Swissmedic grants temporary authorisation for the Nuvaxovid COVID-19 vaccine from Novavax

Bern, 09.03.2022 - Swissmedic has authorised the Nuvaxovid vaccine from manufacturer Novavax for people aged 18 and over. According to the documentation assessed by the Swiss Agency for Therapeutic Products, the level of protection afforded seven days after the second dose of the vaccine is approximately 90 percent. This is the fourth COVID-19 vaccine to be authorised in Switzerland.

Novavax does not have a place of business in Switzerland and therefore does not have an establishment licence. The pharma company’s application for authorisation was therefore submitted by Future Health Pharma GmbH on 14 February 2022. Accordingly, this company will also be the marketing authorisation holder in Switzerland following the positive decision. Future Health Pharma GmbH submitted the application according to Article 13 of the Therapeutic Products Act. The article states that the results of foreign authorities’ assessments may be factored into the review.

Based on the assessment of the evaluation results and the positive decision of the European Medicines Agency of 20 December 2021, Swissmedic has granted temporary authorisation for the protein-based vaccine Nuvaxovid for people aged 18 and over. The data showed high efficacy in the investigated age group and met the safety requirements. Nuvaxovid must be administered in two doses three weeks apart. The vaccine can be stored in the refrigerator for up to nine months.

Unlike the mRNA vaccines from Pfizer/BioNTech and Moderna and the viral vector vaccine from Johnson & Johnson, Nuvaxovid is a protein-based vaccine. It contains a non-infectious component from the surface of the SaRS-CoV-2 virus which triggers a protective immune response when the body’s immune cells come into contact with it. The vaccine contains an adjuvant to strengthen the immune response.

With this authorisation of the Nuvaxovid vaccine, Swissmedic has now approved the fourth application for a COVID-19 vaccine. The vaccines from Pfizer/BioNTech (19 December 2020), Moderna (12 January 2021) and Johnson & Johnson (22 March 2021) have already been approved.

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