At the end of last week the pharmaceutical company Pfizer submitted an application for the authorisation of a vaccine against the SARS-CoV-2 virus. The vaccine candidate is based on the mRNA technology of the biotech company BioNTech. Swissmedic is now reviewing the active substance BNT162b2 in a "rolling submission" procedure. Swissmedic is fast-tracking all applications connected with the COVID-19 pandemic, assigning extra staff to this task so that content checks and, in particular, user safety are not compromised.
The Swiss therapeutic products agency reviews another vaccine in the rolling submission procedure
Swissmedic is also subjecting this authorisation application for a vaccine against the new coronavirus to a rolling review. This authorisation application concerns a so-called messenger RNA (mRNA), candidate. The mRNA components contain the blueprint for the new coronavirus. Human cells use this blueprint to simulate the spike protein that is characteristic of the SARS-CoV-2 virus, thereby tricking the human body into believing that it is infected with the SARS-CoV-2 virus. The immune system detects the foreign body and activates defence mechanisms such as the formation of antibodies. If the real coronavirus then enters the body of a vaccinated person, these newly formed antibodies detect the virus, activate the immune response system and neutralise the virus.
Ethical standards and scientific principles upheld
The criteria for reviewing safety, efficacy and quality remain unchanged, even in the face of the current pandemic situation. Claus Bolte, Head of the Authorisation Division, stresses: "The data packages for the vaccine candidates will be reviewed just as comprehensively, but faster. As a result, we can shorten the waiting times between the development stages during the review". Even for coronavirus vaccines, a decision on authorisation will be made only when all the data needed to assess the benefit-risk profile have been received and evaluated.