Regulatory Approval of the Pfizer vaccine - what does it say?

Let us go through what our Government has said about the Pfizer vaccine. The full document is here.


1. The opening paragraph:


"This medicinal product does not have a UK marketing authorisation but has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 16 years of age and over."


Well this is untrue straight away as the trials did not prove immunization in the slightest. Remember, the protocols are assessed with PCR tests, which prove absolutely nothing.


2. "Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. No data are available about concomitant use of immunosuppressants."


So, individuals with poorer immune systems may not benefit.


3. "Interaction with other medicinal products and other forms of interaction. No interaction studies have been performed."


One could argue this is what long term trials should be for? It seems awful risky to expose 7 billion people to a new experimental vaccine without seeing how it interacts with other medications as well as other vaccines. Thankfully, Pfizer advise not combining vaccines. Long term trials eh, who needs them?!


4. "It is unknown whether COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk. A risk to the newborns/infants cannot be excluded. COVID-19 mRNA Vaccine BNT162b2 should not be used during breast-feeding."


Pretty self explanatory I hope.


5. "It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility."


Pretty self explanatory. Note, this has not been publicised by media and is not included in the information sheet given to the patients, only the medical staff. You would think patients should be warned quite promptly and obviously.

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6. Here is a list of side effects experienced in the trials:


Adverse reactions reported in clinical studies are listed in this section per MedDRA system organ class, in decreasing order of frequency and seriousness. The frequency is defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).


Blood and lymphatic system disorders


Uncommon: Lymphadenopathy


Nervous system disorders


Very common: Headache


Musculoskeletal and connective tissue disorders


Very common: Arthralgia; myalgia


General disorders and administration site conditions


Very common: Injection-site pain; fatigue; chills; pyrexia 7


Common: Redness at injection site; injection site swelling


Uncommon: Malaise


Gastrointestinal disorders


Common: Nausea


This is copied and pasted word for word. Sounds like unnecessary experiences for a virus that our immune system handles at a better efficacy rate than this vaccine.


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7. "The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which MAY contribute to protection against COVID-19 disease."


Now Matt Hancock has expressly told us it will. Another lie?


8. "The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19 disease."


Wasn't helping the individuals with suppressed immune systems the point?


9. Only "21.8% were ≥ 65 years." Considering these are the most "at risk" there should probably more long term trials with the over 65s.


10. "Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 disease*. *Case definition (at least 1 of): fever, new or increased cough, new or increased shortness of breath; chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhoea or vomiting."


These symptoms could be linked to anything. It could have been the flu, a cold or whatever they want. PCR tests are trash.


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Well, these were the highlights. Read it yourself here.


Especially this part:


"At the time of the analysis of Study 2, information presented is based on participants 16 years and older. Participants had been followed for symptomatic COVID-19 disease for at least 2,214 person-years for the COVID-19 mRNA Vaccine and at least 2,222 person-years in the placebo group. There were 8 confirmed COVID-19 cases identified in the COVID-19 mRNA Vaccine group and 162 cases in the placebo group, respectively. In this analysis, compared to placebo, efficacy of COVID-19 mRNA Vaccine BNT162b2 from first COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior infection with SARS-CoV-2 was 95.0% (95% credible interval of 90.3% to 97.6%). In participants 65 years of age and older and 75 years of age and older without evidence of prior infections with SARS-CoV-2, efficacy of COVID-19 mRNA Vaccine BNT162b2 was 94.7% (two-sided 95% confidence interval of 66.7% to 99.9%) and 100% (two-sided 95% confidence interval of -13.1% to 100.0%) respectively. In a separate analysis, compared to placebo, efficacy of COVID-19 mRNA Vaccine from first COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior infection with SARS-CoV-2 was 94.6% (95% credible interval of 89.9% to 97.3%)."


I'm struggling to understand if there was even a statistical significant difference established between people with and without evidence of prior infection. However, I'm not sure I'm understanding the wording properly. Tell me if you know. The important thing is to realise they're measuring the results using PCR tests which are so unreliable, it is completely pointless (as Peter Doshi, associate editor at the BMJ agrees with.) The vaccine is "proven effective" if the participant presents a negative PCR test. That's hardly rock solid, rigorous testing. Look at my PCR test blog if you're interested.


As always, the "science" we're told to follow looks very weak and leaves more questions than answers. The fatality rate of this virus is now well under 1%. The second wave is nowhere to be seen (except on the TV screens and radio waves.) Our immune systems have a better efficacy rate. The protocols do not even prove reduction of transmission OR immunization. So it begs the question, why on earth do we need this vaccine? It's new technology, its experimental (as in, we are the experiment) and there is no long term testing. It doesn't sound like a great idea to me.


Get the vaccine if you want, but I think there is a bigger risk of unknowns within these vaccines than there is in getting sars-cov-2. At least think about it.



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Sources: Pfizer protocols - https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf


BMJ analysis of protocols - https://www.bmj.com/content/bmj/371/bmj.m4058.full.pdf


The Regulatory Approval by UK Government - https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/941452/Information_for_healthcare_professionals.pdf


Information for UK recipients (confirming those with low immune systems may not be eligible for the vaccine) - https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/940566/Information_for_UK_recipients_on_Pfizer_BioNTech_COVID-19_vaccine.pdf