Authorisation application submitted for the COVID-19 vaccine from Novavax
Bern, 14.02.2022 - Future Health Pharma GmbH has submitted an authorisation application to Swissmedic for vaccine candidate Nuvaxovid from Novavax. This is the first protein-based vaccine for which an authorisation application has been submitted in Switzerland.
Vaccine manufacturer Novavax does not have a place of business in Switzerland and therefore does not have an establishment licence. The pharmaceutical company has therefore decided to be represented in Switzerland for the authorisation application to Swissmedic by Future Health, which will act as the marketing authorisation holder after authorisation of the product.
Future Health submitted the authorisation application following authorisation of the vaccine by the European Medicines Agency (EMA). The application was submitted under the procedure according to Art. 13 of the Therapeutic Products Act (TPA). This enables Swissmedic to take the review by this authority into consideration.
The documentation submitted to Swissmedic must be identical to that on which the reference authority based its authorisation of the medicinal product. The assessment reports of the reference authority must also be submitted. The consideration of the results of foreign authorisation procedures is intended to help ensure that medicines that are already authorised abroad can be made available to patients in Switzerland as quickly as possible.
Nuvaxovid is a protein-based vaccine that contains the coronavirus spike protein. The human body recognises that this is a foreign substance. In response, the immune system produces antibodies and is therefore better equipped to tackle a possible infection. The vaccine can be stored for up to six months in conventional refrigerators, which is beneficial from a logistics perspective in particular.
To date, Swissmedic has approved the Pfizer/BioNTech (Comirnaty), Moderna (Spikevax) and Johnson & Johnson (COVID-19 Vaccine Janssen) vaccines in Switzerland.
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