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Development and approval of coronavirus vaccine
Several biotechnology companies, global vaccine manufacturers and other organisations are developing vaccines against COVID-19 disease.
Several biotechnology companies, global vaccine manufacturers and other organisations are developing vaccines against COVID-19 disease.
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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.
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Coronavirus vaccines with Norwegian marketing authorisation |
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Vaccine |
Type of vaccine |
Approved by European and Norwegian Medicines Agencies |
Comments |
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Comirnaty |
mRNA |
Standard marketing authorisation (16.09.2022) |
Vaccine against coronavirus - Comirnaty (BioNTech and Pfizer) |
| Comirnaty Original/Omicron BA.1 (BioNTech/Pfizer)
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Standard marketing authorisation (16.09.2022) |
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Comirnaty Original/Omicron BA.4-5 (BioNTech/Pfizer) |
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Standard marketing authorisation (16.09.2022) |
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Spikevax (Moderna) |
mRNA |
Standard marketing authorisation (16.09.2022) |
Vaccine against coronavirus - Spikevax (Moderna) |
| Spikevax Bivalent Original/Omicron BA.1 (Moderna) |
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Standard marketing authorisation (16.09.2022) |
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Nuvaxovid (Novavax) |
Subunit |
Conditional approval 20.12.2021 |
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Vaxzevria (AstraZeneca) |
Viral vector |
Conditional approval 29.01.2021 |
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Jcovden (Janssen-Cilag International NV) |
Viral vector |
Conditional approval 11.03.2021 |
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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
- Read more about the different vaccine technologies used in the development of coronavirus vaccines (Norwegian Medicines Agency)
Approval process
- Read more about the processes for approval of the vaccines (Norwegian Medicines Agency)