First COVID-19 vaccine authorised in the European Union

Updated 01 March 2021

The European Commission has granted a conditional marketing authorisation for the Comirnaty vaccine for COVID-19 from BioNTech/Pfizer. The authorisation is valid throughout the European Union including Denmark.

The European Commission has followed the recommendation from the European Medicines Agency’s (EMA's) expert committee CHMP to grant a conditional marketing authorisation for the COVID-19 vaccine from BioNTech/Pfizer. This means that the first COVID-19 vaccine has been authorised for use in Denmark and the rest of the European Union.

The conditional marketing authorisation has been granted because the CHMP has assessed that the documentation of the vaccine’s quality, safety and efficacy is sufficient to establish that the benefits of the vaccine in regard to COVID-19 prevention outweigh the risks in regard to unwanted side effects.

Documentation of efficacy and side effects in the BioNTech/Pfizer phase 3 trials

Since 5 October, when BioNTech/Pfizer started submitting data for assessment under a rolling review resulting in an application to the EMA on 30 November for the granting of a conditional marketing authorisation, the CHMP expert committee has been reviewing the extensive data from clinical trials, etc.

In the phase 3 trials, more than 36,000 trial subjects from different places around the world with high infection rates were randomly grouped in two equal halves; one half received the vaccine, the other a dummy injection (placebo). The trial then recorded how many in the two groups were infected with COVID-19.

The trial showed a 95% reduction in the number of COVID-19 cases in the group receiving the actual vaccine compared with those receiving a dummy injection. A total of 8 trial subjects out of 18,198 in the vaccine group developed COVID-19 symptoms, whereas 162 trial subjects out of 18,325 in the placebo group got symptoms.

As with all other vaccines, mild, transient side effects were observed during the trial. This is a sign that the immune system is reacting to the vaccine. More than 1 in 10 people thus reported to experience symptoms such as pain, headache and fever. Allergic reactions were also reported in a few trial subjects out of the 36,000 people. It is not unusual to see extremely rare allergic reactions to vaccines, and for this reason the COVID-19 vaccine from BioNTech/Pfizer, as well as any other vaccine, should be given under close supervision by relevant staff.

BioNTech/Pfizer is obliged to regularly submit data on efficacy and safety

Under a conditional authorisation, the vaccine manufacturer is obliged to submit further data to the EMA on an ongoing basis. A conditional authorisation is granted for one year and is subject to annual renewal. When the authorities have received all the agreed documentation, the conditional authorisation can be changed to a standard authorisation.

Vaccine procurement contract secures some 1.5 million vaccinations with the BioNTech/Pfizer vaccine for the Danish population

Denmark has entered into a vaccine procurement contract with BioNTech/Pfizer, securing the purchase of vaccines for about 1.5 million people and an extra half a million through a purchase option, if exercised. On 19 November, Denmark acceded to a contract which the European Commission had signed with BioNTech/Pfizer on behalf of the EU countries on 11 November.

More vaccines are likely to follow. Denmark has acceded to a total of six vaccine procurement contracts, which means that theoretically a total of 16 million people can receive a vaccine for COVID-19. However, this is only theoretically since it is neither certain that all vaccines are authorised nor that all options are exercised.

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