European Commission authorises COVID-19 vaccine from Johnson & Johnson
On 11 March, the European Commission granted a conditional marketing authorisation for the COVID-19 vaccine from Johnson & Johnson. The authorisation is valid in Denmark and the rest of the EU.
On 11 March, the European Commission granted a conditional marketing authorisation for the vaccine from Johnson & Johnson, an American vaccine manufacturer. The vaccine has so far been 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 assessed that there are sufficient data on the vaccine’s quality, safety and efficacy and that the vaccine’s effectiveness in preventing COVID-19 outweighs the possible side effects.
Data on efficacy and side effects
The data on Johnson & Johnson’s vaccine come from clinical trials with more than 44,000 trial subjects divided into two groups. Half received the vaccine, and half (the control group) a placebo.
Data showed a 67% reduction in the number of COVID-19 cases in the group receiving the actual vaccine compared with those who received a different injection (the control group). A total of 116 trial subjects out of 19,630 in the vaccine group developed COVID-19 symptoms, whereas 348 trial subjects out of 19,691 in the control group got symptoms.
Side effects were also reported in the Johnson & Johnson study. Most 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 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.
Johnson & Johnson 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.
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:
European Commission’s press release
Danish Medicines Agency’s COVID-19 theme page
Danish Medicines Agency's theme page on COVID-19 vaccines