Pfizer Continues to Use Babies and Children as Lab Rats to Develop More COVID-19 Vaccines – Petitions FDA for New EUA Booster for 5 to 11 Year Olds by Brian Shilhavy, Editor, Health Impact News
Pfizer and BioNTech announced today that they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.
They will also be making a submission to the European Medicines Agency (EMA) in the coming days.
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.
The request for Emergency Use Authorization of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies’ bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from the companies’ 10-µg bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from the companies’ Omicron BA.4/BA.5-adapted vaccine in their decision.
An application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine marketing authorization to include children ages 5 through 11 years will be submitted to the European Medicines Agency (EMA) in the coming days. (Source.)
The Press Release today also reported that they have begun Phase 1/2/3 studies on babies and young children aged 6 months through 11 years of age to test “the safety, tolerability, and immunogenicity of different doses and dosing regimens of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age.” (Source.)
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The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine was already authorized for adults over the age of 18 on August 31, 2022 without any human testing, so Pfizer is using babies and children as lab rats to conduct the first human tests on this new COVID-19 vaccine.
