EMA recommends conditional authorisation of the COVID-19 vaccine from Moderna

The European Medicines Agency, EMA, has recommended the European Commission to grant a conditional authorisation for the COVID-19 vaccine for use throughout the European Union, including Denmark. 

The first citizens in Denmark have received vaccination against COVID-19 with the Pfizer/BioNTech vaccine, which was authorised by the European Commission on 21 December 2020 for use throughout the European Union including Denmark. Now, the European Medicines Agency, EMA, has recommended the European Commission to also grant a conditional authorisation for the COVID-19 vaccine from Moderna.

The European Commission is now processing the recommendation. If a conditional authorisation is granted, it becomes valid throughout the European Union including Denmark like the BioNTech/Pfizers vaccine.

A conditional authorisation means that the medical experts of the EMA have assessed that the documentation of vaccine efficacy and safety is sufficiently solid, and that the benefits of making the vaccine available to people fast outweigh the theoretical risks of not having the same amount of long-term data as in a standard authorisation procedure.

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.

Authorisation basis: Vaccine trials establish a 94 per cent efficacy

Since mid-November, a group of experts from the EMA has reviewed Moderna’s extensive data that account for the vaccine’s efficacy and side effects. The documentation includes data from clinical trials with around 30,000 trial subjects allocated in two groups. Half received the vaccine; half were given a dummy injection (placebo).

The trials showed a 94 per cent reduction in the number of COVID-19 cases in the group receiving the actual vaccine compared with those receiving a placebo. A total of 11 out of 14,134 trial subjects in the vaccine group developed COVID-19 symptoms, whereas 185 out of 14,073 trial subjects in the placebo group got symptoms. 

The study also showed a 91 per cent efficacy in trial subjects at risk of developing severe COVID-19 symptoms, including those with lung disease, heart disease, obesity, liver disease, diabetes or HIV infection.

As with all other vaccines, mild, transient side effects were observed during the Moderna trial. These are signs that the vaccine is working because the body is reacting to the vaccine entering the body. The trial subjects most commonly reported transient reactions such as pain or swelling at the injection site, tiredness, headache and fever.

The safety and efficacy of the vaccine will be monitored on a continuous basis as the vaccine is rolled out in Denmark and the rest of the European Union.

Further reading:

EMA’s press release:  EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU.

Danish Medicines Agency’s theme page on COVID-19 vaccines