Swissmedic has begun the scientific assessment of the first COVID-19 vaccine. The application for authorisation was submitted at the beginning of October 2020 by AstraZeneca, the company that is developing the vaccine in partnership with Oxford University.
First application for authorisation of a COVID-19 vaccine in Switzerland submitted
The scientific assessment of the vaccine, currently bearing the designation COVID-19 Vaccine AstraZeneca, is undergoing what is termed a “rolling submission” procedure. This allows pharmaceutical companies to submit applications for COVID-19 medicinal products even before development work is concluded and prior to availability of the complete supporting documentation.
This procedure speeds up the process of deciding whether to authorise medicinal products: it enables Swissmedic to carry out the scientific assessment of non-clinical data from laboratory tests while clinical trials are still in progress. Trial results must then be submitted to Swissmedic for scientific review as they become available over the next few weeks and months.
However, no decision on authorisation can be taken until all the data needed to assess the safety, quality and efficacy of the vaccine have been submitted. The documentation must demonstrate how safe and effective the vaccine is in protecting humans against the new SARS-CoV-2 coronavirus.
Although Swissmedic is reviewing the dossier independently, it is working closely with partner authorities abroad on the scientific evaluation. Despite the high level of urgency, Swissmedic is reviewing the scientific data in accordance with its usual standards. Drug safety and the safety of the people who receive the vaccine are paramount.
Rolling submission is a special form of authorisation for new active substances that has been adopted in the current pandemic situation and is intended to facilitate faster authorisation of urgently needed medicinal products. Using the procedure, Swissmedic can review data from ongoing clinical trials as soon as it is available.
Applicants do not have present a complete dossier when they first submit their application. Instead, they submit an initial data package containing such data as is already available and give Swissmedic a timetable for subsequent data packages.
Swissmedic assesses the data packages as it receives them, and questions are sent to applicants with a short response deadline. Rolling submission enables Swissmedic to build up a picture of the vaccine’s risk-benefit profile even before the pivotal clinical trials have been completed.
Vaccine authorisations: prevention rather than cure
No medicinal product can be placed on the Swiss market until it has been the subject of an application for authorisation. Vaccines for the new SARS-CoV-2 coronavirus or medicines to treat COVID-19 are essentially subject to the same requirements as all other medicinal products.
The procedure for assessing applications for authorisation centres on the risk-benefit profile of the medicinal product in question. Since vaccines are generally administered to healthy people on a precautionary basis, the requirements they have to fulfil in terms of efficacy, safety and quality are extremely high – in accordance with international standards.