Statement of the GfV on the central and exclusive procurement of the COVID-19 vaccine from Pfizer/BioNTech by the German government from 2024 to 2026

Due to the central and exclusive procurement of the Pfizer/BioNTech mRNA vaccine by the German government from 2024 to the end of 2026, other vaccines can no longer be administered from the 2024/25 vaccination season without fear of recourse, although they are recommended by the STIKO as equivalent. This is explained by the economic efficiency requirement in accordance with Section 12 SGB V. This means that in practice there is no longer a free choice of vaccine. We consider this to be extremely questionable, both with regard to freedom of choice and freedom of therapy as well as with regard to Germany as a center of science.

The availability of different vaccines and platforms has always been an important component of the COVID-19 strategy since the beginning of the pandemic. The fact that only one vaccine will be available in practice from the 2024/25 vaccination season onwards is causing a lack of understanding among patient support groups and doctors alike. Patients who did not tolerate the last mRNA vaccination well will no longer be offered an alternative from this point on. Doctors will no longer be able to provide individualized vaccination advice with regard to pre-existing conditions and allergies - an mRNA vaccine is not an option in the case of a PEG allergy, for example. This makes it more difficult to convince high-risk patients of the need for vaccination. Negative effects on the already comparatively low vaccination rate in Germany are to be feared: According to a recent survey, only 46% of the main target group of over 60-year-olds want to refresh their vaccination protection against COVID-19. In order to achieve higher vaccination rates, the widest possible selection of vaccines and platforms is needed.

The exclusive procurement of a vaccine by the German government is also questionable from a research perspective, as it means that only Pfizer/Biontech-based real-world data can be collected from the 2024/25 vaccination season onwards. This means that comparative studies can no longer be carried out, which means, among other things, that it will no longer be possible to gain new insights into heterologous vaccination in Germany. It is precisely in this area that German research has made a decisive contribution to global knowledge in recent years.

The Federal Government's decision also means that here in Germany we are deprived of the opportunity to learn more about side effects, especially serious side effects, of the individual vaccines. In the case of mRNA vaccines, we have seen that serious side effects, for example in the cardiological field, occur very rarely but must be taken seriously. We are therefore concerned that it will no longer be possible to collect comparative side effect data in Germany from the 2024/25 vaccination season. Such data would show whether other COVID-19 vaccines such as protein-based vaccines, which have already been used for many years against various other viruses (influenza, hepatitis B or HPV) and have a favorable safety profile, have less severe side effects. This is also not a good signal for patients who have already experienced such side effects.

The loss of numerous opportunities to generate comparative data also means that no studies showing efficacy and immunogenicity data of other vaccines versus new variants can be carried out in Germany. As a result, research projects in this area, insofar as they depend on such data and studies, are also at risk. This creates a climate in the field of vaccine research that is not conducive to innovation and makes Germany less attractive to other manufacturers. This applies not only to the development of future variant-adapted vaccines, but potentially also to innovative research areas such as combination vaccines (influenza plus COVID-19).

The Federal Government's efforts to provide sufficient vaccines for the population should be emphasized positively. For the reasons mentioned, we are now calling on the government to create the conditions in this effort to ensure that, in addition to Pfizer/BioNTech, the other COVID-19 vaccines recommended by STIKO - i.e. as things stand today, the adapted vaccines from Moderna and Novavax - are available in sufficient quantities and can also be administered from the 2024/25 vaccination season without fear of recourse. It's about freedom of choice, it's about freedom of therapy, and it's about diversity, which is essential for research and science.

The Board of Directors and the "Immunization" Commission of Society of Virology e.V.