Rolling authorisation application for COVID-19 vaccines Swissmedic requests additional data

Swissmedic examines the data on the vaccine from AstraZeneca it receives on an ongoing basis
03.02.2021
Swissmedic is currently reviewing two applications for the authorisation of COVID-19 vaccines. With regard to the AstraZeneca vaccine, the data submitted and analysed so far are not yet sufficient to permit authorisation. To obtain more information about safety, efficacy and quality, additional data from new studies are needed.
Swissmedic is currently reviewing two applications for the authorisation of COVID-19 vaccines in the rolling review procedure, including the application for the authorisation of the “COVID-19 Vaccine AstraZeneca” (AZD1222) for the coronavirus. At an extraordinary meeting on 2 February 2021, the external Swissmedic advisory body HMEC (Human Medicines Expert Committee) confirmed Swissmedic’s interim assessment of the AstraZeneca coronavirus vaccine based on the data analysed to date. The data currently available do not point to a positive decision regarding benefits and risks.
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