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August 31, 2022 FDA approves
bivalent vaccine on “faith” not
data
On August 31, 2022 the FDA announced the emergency use authorisation of the new COVID-19 bivalent booster vaccine formulations both Moderna and Pfizer-BioNTech with NO human trials and NO advisory panel consultation. The formulation contains the mRNA spike protein code for the extinct original Wuhan strain plus “one in common between [!!!] the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2″. They will be referred to as “updated boosters” [1, 2]
“The company has tested the BA.5-specific vaccine only on [eight] mice, so far, and is relying on data from both the BA.1 human trials and the BA.5 mice trials for their submission for authorisation”. A vaccine expert John Moore says “to rely only on mouse data (for authorisation) would be unprecedented“! But both of these vaccines do not contain the mRNA code use in this new EUA
FDA Commissioner Robert Califf tweeted, “As we know from prior experience, strain changes can be made without affecting safety.” He is considering this new technology vaccine the same as an influenza “strain change“, but is ignoring the trail of destruction.
The Moderna BA.1 vaccine was authorised in the UK on August 15, 2022
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