Swissmedic reviewing AstraZeneca’s Covid-19 vaccine
Swiss drug authority Swissmedic has begun evaluating the so-called “Covid-19 Vaccine AstraZeneca”. It is the first time that a drugmaker has presented a coronavirus vaccine for approval in Switzerland.
This content was published on October 6, 2020 - 15:50AstraZeneca, which developed the vaccine in collaboration with the University of Oxford, submitted its application to Swissmedic at the start of this month.
The vaccine’s scientific evaluation will be done via a “rolling submission” process. This allows a pharmaceutical company to launch the application procedure before a product’s development is complete.
This “enables Swissmedic to carry out the scientific assessment of non-clinical data from laboratory tests while clinical trials are still in progress,” announced Swissmedic in a statement on Tuesday, noting that trial results must be submitted for scientific review as they become available over the next 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,” wrote the Swiss drug authority.
Swissmedic noted that while it is reviewing the vaccine independently, it is also working closely with partner authorities abroad. No medicinal product can go onto the Swiss market without Swissmedic’s approval.
