Paul-Ehrlich-Institut

Eu­ro­pean Com­mis­sion Grants Mar­ket­ing Au­tho­ri­sa­tion for COVID-19 Vac­cine from Mod­er­na for the Eu­ro­pean Union

On 6 January 2021, the European Commission granted a conditional marketing authorisation (CMA) for Moderna’s COVID-19 vaccine. The Commission has thus followed the recommendation by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) of 6 January 2021. The authorised vaccine is called COVID-19 Vaccine Moderna and represents an mRNA vaccine. The marketing authorisation by the European Commission grants permission to market the vaccine in all member states of the European Union and to administer it in these countries. In Germany, an official batch release from the Paul-Ehrlich-Institut is required for the vaccine before it can be used.

EU flags in front of the European Commission building in Brussels (Source: NakNakNak/Pixabay.com)

On 6 January 2021, the Committee for Medicinal Products for Human Use (CHMP) at the EMA submitted a recommendation to the European Commission to grant a marketing authorisation for the COVID-19 vaccine from Moderna company. Based on the evaluation by the CHMP, the European Commission granted the marketing authorisation for the entire European Union after consultation with the member states in the Standing Committee for Medicinal Products for Human Use.

The COVID-19 vaccine developed by Moderna is intended for use in individuals 18 years of age and older. It contains 100 micrograms per dose of 0.5 milliliters of modified mRNA with the blueprint for the spike protein of SARS-coronavirus-2 stabilised in the prefusion conformation, mixed with lipid nanoparticles. Two vaccinations with this dose are scheduled at a time interval of 28 days. The safety of the vaccine was assessed in 15,185 vaccinated study participants, about 7,500 of whom were at least 65 years old. For efficacy, approximately 28,000 1:1 randomised study participants were followed for a median of 92 days. Here, an efficacy of 93.6 percent was determined, allowing for a time interval of 21 to 43 days.

Vaccines are currently the most effective means of containing the SARS-CoV-2 pandemic. Only the close world-wide cooperation of all experts contributing to the vaccine development has permitted more efficient processes without compromising the required care so that the marketing authorisation for the EU by the European Commission could occur at an earlier point in time. Scientists from the Paul-Ehrlich-Institut have contributed to accelerating processes through their early scientific and regulatory advice procedures. Furthermore, the institute is represented by an expert in the CHMP, thus contributing actively to the assessments in the various European marketing authorisation procedures.

In Germany, batches (production units) of the vaccine may only be marketed if they have been tested by the Paul-Ehrlich-Institut or another Official Medicines Control Laboratory (OMCL) in Europe and approved for Germany by the batch release of the Paul-Ehrlich-Institut. This ensures the quality of vaccine doses from each batch compliant with the marketing authorisation. Experimental testing of samples from each vaccine batch, conducted separately from the manufacturer, ensures that vaccine doses from each batch conform to the specifications set forth in the marketing authorisation.

Updated: 06.01.2021