Paul-Ehrlich-Institut

Information on the Use of Cookies

In order to operate and optimise our website, we would like to collect and analyse statistical information completely anonymously. Will you accept the temporary use of statistics cookies?

You can revoke your consent at any time in our privacy policy.

OK

Eu­ro­pean Medicines Agen­cy (EMA) has start­ed Fourth Rolling Re­view of a COVID-19 Vac­cine Can­di­date for Eu­rope

On 12 February 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) started the fourth rolling review procedure for a COVID-19 vaccine for the EU – the evaluation of data successively submitted to accelerate the marketing procedure. CureVac’s vaccine candidate is called CVnCoV.

Persons check documents (Source: Aymanejed/Pixabay.com)

In the evaluation process for a vaccine for the European market by the European Medicines Agency (EMA), data on quality, safety and efficacy of vaccine products are tested by experts of the medicines agencies from the EU member states. CureVac's vaccine candidate is the fourth one subject to the rolling review procedure: this procedure serves to accelerate the evaluation of a COVID-19 vaccine candidate for a possible marketing procedure in time. The evaluation of data packages of the pharmaceutical and non-clinical development can be started before the complete clinical data are available for the formal marketing authorisation application.

The CHMP’s decision at the EMA to start the continuous evaluation of the data for CVnCoV is based on the preliminary results of laboratory studies and early clinical trials on adults. The studies show that the vaccine creates an immune response targeted against the coronavirus SARS-CoV-2.

The company is currently performing additional clinical trials to determine the safety and efficacy of the vaccine candidate. As soon as the data from this clinical trial and others are available, the CHMP will review these data and evaluate them with regard to their risk/benefit profile. The ongoing assessment of other data packages will be continued until all data required for a formal marketing authorisation application are available.

Background: The COVID-19 Vaccine CVnCoV from CureVac

Like the COVID-19 vaccines by BioNTech/Pfizer and Moderna, which have already been authorised in Europe, the vaccine candidate by the Tübingen based biotechnology company CureVac is an mRNA vaccine, too. The messenger RNA (mRNA) of the CVnCoV vaccine, which is in this case not modified by methylation, contains genetic information for the blueprint of the spike protein of the SARS-Coronavirus 2 of the predominantly circulating variants, which is stabilised in the prefusion conformation, encapsulated in small lipid particles. It mediates the uptake of mRNA in few human body cells, predominantly in the area of the injection. After the vaccination, the genetic information is read by the receiving body cells, the spike protein is produced and presented to the immune system. The immune system recognises the spike protein as foreign and, among other things, forms antibodies and T-cells, which are designed to confer protection from a symptomatic infection or a serious course of COVID-19.

Updated: 17.02.2021