CureVac Swiss AG submits application for authorisation of COVID-19 vaccine (CVnCoV) to Swissmedic

Another COVID-19 vaccine under rolling review

19.04.2021

CureVac Swiss AG has submitted an application for the authorisation of its COVID-19 vaccine candidate CVnCoV to Swissmedic. This is the fifth authorisation procedure initiated in Switzerland for a vaccine against the SARS-CoV-2 virus.

With the rolling review procedure, Swissmedic evaluates the scientific data as soon as they become available and are submitted by the companies concerned. CureVac can forward documentation on its vaccine candidate on an ongoing basis without having to await the final results of the clinical trials.

Swissmedic is thus given an initial picture of the benefit-risk profile before the authorisation (Phase III) studies are completed. This procedure, which proved successful for the COVID-19 vaccines authorised to date, ensures that the requirements with regard to safety, efficacy and quality can be examined carefully and yet very swiftly. The duration of the rolling review will depend on the completeness of the data submitted by CureVac and the results of the clinical trials, and cannot therefore be predicted.

Including CureVac, five companies have now submitted applications for the authorisation of COVID-19 vaccines in Switzerland.

Authorisation applications for COVID-19 vaccines to date
Authorisation application Decision / status

6 October 2020
AstraZeneca COVID-19 vaccine (AZD1222)

Swissmedic starts rolling review of a COVID-19 vaccine

Still being processed / pending

Rolling authorisation application for COVID-19 vaccine: Swissmedic requests additional data

19 October 2020
Comirnaty® from Pfizer/BioNTech:

Swissmedic receives second application for the authorisation of a coronavirus vaccine

19 December 2020
Temporary authorisation

Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland

13 November 2020
Moderna COVID-19 mRNA vaccine

Swissmedic reviews vaccine candidate from Moderna

12 January 2021
Temporary authorisation

Swissmedic grants authorisation for the COVID-19 vaccine from Moderna

7 December 2020
COVID-19 vaccine from Janssen (Johnson & Johnson)

Janssen-Cilag AG applies to have its vaccine candidate authorised (swissmedic.ch)

22 March 2021
Temporary authorisation

COVID-19 vaccine from Johnson & Johnson: Swissmedic approves the third vaccine against COVID-19

15 April 2021
CureVac Swiss AG
 

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