Third coronavaccin gets rapid review by EMA

The European Medicine Agency EMA has launched a rolling review for the coronavaccin developed by the pharmaceutical Moderna. In a rolling review, the results of a survey are assessed extra quickly.

Normally, pharmaceuticals do not submit the results of their vaccine studies to the authorities for evaluation until they have completed all the studies. In exceptional situations, pharmaceuticals may request a rolling review, sharing interim results with the authorities.

This does not change the requirements that vaccines must meet, but the authorities may rather form a judgment. โ€œOutside coronatijd, an assessment can take a year and a half. The duration of this procedure depends on the quality of the research data and whether we have additional questions,โ€ says a spokesman for the Evaluation of Medicines (CBG). โ€œEarlier this year, the inhibitor inhibitor inhibitor inhibitor was accelerated, and EMA succeeded in four weeks.โ€

The study by the American pharmaceutical company Moderna is now in phase 3; the phase in which it is necessary to determine whether the vaccine is protecting people from the disease covid-19, and 30,000 people are involved in this study. Half of them are given two doses of the vaccine MRNA-1273, the other half is given two placebos.

Possible 160 million doses

The Moderna vaccine is one of the six vaccines reserved by the European Union negotiating team. There are 80 million doses reserved and there is an option to scale up to 160 million doses. If the EEA finally judges positively on the vaccine, the European Commission may grant an authorisation.

Previously, the EMA announced rapid assessment procedures for the vaccine from AstraZeneca and the University of Oxford and for the vaccine from Pfizer and BionTech. Of that last vaccine, the producer claimed last week, based on interim results, that it would be 90 percent effective.