Freedom of Information request (FOI 22/1157)
Published 17 January 2024
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FOI 22/1157
7th December 2022
Dear
Thank you for your email.
The change from CMA to MA was done following the second annual renewal of Comirnaty, where no new data emerged that would alter the benefit/risk for these products. The CHMP concluded that the clinical safety profile, as well as the efficacy of this product, may now be considered comprehensively characterised, in the sense of the conditional marketing authorisation (CMA) legislation and the CMA converted to a full MA.
Further information is available from the EMA, see the link below:
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
With regards to data submitted since January 2021 for Comirnaty, these are available through the EMA repository, linked below:
https://clinicaldata.ema.europa.eu/web/cdp
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