Vaccines to prevent COVID-19 are considered game changers in the fight against the corona pandemic. The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, has taken early action to accelerate the development and authorisation of COVID-19 vaccines without compromising their safety and efficacy. At this year's meeting with the German Association of Research-based Pharmaceutical Companies (vfa) on 23 September 2020, approaches to further optimise the approval processes for vaccines and therapeutic biomedicines were discussed. Other topics were the security of the supply of vaccines, the protection against counterfeiting of pharmaceuticals and the legally strengthened interaction between risk-benefit assessment during authorisation and additional benefit assessment after authorisation. Possibilities of digitising summaries of product characteristics (SmPC) and Red-Hand letters as well as electronic submission options for applications for approval of clinical trials were also discussed and found joint support.
The process of vaccine development itself cannot be accelerated, but organisational and information processes can be continuously improved. To this end, a dialogue with pharmaceutical and biotech companies is indispensable. At the virtual meeting, experts from the Paul-Ehrlich-Institut discussed further optimisation of the development, authorisation and approval process with representatives of the German Association of Research-Based Pharmaceutical Companies (Verband Forschender Arzneimittelhersteller, vfa), such as repeated scientific consultation, early acceptance of data packages relevant for the authorisation or approval by the drug authorities and their continuous processing (rolling review).
"Especially in times of the SARS-CoV-2 pandemic, this exchange is an important contribution to the urgently needed medical progress,"
highlighted Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut. Representatives from the vfa emphasised the good complementary cooperation in the development of vaccines and biomedicines against COVID-19. By the end of August, the Paul-Ehrlich-Institut had processed 78 scientific consultations and 27 approvals for clinical trials. The association and the participating company representatives highly appreciated the possibility of binational scientific consultations offered jointly by regulatory authorities from two countries each, and gave advice on further optimisation. The Paul-Ehrlich-Institut has already successfully conducted 14 of such binational consultations.
Further topics included ensuring the supply vaccines and biomedicines. The cooperation of the companies with the Paul-Ehrlich-Institut in importing additional vaccine doses in case of a supply shortage and the supply planning with seasonal influenza vaccines was evaluated positively by the participants. This had ensured the supply of around 26 million doses of influenza vaccines for the 2020/21 flu season - significantly more than last year and should make it possible to meet higher demand, which is expected.
The increasing digitalisation of processes and information was also on the agenda: Companies now submit up to 80 percent of all applications for approval of clinical trials electronically, and scientific consultations take place in virtual space. The association presented planned electronic information services for discussion. Digital future projects such as an app, with which citizens can download the latest directions for use for medications, and the electronic transmission of Red-Hand letters have also been discussed at the political level for some time and would be well suited to demonstrate the benefits of digitisation in the healthcare sector. But they would also fit in well with digitisation initiatives at a national and a European level.
Updated: 23.09.2020
