Adapted authorisation against virus variants can take place after a few weeks / We are prepared

"If an adaptation of the vaccines is necessary due to the new virus variant Omicron, the authorisation procedure in the European Union can be completed within a few weeks. No extensive new authorisation is required. The European Parliament, the Council of Ministers and the Commission have already ensured this by amending the law in spring this year. The EU's contracts already provide for the delivery of the adapted vaccine. We are prepared." This was stated by the health policy spokesperson of the largest group in the European Parliament (EPP-Christian Democrats), Dr. Peter Liese, on the occasion of reports according to which the effect of the vaccines approved in the EU might not be optimal with the Omicron variant.

The vaccine manufacturers Moderna and Biontech had recently made statements to this effect. "It cannot be assumed that the vaccines against Omicron are not effective at all. Although there are numerous mutations in Omicron the predominant sequences of the spike protein are also identical to the wild type from Wuhan, so that the vaccines will still work. It therefore makes sense in any case to get vaccinated now with the approved vaccines and also to do the boosting, as the adjustment will take some time and vaccination now will protect immediately in view of the high numbers of infections. However, it may make sense to adjust the vaccines to achieve a stronger effect than without adjustment. After all, the vaccines were developed on the basis of the original Wuhan type and are already no longer as effective against Delta as they were against the original type. As this development was foreseeable, we in the European Parliament, together with the Member States, already adopted a proposal of the European Commission for an accelerated approval procedure for adapted vaccines in March this year.

We are taking our cue from the flu vaccination, which also has to be adapted every year. According to this proposal, the companies do not have to submit completely new data sets. A so-called 'bridging study' is sufficient. The study must prove that the immune reaction to the mutated virus triggered by the variant vaccine is of the same magnitude as the vaccination reaction caused by the standard vaccine. The companies Moderna and Biontech are currently testing the effectiveness of their vaccines against Omicron. If this is significantly reduced, they will have to adjust the vaccine accordingly. Unfortunately, this will take a few weeks. The approval procedure can then go very quickly, so that from today's perspective, the complete process from the development of new vaccines to bridging study to approval can be completed in three to four months," Liese concluded.