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The European Commission approved the Moderna vaccine for use in Europe and Norway yesterday (6 January). This is after it has been approved by the European Medicines Agency (EMA).
- I am glad that the second vaccine against Covid-19, the Moderna vaccine, has been approved by the European Commission on the recommendation of the European Medicines Agency. Thanks to cooperation with the EU on procurement, we will also have this vaccine for use in Norway. Thanks to the deliveries from Moderna, in addition to the vaccines we receive from BioNTech / Pfizer, we will eventually be able to offer even more vaccinations. This is Minister of Health and Welfare, Bent Høie, speaking.
Norway receives vaccines as part of EU cooperation.
- The EU has so far concluded an agreement with seven different vaccine manufacturers. If all these vaccines are approved, Norway will receive up to three times more doses than we need to vaccinate all our citizens. If there are no production and distribution problems, we will be able to offer the vaccine to all adults who want it before the summer, says Høie.
Vaccination in Norway will follow the order
The vaccine is approved for everyone 18 years of age or older. Vaccination in Norway will be held in accordance in order of priority of the National Institute of Public Health. Nursing home residents, risk groups over 85 years of age and selected groups of medical staff will be vaccinated first.
Norway gives priority to investing in a wide range of different vaccines
- For Norway and EU important was for the European Medicines Agency to thoroughly assess the effectiveness, safety and quality before vaccinations began. In line with the EU, Norway is prioritizing investment in the wide range of different vaccines that can be used. All this to be sure enoughthat at least one of the vaccine candidates will be successful. We expect to be able to obtain a large number of vaccines in the future. The countries that got vaccinated first, or used the fallback procedure before approval, have different laws than Norway and the EU, says Bent Høie.
The EU has an agreement for a total of 160 million doses from Moderna in 2021. Norway contributes almost 1,9 million doses. We will receive 67 doses of this vaccine in January and February, with larger shipments in the following months.
Drug approval. Norway participates on the same terms as the EU countries
Approval of a medicinal product means obtaining a marketing authorization, i.e. permission to sell the medicinal product. Vaccine approval in Europe is done jointly by pharmaceutical authorities within the EU/EEA. Norway participates on the same terms as EU countries in the European Medicines Agency EMA. The Norwegian Medicines Agency participates on behalf of Norway with representatives on EMA's scientific committees. EMA Committee for Medicinal Products for Human Use. Recommends the marketing of COVID-19 vaccines.Norwegian Institute of Health The public recommends which approved vaccines should be used in the national vaccination program.
The benefits of use must outweigh the risks of use.
In situations where there is a high unmet medical need, such as during a pandemic. The European Medicines Agency may recommend that the vaccine be approved before obtaining all the required documentation. This is called conditional approval (conditional marketing authorization), and it is an opportunity to ensure quick access to the vaccine during a pandemic. Conditional approval is given before long-term data on effects and side effects is available, and the authorization is valid once for one year. Nevertheless, the benefits of use must outweigh the risks of use. When complete data are available and still show a positive benefit-risk balance, the conditional marketing authorization can be converted into a simple approval.
