Development of vaccines and tests for SARS-CoV-2
5. Openness and flexibility of authorities
Aside from various forms of cooperation, accelerated and simplified procedures in the clinical phase also helped to speed up the review processes for the efficacy and safety of vaccines. Thanks to their openness to fast-track procedures, the authorities helped to ensure that the first vaccines were approved in record time. Despite the great urgency, safety (and efficacy) had and still have utmost priority. But producers were able to have various development processes running in parallel. This way, for example, different clinical trial phases could be combined. Pharmaceutical companies also recruited trial subjects simultaneously for different clinical trial phases. If one avenue of research proved unsuccessful, costly later clinical trial phases would have been redundant. The sharing of information between regulatory authorities was also stepped up and the approval process of Swissmedic was accelerated. Normally, the results of clinical phases I–III are collected and reviewed as part of the approval procedure. For an approval of vaccines against the coronavirus, however, individual studies were submitted to Swissmedic and reviewed in a rolling process. This delays in the process were avoided without any shortcuts when it came to safety.
The 30 years of experience in working with mRNA technology, the unparalleled international collaboration between the scientific community, pharmaceutical companies and biotech start-ups as well as the acceleration of regulatory procedures by the various authorities enabled vaccines to be developed in record time. But the pandemic has also shown us that, without the responsible use of animals, this would not have been possible.