New coronavirus (COVID-19)

Updated 01 April 2020
Grafik af coronavirus

Read about the medicines agencies’ activities in relation to approval of a vaccine against COVID-19 and the supply of medicines and medical equipment in general.

Coronavirus (COVID-19) is a new virus, and there is as yet no vaccine for it. Medicines agencies around the world are therefore supporting researchers and companies in the speedy development of a COVID-19 vaccine, and preparing to execute the approval process as quickly as possible without compromising on safety.

As soon as a company believes that it is ready to have a vaccine approved, that company must submit documentation of the efficacy and safety of the vaccine to the authorities. For pharmaceutical countermeasures for communicable diseases, this process must be carried out in the European Union via a centralised application. This means that it must be approved by the European Medicines Agency (EMA), which approves the vaccine on behalf of all EU Member States.

For vaccines for particularly acute situations, such as this, it is possible to expedite the process. In such situations, the EMA offers the possibility of approval via the Emergency Authorisation Procedure, which results in conditional approval.  With the utilisation of a rolling review process, the application can be processed in approx. 70 days, compared the standard of 210 days. Through this process, the pharmaceutical companies submit their data to the EMA for evaluation as soon as they become available. This differs from the standard approval procedures, wherein the company submits all of its data all at once after the completion of testing. Assessments are then conducted continuously by a highly qualified panel of experts and in close collaboration with the health services in countries affected by the virus outbreak. When the vaccine reaches the market, continuous follow-up will be ensured regarding any adverse effects.

Supply of medicines and medical devices

Due to the extraordinary situation, new rules have been adopted, which means that companies, regions and municipalities may be ordered to report their supplies of medicines and medical devices to the Danish Medicines Agency, and that medicines and devices can be reallocated to those areas in the healthcare service and society that need them the most.

Protective equipment and medical devices

There are shortages of protective equipment, such as face masks, visors/shields and gowns, in several areas of the healthcare sector due to the worldwide increased demand caused by the corona pandemic. Since the outbreak of COVID-19, the Danish Medicines Agency has worked determinedly with companies, regions and municipalities to counteract the supply problems.

A collaboration with several of the biggest Danish companies has been formed to switch production to the manufacture of protective equipment.

To support the regions and the municipalities in the fight to procure sufficient supplies of protective equipment, a logistics centre has been established in the Danish Medicines Agency with a national overview of supplies in the regions and the municipalities. The centre will be the national coordination point for the distribution and reallocation of protective equipment and critical medical devices between the regions and the municipalities.

The Danish Medicines Agency has launched the Denmark helps Denmark campaign to get organisations, authorities, institutions and private companies to submit their ideas on how to procure extra protective equipment, COVID-19 test kits and hand sanitizer for frontline staff in the healthcare sector.

The general public and employees in the healthcare sector and all other sectors and companies have furthermore been advised to exercise prudent use of hand sanitizer and protective equipment and to only use the exact amount needed – no more no less.

Medicine

Even though there have not yet been reports of significant pharmaceutical supply problems caused by the COVID-19 pandemic, the authorities are planning and organising their work based on the assumption that such problems will arise. Supply problems may occur and the situation could worsen if devices and equipment are hoarded. The consequences in such a scenario will affect the groups in society with the greatest needs: the sick, the elderly, and the infirm. You should therefore not buy more medicine than you need.

Since the COVID-19 outbreak in China, a long line of initiatives have been launched in Denmark to counteract pharmaceutical supply problems.

Among other things, restrictions on the sale of OTC and prescription-only medicines have been introduced in Denmark. Wholesalers that procure medicines for pharmacies and hospitals are also working to adjust their stocks of vital medicines.


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