Rolling authorisation application for COVID-19 vaccines Swissmedic requests additional data
Bern, 03.02.2021 - Swissmedic examines the data on the vaccine from AstraZeneca it receives on an ongoing basis 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.
To obtain a conclusive assessment, the applicant will among other things have to submit additional efficacy data from a Phase III trial under way in North and South America, and these will have to be analysed. As soon as the results have been received, a temporary authorisation according to the rolling procedure could be issued at very short notice.
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Swissmedic
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Swiss Agency for Therapeutic Products
http://www.swissmedic.ch/?lang=2
