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.

The press release and further information on this topic can be found on the Swissmedic website (see link below).

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.

The press release and further information on this topic can be found on the Swissmedic website (see link below).

Swissmedic starts rolling review of a COVID-19 vaccine