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Article

Development and approval of coronavirus vaccine

Published Updated

Several biotechnology companies, global vaccine manufacturers and other organisations are developing vaccines against COVID-19 disease.

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Several biotechnology companies, global vaccine manufacturers and other organisations are developing vaccines against COVID-19 disease.


Development

Major resources have been invested to develop good vaccines against coronavirus. Several vaccines are under development and some have been approved by the medicine authorities. 

Approval

Although the medicines agencies in Europe and Norway are facilitating the rapid development and approval of coronavirus vaccines, the strict requirements for quality, efficacy and safety must still be met. A vaccine is only approved if the benefit is considered to far exceed the risk.

The coronavirus vaccine Comirnaty from BioNTech and Pfizer was the first coronavirus vaccine to receive conditional approval from the European Medicines Agency (EMA) and the European Commission. The approval granted on 21 December 2020 applies to the EU / EEA and includes Norway.

The conditional approval granted to the coronavirus vaccine COVID-19 Vaccine Moderna on 6 January 2021 also applies to the EU / EEA and includes Norway.

The vaccines have been tested in large studies where several thousand people have received them. The studies have been carried out in the same way as for other vaccines, but the observation time is shorter. Conditional approval means that there are enough data to assess that the benefit of the vaccine is far greater than the risk, but that the vaccine manufacturer must continue the studies and continuously provide the medicine agencies with data that become available.

The Norwegian Medicines Agency assesses the clinical documentation and approves vaccines for use in Norway, in collaboration with the European Medicines Agency. Several coronavirus vaccines are expected to be approved.

Vaccine technologies

Approval process

History

18.01.2021: Minor updates to the article.

21.12.2020: Updated information about approval

23.10.2020 Shortened text and added links to expanded information at Norwegian Medicines Agency

12.10.2020 Minor updates based on current knowledge. Link to Norwegian Medicines Agency

 

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