A document prepared for the FDA Advisory Committee meeting, in which members voted seventeen to zero in favour of giving emergency use authorisation for the administration of the Pfizer Covid-19 injection to children aged 5 to 11, confirms that Pfizer have modified the formulation of their injection for children to include an ingredient that reduces the acidity of blood and is used to stabilise people who have suffered a heart attack.
The FDA Briefing Document titled ‘EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 5 though 11 years of age‘ states the following on page 14 –
“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 phosphatebuffered saline (PBS) as used in the previous formulation and excludes sodium chloride and potassium chloride”.
EMERGENCY USE 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 authorisation 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 favour 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.