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Swissmedic is reviewing the authorisation extension for a third dose of the COVID-19 vaccines from Pfizer/Biontech and Moderna

2021-09-16 16:45:08
newsbot by content-proivder.ch GmbH
Quelle: Swiss Federal Council

Bern, 16.09.2021 - Last week, the pharmaceutical companies Moderna and Pfizer submitted applications to Swissmedic, the Swiss Agency for Therapeutic Products, requesting a modification of the existing dosage recommendations for their COVID-19 vaccines, writes the Swiss Federal Council.

Swissmedic is examining the submitted data in the rolling review process. The COVID-19 vaccines from Moderna (Spikevax) and Pfizer/Biontech (Comirnaty®) are currently authorised in Switzerland for those aged 12 and over.

Both vaccines are administered in two doses.Swissmedic is reviewing the submitted clinical data on the third vaccine doses ("boosters") for safety and efficacy, and checking whether the submitted data are sufficient for extending the indication accordingly. Swissmedic prioritises all applications connected with the COVID-19 pandemic, without compromising on the content reviews.

When a decision can be made on the authorisation variations will depend on the submitted data and the results of clinical trials..

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Swissmedic reviewing authorisation extension third dose COVID-19 vaccines Pfizer/Biontech Moderna


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