However, a number of medicines are being tested, and Norway is working in close collaboration with the EU to help ensure rapid development of medicines. The development of vaccines remains in the early stages.
The global medicine authorities are all in close dialogue with researchers and pharmaceutical companies that want to develop medicines, including vaccines, for covid-19. This also applies to the European Medicines Agency (EMA), with which Norway is affiliated. EMA is working closely together with the World Health Organization (WHO).
EMA has established a dedicated working group (the COVID-19 EMA pandemic Task Force (COVID-ETF)), which will be responsible for the rapid coordination of resources and provision of support to various research projects within the EU. In order to get covid-19 drugs and vaccines on the market as soon as possible, EMA can fast-track the regulatory timelines for the procedures at every stage until potential approval. Although EMA is establishing accelerated procedures, sufficient evidence of efficacy, safety and quality must still be provided.
Some of the procedures that have been fast-tracked are:
- Scientific and regulatory advice: EMA is offering research scientists and companies fast and free advice concerning appropriate methods and study design. The aim is to produce robust data concerning efficacy, safety and quality.
- Marketing authorisation applications
- Rolling review: evaluates data as it becomes available. Normally, when an application for a marketing authorisation is submitted, the data will be ready before the application is submitted. However with this procedure, data is reviewed in cycles, on an ongoing basis. When the data accumulated is considered to be sufficient, the developer can apply to EMA for a marketing authorisation. This procedure can be used when there is a serious threat to public health, such as a pandemic.
- Accelerated procedure: developer's application for a marketing authorisation is processed faster than usual (normally 210 days, can be reduced to less than 150 days).
The accelerated procedures are also available for drugs which already have a marketing authorisation for an indication other than covid-19, in cases where the investigator wishes to expand the existing indication. Read more about EMA's accelerated procedures.
Approvals (marketing authorisations) which are recommended by EMA are adopted by the European Commission and will also apply in Norway.
Testing should be conducted as clinical trials
Clinical trials involving large groups of patients are necessary in order to produce secure knowledge of how a vaccine/medicine works. EMA has recommended coordination of clinical trials in Europe. This implies that trial treatment within the boundaries of clinical trials should be prioritised rather than making medicines available via the compassionate use program (CUP), application for compassionate use, named patient or off-label use. With clinical trials, there is much more potential to collect research data about effect and safety.
The Norwegian Medicines Agency processes applications for clinical trials in Norway.
Applications relating to indications of covid-19 are prioritised and processed as quickly as possible. This also applies to CUP applications when the indications relate to covid-19. In some situations, rapid treatment is required for seriously ill patients and this is not possible within the boundaries of a clinical trial. In such an event, the Norwegian Medicines Agency will carry out a rapid assessment of applications for compassionate use, named patient.
Development and testing of vaccines and medicines
The development of vaccines for covid-19 started quickly, but is still in its early stages. It is difficult to say when a vaccine will be ready for use. The first trial started in March 2020, and several trials are in their start-up phase. It will take many months before any of the vaccines are ready for large-scale trials.
A number of existing medicines are currently being tested in relation to treatment for covid-19. These are used to treat other infectious diseases, such as HIV and malaria, or have been tested as treatment for Ebola and other coronaviruses. These clinical trials have, for the time being, produced few results.
When performing trial treatment, it is permitted to test completely new medicines without market authorisation or use medicines that have already been tested and approved for other diseases. Although the medicine may have been approved for other diseases, it is uncertain whether the same dosage and treatment regime can be used when testing the medicine with covid-19 patients. Other types of side effects may also emerge and at a different scope than previously identified.
Some of the medicines currently being tested in several major clinical trials are:
- Remdesivir – not approved, previously tested for Ebola
- Lopinavir/ritonavir – approved for treatment of HIV
- Chloroquine and hydroxychloroquine – approved for treatment of malaria and some autoimmune diseases
- Interferons, in particular interferon beta – approved for treatment of, e.g., multiple sclerosis
- Monoclonal antibodies that affect different components in the immune system
European Medicines Agency (EMA)
Update on treatments and vaccines against COVID-19 under development
Norwegian Institute of Public Health (FHI)
The amount of available research into covid-19 is increasing rapidly. The Norwegian Institute of Public Health has developed a systematic and living research map for covid-19 to help decision-makers, healthcare personnel, researchers and others navigate and utilise this research.
See the living map of covid-19 research
Danish Medicines Agency
The Danish Medicines Agency has an up-to-date list of ongoing trials of vaccines and medicines against covid-19:
The list shows the Danish Medicines Agency's provisional assessment of trials which, based on currently available information, are worth notice. Significant trials are marked in yellow. This means that the trials have been designed such that they potentially could provide important knowledge about the development of medicines against covid-19.