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V-day; am I the only one concerned?

8/12/2020

 
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.
Covid-19 vaccination day V-day
​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:
  • 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.
BMS
9/12/2020 06:30:22 am

Interesting read. However when you consider the implications of no vaccine for another year or two would you still prefer to wait? Another 60 thousand deaths, economic turmoil, significant mental health issues, burn out of NHS staff. It is a risk but surely better than the latter option.

David
9/12/2020 10:25:11 am

Thanks so much for the comment, you're absolutely right.

It really is a tricky dilemma. On the one hand we can possibly predict the outcome of no vaccine whilst having infection control practices to help control the spread and on the other hand we have vaccine we know very little about. For me the solution would be for the drug companies to publish their data. whilst it will be very early (only 2 months so far!) it would at least provide some information to help us decide what to do. At the moment it is hard to trust any company that doesn't make this type of information available.

I find it a very difficult situation and don't have any firm answers... just more worry!

Farah link
13/12/2020 09:18:58 pm

Dear Dr Garner,

Please know that if my tone here comes across as abrupt it is simply because I am not quite as eloquent as yourself in the written form; but also because I am rather disappointed to have read a lot of what you have written given that you are somebody I have looked up to since starting my micro/ID training. Much of what you state is rooted in conspiracy theory and you may have been able to save yourself and your readers much concern by looking at the evidence that already *IS* available. In actual fact, you are not asking "difficult questions" but rather questions that other people have already taken time to start answering. Instead, you are propagating fear and myth with this post. And I say that fully accepting of anyone saying they're nervous: of course everyone is, this is a scary time!

First and foremost it is a weak stance to take to try to convince people that vaccines are ok whilst simultaneously throwing shade at the MHRA. As the independent regulators of medicines throughout the UK, your comment is frankly unhelpful. The MHRA would frankly be utter fools to approve a vaccine because of any 'mates' in Big Pharma: it would jeopardise everything they have to do and risk vaccine uptake generally. Furthermore, if the MHRA were not taking efficacy and safety seriously, I would have expected them to favour the UK's efforts at producing a vaccine first, regardless of any data. This hasn't happened.

I completely agree with your wish to see the data and I'm not at all a fan of results by press release. But equally, I've not looked up the original trial results of the vast majority of medicines I've taken in my life- rather, I've trusted that the MHRA have, and have nothing to gain by causing me harm and frankly a lot to lose. It's also important to note that it's Phase 2/3 trial data that started from July. Most vaccine side effects will occur within 6 weeks of a vaccine. They've tested on over 40,000 participants. How much longer were you expecting them to test for before you were happy? Exactly what were you waiting for? "Longer term" is not the same as "large scale" effects, as I'm sure you understand. There will be rare effects that are picked up as the vaccines are rolled out. But that's a product of needles and haystacks, not a lack of data... (and I say this as someone who can't stand Big Pharma and doesn't like Pfizer at all, and would certainly like more efficacy info on the numbers in the older groups for example...).

As for points 1 and 2: these are arguments AGAINST COVID and not against a vaccine. I would be happy to point you in the direction of a number of sources on RNA vaccines should you wish. **Viruses** (and the majority of those you have named are actually DNA viruses...) can disrupt our DNA itself, interfere with programmed cell death and lead to cancers. RNA vaccines code for the Spike protein of the Covid virus; there is no RT protein to convert them back to DNA and they stay within the cell cytoplasm rather than cross the nucleus. They have been studied in humans for over 5 years, INCLUDING investigation as a treatment AGAINST cancers... As for autoimmune disease: dysregulated immune responses may lead to these but the evidence for this is predominantly in Infection, not with vaccines. Where GBS has been seen with, for example, the flu vaccine, the risk of vaccine-related cases has been similar to the risk of flu-related cases. There is no specific reason to think this would be different for the Covid vaccines.

Finally, ADE: this was a concern when the hunt for a Covid vaccine started. Having consented MANY patients for the Oxford Trial, I can tell you that it was a risk not taken lightly and repeated in 3 formats on at least 2 occasions to every participant. However, we've now a LOT of evidence for this not being the case in Covid:
- there is data from animal models
- we know we haven't seen it in human challenge models with HKU1 for example
- read the Phase 1/2 trial results from Oxford where they note simply an increase in the response levels in vaccinated patients with probable previous exposure
- there hasn't been an untoward signal in convalescent plasma studies...
- we have a few proved repeat infections and bar one, to my knowledge, each showed a milder second infection response
- whilst the data is conflicting, where there is evidence of cross-protection with other seasonal coronaviruses or MERS/SARS, again this has been protective against severe disease
- not all patients recruited to the trials were tested for their history of infection prior to vaccination, again without issue.

Anyway, I do hope this helps alleviate at least a few of your concerns. Feel free to look me up on Instagram where I spend a fair bit of my free time trying to tease apart fact from fiction and you may get some of your answers (eg, how have they manufactured a vaccine this quickly?; hint: funding, resource, a "plug and play" vaccine model, overlapping stages) as well as a few


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    Blog Author:

    David Garner
    Consultant Microbiologist
    Surrey, UK

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