Vaccines and medicines against COVID-19
The COVID-19 virus has spread to most parts of the world. COVID-19 is a novel type of virus from the same family as SARS and MERS. Worldwide clinical trials are currently testing new and old medicines that could perhaps be used against the disease.
As soon as a company believes it is ready to have a vaccine or medicine approved, it must submit documentation on the medicine’s efficacy and safety to the drug regulatory authorities. In the case of medicines for the treatment of infectious diseases, this is handled by the EU under the so-called centralised procedure. This means that the documentation must be submitted to the European Medicines Agency, EMA, which assesses the vaccine on behalf of all EU member states. If the EMA recommends approval, the European Commission subsequently issues a marketing authorisation in all EU member states.
Vaccines for emergency situations like this one can be reviewed under a special fast-track process. The procedure takes about 70 days compared to normally 210 days because a so-called rolling review is used. It is faster because the pharmaceutical companies submit their data to the EMA for assessment as soon as they become available. This is different from the normal approval procedure according to which the companies submit all data at once after all tests have been completed. The assessments are carried out continuously by a group of experts and in close dialogue with the health services in the countries affected by the virus outbreak. After marketing of the vaccine, a close follow-up procedure will be established to monitor potential side effects.
Studies and research on medicines for COVID-19
The Danish Medicines Agency is closely following worldwide studies and research on medicines for COVID-19. On this page in the box “worldwide studies of vaccines and medicines”, you can see the studies we have registered. The lists are currently updated.
Please be aware that these represent preliminary assessments of studies that based on the available information are worth noting. Significant studies are highlighted in yellow. This is to signify that we assess the studies to have been conducted in a way that they may potentially provide important knowledge in relation to the development of medicines for COVID-19.
Clinical trials in Denmark authorised under an accelerated procedure
Researchers in Denmark are busy too. Here on this page we will currently update a list of national clinical trials of medicines for COVID-19 that the Danish Medicines Agency has approved under an accelerated procedure as the trials were submitted to us. The review time has been reduced from normally 35 days to 3 days.
On the same subject:
| 02 July 2020 |
Last week, the EU countries and the European Commission published a European strategy to ensure citizens have swift access to a safe and effective COVID-19 vaccine. The Danish Medicines Agency participates as representative of Denmark in a European steering board that will be coordinating the joint procurement of vaccines.
| 26 June 2020 |
The European Medicines Agency has recommended granting a conditional marketing authorisation to Veklury, a remdesivir-containing product, for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. This will make Veklury the first medicine for COVID-19 that is authorised in the EU.
| 05 May 2020 |
| 07 April 2020 |