Freedom of Information request on the regulatory approval on the Pfizer/ BioNTech COVID-19 vaccine (FOI 21/1025)
Published 25 February 2022
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28th September 2021
FOI 21/1025
Dear
Thank you for your email.
As per the Summary of Product Characteristics (which can be found in the link below), one dose of the vaccine contains ‘30 micrograms of COVID-19 mRNA Vaccine (embedded in lipid nanoparticles)’.
The published Public Assessment Report (PAR) and EPAR lists the parameters used in the control of the drug product. They can be found at the following links:
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
The parameters and their acceptance criteria described in the drug product specification provide sufficient assurance of the consistency of every dispensed dose in terms of LNP size, numbers of LNP particles and mRNA content so that these parameters will have no impact on established safety and efficacy of the vaccine in use.
Please note, the acceptance criteria are confidential information.
If you have a query about the information provided, please reply to this email
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