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Swissmedic is lowering expectations for rapid corona vaccines in Switzerland: “Early vaccines are not a solution for Switzerland,” said the therapeutics authority. She is responsible for the approval of vaccines.
This also means that there is no emergency permit for vaccines in Switzerland. This would allow funds to be brought to the market while authorization requests are still being processed. In other countries, such as the USA, the competent authority may issue such emergency approvals.
Accelerated and more personal processing
An emergency permit for vaccines is simply not legally allowed in Switzerland. But that does not mean that the Swiss do not prioritize the approval of a vaccine as important as Corona.
“Swissmedic is handling all requests related to the Covid-19 pandemic faster and with more staff,” the message reads.
The approval of a Covid 19 vaccine will be differentiated, he said. As with any drug approval, restrictions may initially be placed on certain ages or risk groups if these groups were not sufficiently represented in clinical trials.
No vaccines without completed authorization requests
In fact, Swissmedic is exchanging information with authorities in other countries that have already approved the vaccine. Furthermore, manufacturers’ data is constantly sent to Swissmedic. This is what is known as a “continuous procedure,” according to Swissmedic.
A vaccination authorization can be issued faster than usual. But the difference with an emergency approval is that all testing procedures must be completed. Sufficient data on safety, efficacy and quality must be available and verified. “As soon as the data allows an initial risk-benefit assessment, Swissmedic will make a very quick decision on approval,” says Raimund Bruhin, Director of Swissmedic.