Why Has Pfizer Changed The Formulation Of Its Covid-19 Vaccine For Children?
Their formulation was changed to include an ingredient that allegedly stabilizes people suffering a heart attack. But the real question is – why would kids need something like that?
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A document prepared for the FDA Advisory Committee meeting, in which members voted seventeen to zero in favor of giving emergency use authorization for the administration of the Pfizer Covid-19 injection to children aged 5 to 11, confirms that Pfizer has modified the formulation of their injection for children to include an ingredient that reduces the acidity of the blood and is used to stabilize people who have suffered a heart attack.
“Authorization is being requested for a modified formulation of the Pfizer‑BioNTech COVID-19 Vaccine. Each dose of this formulation contains 10 μg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 that is formulated in lipid particles and supplied as a frozen suspension in multiple-dose vials.”
“To provide a vaccine with an improved stability profile, the Pfizer-BioNTech COVID-19 Vaccine for use in children 5-11 years of age uses tromethamine (Tris) buffer instead of the phosphate-buffered saline (PBS) as used in the previous formulation and excludes sodium chloride and potassium chloride”.
Emergency use was immediately granted!
“The Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Pfizer’s COVID-19 vaccine for children aged between 5 to 11 years old on October 29th, 2021. The authorization was based on what the FDA believes was their “thorough and transparent evaluation of the data” which included input from independent advisory committee experts, and the vote was overwhelmingly in favor of making the vaccine available to all children in this age group.
However, with overwhelming evidence against the safety of the vaccine and now a change in the formula used in clinical trials EUA should never have been granted.”
Though – trials were inadequate and insufficiently supported.
“The FDA had addressed this earlier in the year and asked Pfizer to expand the clinical trials, nevertheless, this had not happened., Pfizer just ignored them and instead “fudged it by importing data from a different study” according to the experienced risk and benefit analyzer Toby Rogers PhD.
In his article, “Ten red flags in the FDA risk-benefit” Toby Rogers simplified, “if the rate of particular adverse outcome in kids as a result of the vaccine is 1 in 5,000 and the trial only enrolls 1,518 in the treatment group then it is unlikely to spot this particular harm in the clinical trial”.
