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  • Development and approval of coronavirus vaccine

Article

Development and approval of coronavirus vaccine

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.

Coronavirus vaccines with Norwegian marketing authorisation 

Vaccine

Manufacturer

Type of vaccine

Approved by European and Norwegian Medicines Agencies

Comments

Comirnaty

BioNTech og Pfizer

mRNA

Conditional approval  21.12.2020

 

COVID-19 Vaccine Moderna

Moderna

mRNA

Conditional approval  06.01.2021

 

Vaxzevria

AstraZeneca

Viral vector

Conditional approval  29.01.2021

Put on hold in Norway 11.03.2021

COVID-19 Vaccine Janssen

Jansen-Cilag International NV

Viral vector

Conditional approval  11.03.2021

Roll-out suspended in 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

19.04.2021: Added table about vaccines approved for use in Norway

15.04.2021: Added table with overview of vaccines authorised for use in Norway.

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