MRHA Approval of the Pfizer Vaccine: what you need to know

Some interesting insights from the super fast UK MHRA temporary approval of the Pfizer #covid vaccine👇🏼

SAFETY:

🔸 The safety conclusions have been made from a mere 2 months of data post the second dose for only 19,067 vaccinated participants.

🔸 The study has not looked to assess adverse interactions with other medicines someone may be taking. How many first in line for vaccines will be on a multitude of meds? 

🔸 Animal reproductive and development toxicity studies have not been completed – either in animals or humans. I.e. there is no means to understand if this vaccine could have an adverse effect to fertility, pregnancy, baby development or breast milk contamination.

🔸 57.2% (10.9K) were aged 16-55 years, 20.8% (4K) were aged 55-64 years, and 21.8% (4.2K) were ≥ 65 years. 

🔸 The study EXCLUDED participants who were immunocompromised. How many first in line for the vaccine will have compromised immune systems?

🔸 The study EXCLUDED those who had previously COVID-19, so there is no understanding of what reaction they might have.

🔸 Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalisation 6 weeks before enrolment, were included.

🔸 The most common adverse reactions include pain at the injection site (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 30%), chills (> 30%), arthralgia (> 20%) and pyrexia (> 10%). Is states that these events were USUALLY mild or moderate in intensity and resolved within a few days.

COMMON ADVERSE REACTIONS:

Very common: may affect more than 1 in 10 people:

» pain at injection site
» tiredness
» headache
» muscle pain
» chills
» joint pain
» fever

Common: may affect up to 1 in 10 people:

» injection site swelling
» redness at injection site
» nausea

Uncommon: may affect up to 1 in 100 people:

» enlarged lymph nodes
» feeling unwell

EFFICACY:

🔹 Within a max period of 2 months after 2nd dose:

• 8 people in the vaccinated group had confirmed COVID-19*
• 162 people in the placebo group had confirmed COVID -19*

 * Case Definition – determined by PCR and at least 1 symptom consistent with COVID-19 disease. Symptoms to be 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.

  👆🏼Shame Govts around the world don’t use this case definition. 🤔

🔹 There was no Challenge Response – i.e people were not given lab cultured SARS CoV2 to clinically control the variables and take accurate measurement of disease manifestation. Why not?

🔹 Instead, participants were asked to report symptoms should they suspect *wild* SARS CoV2 infection, and the lab would then conduct a PCR test and confirm symptom(s) presence.

🔹 No antibody of T-cell seroprevalence was conducted prior to vaccination, no seroprevalence data has been considered in the MHRA analysis, and no antibody or T-cell measurement is formally referenced in the Phase 2/3 measurable outcomes.

  👆🏼So why the obsession about antibodies if Phase 3 Vaccine trials don’t test and report on the before/after picture to measure effectiveness? 🤔

🔹 MHRA deduced 95% effectiveness by simply calculating 9/170. I.e. 5% of the confirmed wild cases were observed in the vaccinated group.

  👆🏼One would assume effectiveness is the % of protection that is clinically observed when challenged with the SARS CoV2 virus. That is NOT what it means. 🤔

🔹 There were no clinical controls implemented to ensure this was a scientifically sound experiment. 

🔹 This study, across multiple cities in the US, Argentina, Brazil, Germany, South Africa and Turkey, had no control over the participants in terms of community virus prevalence, their behaviours, who they interacted with, social distance monitoring, what level of protection they took, level of hygiene, nutrition or exercise, stress, or any other behaviour.

🔹 It is not declared where these confirmed Vaccinated and Placebo cases lived, what the respective SARS CoV2 presence was for each, and whether there was a cluster of cases in one predominately placebo controlled region.

  👆🏼Why not? Is there a pattern we should be made aware of? 🤔

–

VERY IMPORTANT:

‼️ Placebo participants can choose to be unblinded and have the COVID-19 vaccination, and this is a supported action by the manufacturer. In doing so, the control arm for safety monitoring will end, preventing full two surveillance for adverse reactions or vaccine-induced health/function decline.

‼️ This temporary MHRA approval does not have nay termination period. IT will be revoked once (if) Market Authorisation is received post full study completion.

‼️ As per the tradition with emergency use authorisation and biologics approvals for nation state use, there is no safety or efficacy liability imposed on the manufacturers – in this case Pfizer and BioNTech.

#AllTheFacts #DoYourOwnResearch

____

SOURCE:

Gov/MHRA documentation as well as Clinical Trial design listed in the below comment 👇🏼

• GOV/MHRA PFIZER APPROVAL DOCUMENTATION
• PFIZER VACCINE CLINICAL TRIAL DESIGN (look just at Phase 2-3 measures and criteria)

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