Serious concerns were raised about the quality of his first batches Pfizer vaccine, as revealed by documents that came to light by the European Medicines Agency.
Scientists tasked with inspecting the vaccine for European approval have found that some doses were lower than promised by the drug giant.
In an email dated November 23, 2020, his top official European Medicines Agency warns of a “significant difference” in the quality of the vaccines sent to them by Pfizer, always in relation to what it had recruited for clinical trials.
The reason for the lower quality is unknown. As for its impact on the safety and efficacy of the vaccine, this “must be determined”, as the email.
Pfizer claims that these low-quality vaccines were not released in Europe.
In light of this finding, however, European officials submitted their “significant objections” to Pfizer before giving the green light.
The documents were leaked to the British Medical Journal after being hacked by the European Medicines Agency in December.
He found that only 55% of the vaccines that arrived in the European Union were stable and intact, compared to 78% shown by Pfizer studies.
The EU health regulator approved the Pfizer / BioNTech vaccine on December 21, saying its quality was “sufficiently consistent and acceptable.”
For the time being, it is not clear whether the European institution’s concerns have been met.
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