fast the new Covid-19 vaccination program is being rolled out. I realise there may be some people who will think I'm being irresponsible questioning the vaccination program for Covid-19 but I really am concerned about it. If you want the Covid-19 vaccine or have had it already then that’s okay, please don’t let me cause you to second guess yourselves. This is just my opinion and not that of any organisation I’m otherwise affiliated to, but I have been asked my own opinion many times so here it is.
There is still no published data on today’s new vaccine, no peer review or scrutiny of the pharmaceutical studies, and yet we are about to vaccinate 20 million people in the UK! Since when have we done medicine this way? We are supposed to be practicing evidence based medicine… WHERE IS THE EVIDENCE?!
The Medicines & Healthcare products Regulatory Agency (MHRA) say there is evidence of the safety and efficacy of the Covid-19 vaccines. Great! However my concern is that this is NOT as “independent” as widely proclaimed but rather MHRA are part of the Department of Health and the approval of any such medicines is entirely funded by the pharmaceutical industry! How “independent” can any organisation be when they are funded to provide an answer by the producer of the medicine; surely providing any unwelcome answers could possibly be “discouraged”?
So there is “evidence of safety” for this vaccine but where is this evidence? Certainly not in the Information for Healthcare Workers published on the DoH website. Not only that, but the DoH has changed the rules to which the MHRA can work including making it easier to approve a vaccine, simpler to give such approval and importantly removing the civil liability of the pharmaceutical companies. That’s pretty scary! If there is “safety and efficacy evidence” publish it. We are still reliant on just the press releases on the Pfizer website to make or provide “information for informed consent”. What will you be telling yourselves or your patients regarding the risk of reactions or long-term effects?
This vaccine trial started recruiting people at the end of July with a 1 month vaccination schedule. Data was going to be collected at 1 month, 2 months, 6 months, 1 year and 2 years… yep, this is a 2 year study and so far there can only possibly be 2 months of data (the earliest 6 month collection point is February 2021) yet we’re about to vaccinate 20 million people! Apparently these vaccines are safe and effective even though the study hasn’t even come close to finishing!
In my humble opinion, this is all too fast and goes against everything we are now taught about medicine. Look at the evidence and peer review, weigh up the potential for errors and bias, look at the long-term effects and then decide if it is the right thing to do. It appears to me that fear of Covid-19 is being used to “push” this vaccine out to the public as quickly as possible. It feels like we’re going back to the early 1900s when people just did what their Doctor told them to do, whatever was involved, and without questioning whether it was right or not. Crikey, my wife believes me when I say 2x jam doughnuts QDS is the treatment for the “common cold/flu”… I hate to break this to her but I have no evidence for this, just her unquestionably “feeling better” for the sugar hit! No evidence, but with over 20 years of experience during our marriage “I know” it helps her feel better so it must work!?
So what could go wrong? No, not with my doughnut prescribing! What could go wrong with the vaccine? What do I think the top 3 potential pitfalls could be with this new vaccine? I have no idea how likely these are; I have no evidence for whether they might happen or not. But that’s exactly my point… I have no evidence… period. This is a completely new type of vaccine; no other vaccine based on this technology has been used in humans before… so surely we should be being even more careful with its administration, not less careful.
1.Viral induced autoimmune diseases
There are lots of clinical conditions for which there is evidence that they might be caused by an autoimmune response triggered by a viral infection. They normally do this by eliciting an immune response (usually an antibody) that recognises both the virus AND normal human cells. The immune system then thinks that those normal human cells are part of the virus and so it mounts an immune response against those human cells and kills them too. If those cells are important (and they usually are!) then the immune response causes harm to the person.
Viral induced autoimmune diseases could include:
We know that SARS CoV2 has triggered a Kawasaki-like syndrome in some children, as well as a hyper-immune response in adults; the one that is the main reason for people dying from Covid-19. Who knows if the vaccine itself might cause an autoimmune response?
2.Viral causes of cancer
OK so I get it, even saying the “C” word appears alarmist, but there are numerous examples of viruses that cause human cells to change and become cancerous. Viruses can induce “a cancer” by having “their genetic material” incorporated into the human cell causing the human cell to change and become essentially immortal. The cell then reproduces out-of-control and cancer occurs. Cancers take a long time to form and become apparent, and so we would not see evidence of this quickly.
These oncogenic (cancer-inducing) viruses include:
Let me be clear, there is no evidence that any current vaccines cause cancer. But the important point here for me is that it is often “genetic material being incorporated into cells” that triggers the cancer, and the RNA vaccine we are using is essentially lots of viral genetic material. Who knows if this vaccine might trigger cancer?
3.Potential immune enhancement or disease predisposition
Unfortunately there have been a number of spectacular vaccine failures in the past, which have seriously damaged public trust in vaccination programs. These include two Dengue vaccines that predisposed to severe Dengue infection by enhancing the immune response to Dengue Virus rather than protecting against it, and a rotavirus vaccine that predisposed to a life-threatening bowel condition called intussusception. Again I do not wish to be alarmist; fortunately these types of problems are rare but…
The vaccine predisposition to these conditions was not apparent in the small clinical trials of these vaccines and only became apparent after they were used in more people. The same could or could not be true of the Covid-19 vaccines; we simply do not know as this vaccine study is too small and too early on. However, rather than slowly ramping up vaccination numbers and seeing side-effects increase with usage that were not apparent in the small numbers, we are about to mass vaccinate 20 million people. Even an effect as uncommon as 1 in 10,000, which may not be apparent in the original Covid-19 vaccine trial which only vaccinated 20,000 people, could affect 2,000 people when 20 million are vaccinated… and it would be too late! You can’t remove the vaccine after you’ve given it!
Vaccines are critically important!
Vaccines are a critically important tool in the armament against infectious diseases but a bad vaccine can set back public health drastically. Just look what the false claims of the “rogue scientist” Andrew Wakefield did back when he said the MMR vaccine caused autism… and this was untrue. What would be the damage if a Covid-19 vaccine actually caused a serious problem we don’t yet know about? I shudder to think! How will I convince people to have their flu vaccine then? Also, remember that vaccines are given to healthy people and so any harm a vaccine causes them is “additional harm” that wouldn’t have occurred if they hadn’t been vaccinated, and therefore the “acceptable risk” is usually very low.
We have already had a number of medical scandals in the UK. Perhaps the most infamous occurred when haemophilia patients were given HIV contaminated blood back in the 1970s and 1980s. Are we going to be in a position in 40-50 years’ time when we look back at what is happening now and ask “how did we let this happen?” I sincerely hope not, but I can guarantee you this, those making the decisions today will not be around to answer for what they did. Should we be asking the difficult questions? Is anyone brave enough to go against incredibly popular opinion and ask the difficult questions??!
I know this isn’t what people want to hear. I desperately want a vaccine too, but perhaps our desire is too strong and it is clouding our judgement, introducing bias into our normally calm scientific approach. Do we want this vaccine “so bad” that we’ll take all sorts of risks to get it? Personally I’m worried, very worried, it goes against everything I understand about evidence based medicine. I just hope I’m wrong and being unduly pessimistic… and if I am and it all goes well then I will be very happy indeed.
Reassuringly today, my Yogi tea bag tag says “may this day bring you peace, tranquillity and harmony”… I hope so too. And whilst writing this blog the Oxford Group HAVE published their data in the Lancet… it’s free to access and open to peer review. I’m going to read it now.
The Medicines & Healthcare products Regulatory Agency (MHRA) say there is evidence of the safety and efficacy of the Covid-19 vaccines. Great! However my concern is that this is NOT as “independent” as widely proclaimed but rather MHRA are part of the Department of Health and the approval of any such medicines is entirely funded by the pharmaceutical industry! How “independent” can any organisation be when they are funded to provide an answer by the producer of the medicine; surely providing any unwelcome answers could possibly be “discouraged”?
So there is “evidence of safety” for this vaccine but where is this evidence? Certainly not in the Information for Healthcare Workers published on the DoH website. Not only that, but the DoH has changed the rules to which the MHRA can work including making it easier to approve a vaccine, simpler to give such approval and importantly removing the civil liability of the pharmaceutical companies. That’s pretty scary! If there is “safety and efficacy evidence” publish it. We are still reliant on just the press releases on the Pfizer website to make or provide “information for informed consent”. What will you be telling yourselves or your patients regarding the risk of reactions or long-term effects?
This vaccine trial started recruiting people at the end of July with a 1 month vaccination schedule. Data was going to be collected at 1 month, 2 months, 6 months, 1 year and 2 years… yep, this is a 2 year study and so far there can only possibly be 2 months of data (the earliest 6 month collection point is February 2021) yet we’re about to vaccinate 20 million people! Apparently these vaccines are safe and effective even though the study hasn’t even come close to finishing!
In my humble opinion, this is all too fast and goes against everything we are now taught about medicine. Look at the evidence and peer review, weigh up the potential for errors and bias, look at the long-term effects and then decide if it is the right thing to do. It appears to me that fear of Covid-19 is being used to “push” this vaccine out to the public as quickly as possible. It feels like we’re going back to the early 1900s when people just did what their Doctor told them to do, whatever was involved, and without questioning whether it was right or not. Crikey, my wife believes me when I say 2x jam doughnuts QDS is the treatment for the “common cold/flu”… I hate to break this to her but I have no evidence for this, just her unquestionably “feeling better” for the sugar hit! No evidence, but with over 20 years of experience during our marriage “I know” it helps her feel better so it must work!?
So what could go wrong? No, not with my doughnut prescribing! What could go wrong with the vaccine? What do I think the top 3 potential pitfalls could be with this new vaccine? I have no idea how likely these are; I have no evidence for whether they might happen or not. But that’s exactly my point… I have no evidence… period. This is a completely new type of vaccine; no other vaccine based on this technology has been used in humans before… so surely we should be being even more careful with its administration, not less careful.
1.Viral induced autoimmune diseases
There are lots of clinical conditions for which there is evidence that they might be caused by an autoimmune response triggered by a viral infection. They normally do this by eliciting an immune response (usually an antibody) that recognises both the virus AND normal human cells. The immune system then thinks that those normal human cells are part of the virus and so it mounts an immune response against those human cells and kills them too. If those cells are important (and they usually are!) then the immune response causes harm to the person.
Viral induced autoimmune diseases could include:
- Type 1 diabetes mellitus
- Autoimmune encephalitis
- Autoimmune hepatitis
- Kawasaki’s disease
- Guillain-Barre Syndrome
- Thyrotoxicosis
- Multiple Sclerosis
We know that SARS CoV2 has triggered a Kawasaki-like syndrome in some children, as well as a hyper-immune response in adults; the one that is the main reason for people dying from Covid-19. Who knows if the vaccine itself might cause an autoimmune response?
2.Viral causes of cancer
OK so I get it, even saying the “C” word appears alarmist, but there are numerous examples of viruses that cause human cells to change and become cancerous. Viruses can induce “a cancer” by having “their genetic material” incorporated into the human cell causing the human cell to change and become essentially immortal. The cell then reproduces out-of-control and cancer occurs. Cancers take a long time to form and become apparent, and so we would not see evidence of this quickly.
These oncogenic (cancer-inducing) viruses include:
- Hepatitis B Virus
- Hepatitis C Virus
- Human Papillomaviruses
- Epstein Barr Virus
- Human Herpes Virus 8 (Kaposi Sarcoma Virus)
- Human T-lymphotrophic Virus (HTLV)
Let me be clear, there is no evidence that any current vaccines cause cancer. But the important point here for me is that it is often “genetic material being incorporated into cells” that triggers the cancer, and the RNA vaccine we are using is essentially lots of viral genetic material. Who knows if this vaccine might trigger cancer?
3.Potential immune enhancement or disease predisposition
Unfortunately there have been a number of spectacular vaccine failures in the past, which have seriously damaged public trust in vaccination programs. These include two Dengue vaccines that predisposed to severe Dengue infection by enhancing the immune response to Dengue Virus rather than protecting against it, and a rotavirus vaccine that predisposed to a life-threatening bowel condition called intussusception. Again I do not wish to be alarmist; fortunately these types of problems are rare but…
The vaccine predisposition to these conditions was not apparent in the small clinical trials of these vaccines and only became apparent after they were used in more people. The same could or could not be true of the Covid-19 vaccines; we simply do not know as this vaccine study is too small and too early on. However, rather than slowly ramping up vaccination numbers and seeing side-effects increase with usage that were not apparent in the small numbers, we are about to mass vaccinate 20 million people. Even an effect as uncommon as 1 in 10,000, which may not be apparent in the original Covid-19 vaccine trial which only vaccinated 20,000 people, could affect 2,000 people when 20 million are vaccinated… and it would be too late! You can’t remove the vaccine after you’ve given it!
Vaccines are critically important!
Vaccines are a critically important tool in the armament against infectious diseases but a bad vaccine can set back public health drastically. Just look what the false claims of the “rogue scientist” Andrew Wakefield did back when he said the MMR vaccine caused autism… and this was untrue. What would be the damage if a Covid-19 vaccine actually caused a serious problem we don’t yet know about? I shudder to think! How will I convince people to have their flu vaccine then? Also, remember that vaccines are given to healthy people and so any harm a vaccine causes them is “additional harm” that wouldn’t have occurred if they hadn’t been vaccinated, and therefore the “acceptable risk” is usually very low.
We have already had a number of medical scandals in the UK. Perhaps the most infamous occurred when haemophilia patients were given HIV contaminated blood back in the 1970s and 1980s. Are we going to be in a position in 40-50 years’ time when we look back at what is happening now and ask “how did we let this happen?” I sincerely hope not, but I can guarantee you this, those making the decisions today will not be around to answer for what they did. Should we be asking the difficult questions? Is anyone brave enough to go against incredibly popular opinion and ask the difficult questions??!
I know this isn’t what people want to hear. I desperately want a vaccine too, but perhaps our desire is too strong and it is clouding our judgement, introducing bias into our normally calm scientific approach. Do we want this vaccine “so bad” that we’ll take all sorts of risks to get it? Personally I’m worried, very worried, it goes against everything I understand about evidence based medicine. I just hope I’m wrong and being unduly pessimistic… and if I am and it all goes well then I will be very happy indeed.
Reassuringly today, my Yogi tea bag tag says “may this day bring you peace, tranquillity and harmony”… I hope so too. And whilst writing this blog the Oxford Group HAVE published their data in the Lancet… it’s free to access and open to peer review. I’m going to read it now.
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