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The current data did not yet allow for a positive benefit-risk decision on the Swedish-British preparation, he said. Swissmedic first needs more information on safety, efficacy and quality from a phase III study that is ongoing in North and South America.
This mid-term evaluation is also supported by the external expert advisory committee of Swissmedic. As soon as the results of the study were available, “a temporary approval could be granted very quickly in the renewal process,” he said.
Wait for more data
On Tuesday evening, the Federal Commission for Vaccination Affairs (EKIF) had already recommended that more data be expected on the effectiveness of the Astrazeneca vaccine in different age groups, the vaccination schedule and the acceptance of the vaccine with a virus genetically modified.
The commission recommends that particularly vulnerable people – that is, people over 65 and patients with diseases that increase the risk of severe Covid-19, as well as healthcare workers – get vaccinated with only approved mRNA vaccines. and recommended for the moment.
Only to a limited extent in multiple countries
In Great Britain, the preparation, which Astrazeneca developed in conjunction with the University of Oxford, has been in widespread use since early January. In late January, the EU Medicines Agency (EMA) granted Europe-wide approval for the vaccine, for adults from 18 years of age with no age limit.
However, Italy, Germany, France and also Malta restricted the application. In Germany and France, the responsible vaccination commissions only recommend the drug for adults under 65, Italy and Malta only for patients under 55. The reason given was that there was insufficient data to guarantee its efficacy in older people. (pbe / SDA)
