European Commission authorises one more COVID-19 vaccine

On 6 January 2021, the European Commission granted a conditional marketing authorisation for the COVID-19 vaccine from Moderna. The vaccine has demonstrated a 94 per cent efficacy in trials. The authorisation is valid throughout the European Union including Denmark.

Yesterday, the European Commission granted a conditional marketing authorisation for the vaccine from Moderna. The vaccine is authorised for the prevention of COVID-19 in people from 18 years of age. The conditional authorisation has been granted based on the recommendation from the European Medicines Agency, EMA, which has assessed that there is sufficient data on the vaccine’s quality, safety and efficacy and that the vaccine’s effectiveness in preventing COVID-19 outweighs the risks in the form of side effects.

Since mid-November, experts from the EMA have reviewed Moderna’s extensive data on the vaccine’s efficacy, side effects and quality. With participation from the Danish Medicines Agency adds Thomas Senderovitz, Director General of the Danish Medicines Agency:

“Our people have been deeply involved in the assessment of the Moderna vaccine, so we have helped ensure that the data have been thoroughly reviewed. The pace at which the vaccine has been developed and authorised is unprecedented, but we stand firm that we mustn't rush things. And we haven’t with the Moderna vaccine,” said Thomas Senderovitz.

Data on efficacy and side effects

The data on the Moderna vaccine come from clinical trials with around 30,000 trial subjects allocated in two groups. Half received the vaccine, and 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.

Side effects were also reported in the Moderna study. They were mild and transient in nature. Such side effects 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.

Moderna to regularly submit information on efficacy and side effects

A conditional marketing authorisation is granted for one year and is subject to annual renewal. The authorisation requires the vaccine manufacturer to regularly submit data on efficacy and side effects to the EMA. When the authorities have received all the agreed documentation, the conditional authorisation can be changed to a standard authorisation.

Apart from the Moderna vaccine and the vaccine from Pfizer/BioNTech, which began its roll out in Denmark on 27 December 2020, Denmark has entered procurement contracts with four other vaccine manufacturers.

Further reading: Danish Medicines Agency’s theme page on COVID-19 vaccines (in Danish only)

 

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