COVID-19 vaccine: Swissmedic requests additional data on the vaccine from AstraZeneca
5. Februar 2021 – At an extraordinary meeting on 2 February 2021, the external Swissmedic advisory body HMEC (Human Medicines Expert Committee) decided that regarding the application for the authorisation of the AstraZeneca vaccine “COVID-19 Vaccine AstraZeneca” (AZD1222), the data submitted and analysed so far are not yet sufficient to permit authorisation. The data currently available do not point to a positive decision regarding benefits and risks. To obtain a conclusive assessment, the applicant will among other things have to submit additional efficacy data from a Phase III trial currently ongoing in North and South America.
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