Updated: Dec 25, 2020
Before you rush to get your Pfizer vaccine before Christmas, here's my list of what I feel are the main reasons to be very cautious.. Apart from the fact that it's not clear why the entire healthy population has to be vaccinated against something which is almost no risk to them, there are many other reasons to be hesitant.
The MHRA is expecting a high volume of adverse reactions. This article explains how they are searching for an AI tool to cope.
Dr Mike Yeadon’s letter to Matt Hancock on Twitter saying that the vaccine is experimental and there is no long term safety data. For anyone not familiar with Dr Yeadon, you can follow him on Twitter here. He actually knows Patrick Vallance as they worked together at Pfizer, and he is doing a fantastic job of giving him a very difficult time.
“Dear Mr Hancock,
I have a degree in Biochemistry & Toxicology & a research based PhD in pharmacology. I have spent 32 years working in pharmaceutical R&D, mostly in new medicines for disorders of lung & skin. I was a VP at Pfizer & CEO of a biotech I founded (Ziarco - acquired by Novartis). I’m knowledgeable about new medicine R&D.
I have read the consultation document. I’ve rarely been as shocked & upset.
All vaccines against the SARS-COV-2 virus are by definition novel. No candidate vaccine has been in development for more than a few months.
If any such vaccine is approved for use under any circumstances that are not EXPLICITLY experimental, I believe that recipients are being misled to a criminal extent.
This is because there are precisely zero human volunteers for whom there could possibly be more than a few months past-dose safety information.
My concern does not arise because I have negative views about vaccines (I don’t), Instead, it’s the very principle that politicians seem ready to waive that new medical interventions at this, incomplete state of development- should not be made available to subjects on anything other than an explicitly experimental basis. That’s my concern.
You have literally no data on this & neither does anyone else.
It isn’t that I’m saying that unacceptable adverse effects will emerge after longer intervals after dosing. No: it is that you have no idea what will happen yet, despite this, you’ll be creating the impression that you do.
Several of the vaccine candidates utilise novel technology which have not previously been used to create vaccines. There is therefore no long term safety data which can be pointed to in support of the notion that it’s reasonable to expedite development & to waive absent safety information on this occasion.
I am suspicious of the motives of those proposing expedited use in the wider human population. We now understand who is at particularly elevated risk of morbidity & mortality from acquiring this virus.
Volunteers from these groups only should be provided detailed information about risk / benefit, including the sole point I make here. Only if informed consent is given should any EXPERIMENTAL vaccine be used.
I don’t trust you. You’ve not been straightforward & have behaved appallingly throughout this crisis.
You’re still doing it now, misleading about infection risk from young children. Why should I believe you in relation to experimental vaccines?
Dr Michael Yeadon
The BMJ points out that the vaccine does not necessarily prevent transmission:
"None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus. The primary goal of a COVID-19 vaccine should be to keep people from getting very sick and dying, and second, to prevent transmission. Yet the current phase III trials are not actually set up to prove either". You can read the BMJ article here. (If it does not prevent transmission, and you still have to wear a mask and practice 'anti social distancing', why would you even bother getting it?)
The same article point out that only relative risk is being reported and even that is questionable as the data is not robust:
44,000 volunteers were recruited for the trials. Out of that number, 170 covid cases were recorded, 162 in the placebo group and 8 in the vaccine group. This is not 90% efficacy. The media are reporting RELATIVE risk and not ABSOLUTE risk which is actually less than 1% (BMJ).
And to qualify as a ‘case’, participants only had to display mild symptoms common to other seasonal illnesses, in combination with the flawed PCR test, “people with only a cough and positive laboratory test would bring those trials one event closer to their completion”
The dangers of coronavirus vaccine "disease enhancement due to pathogenic priming', also known as ADE.
Scientists first attempted coronavirus vaccines after the 2002 SARS-Cov outbreak.
Animals were given the most promising vaccines with good results as they developed an immune response, but when presented with the live coronavirus at a later date, they developed a hyper-immune response.
If non-neutralizing antibodies are produced instead of neutralizing antibodies, they will fail to neutralize the infectivity of the virus. It can also mean that a subsequent infection can elicit a more severe reaction to the virus. This is the reason why previous coronavirus vaccine trials failed. And this time, animal trials have been bypassed so the vaccines have not been tested for the possibility of ADE occurring. Described in detail here.
Another study states: “The role of autoimmunity in enhancing the severity of secondary exposures following prior infection or vaccinations has been given little consideration. In SARS, a type of “priming” of the immune system was observed during animal studies of SARS spike protein-based vaccines leading to increased morbidity and mortality in vaccinated animals who were subsequently exposed to wild SARS”. And it recommends that animal studies should be undertaken: “of course no vaccine against SARS-CoV-2 has yet been tested in animals and therefore we do not yet know if pathogenic priming is in fact expected. Such studies should be undertaken before use of any vaccine against SARS-CoV-2 is used in humans.”
Risks to fertility in women. The vaccinations are expected to produce antibodies against spike proteins of SARS-CoV-2. However, spike proteins also contain syncytin-homologous proteins, which are essential for the formation of the placenta in mammals such as humans. It must be absolutely ruled out that a vaccine against SARS-CoV-2 could trigger an imimune reaction against syncytin-1, as otherwise infertility of indefinite duration could result in vaccinated women. This has been raised by Drs Wodarg and Yeadon who filed an application with the European Medicine Agency responsible for EU-wide drug approval. The application now seems to have disappeared from the internet, however you can read about its contents here.
Adverse effects (to be continually updated)
So far, there have been various reported serious adverse effects, including two deaths announced by the FDA, four cases of Bell's Palsy and a number of allergic reactions. Anyone with allergies is now being advised not to have the vaccine. The allergic reactions apparently could be caused by the use of polyethylene glycol (PEG) according to this article by the Children's Health Defence. NHS England said in a statement that both of the medical workers who experienced anaphylactoid reactions to the Pfizer vaccine had a “strong past history of allergic reactions.” However, anyone with a history of severe allergic reactions was apparently excluded from the clinical trials so it's not clear why these volunteers were recruited.
There may be other adverse effects as the vaccine rollout continues and I will add them here if this is the case.
Dec 21st 2020: Article in Sciencemag.org discusses the severe allergy-like reactions in at least eight people who received the COVID-19 vaccine produced by Pfizer and BioNTech over the past 2 weeks.
It's probably worth also mentioning that they are still in the middle of 'human trials' and they will not be finished until 2022.