Essential work in Times of Pandemic
The development and marketing authorisation of vaccines and biomedicines in times of pandemic requires commitment, expertise and experience – and the courage to adopt new approaches.
Vaccines are and will remain the most effective method of containing the SARS-CoV-2 pandemic – and of protecting oneself and others from COVID-19. All over the world, those involved in vaccine development are working closely together to accelerate processes, without compromising on due care and diligence. Experience shows that the development of a vaccine takes more than ten years – but this time it had to be faster. Various factors made this possible:
- A known potentially protective antigen from previous work on SARS-CoV-1 and MERS-CoV vaccines
- New vaccine technologies such as mRNA and vector vaccines
- Intensive scientific advice
- Selected non-clinical studies carried out in parallel with clinical trials
- Overlapping phase 1/2 and 2/3 trials
- Rolling review of marketing authorisation documents
- Manufacture even before marketing authorisation
- High degree of focus and generous financial support
- Worldwide cooperation
In addition to the prophylactic vaccines, treatment options are required for people suffering from COVID-19. Scientists tried out authorised medicinal products against the new virus in order, if successful, to expand their indication. Another option was convalescent plasma: neutralising antibodies from the plasma of people who have recovered from COVID-19 should support the immune system of COVID-19 patients. There was also a focus on genetically engineered monoclonal antibodies, either to interrupt infection pathways in a targeted manner or to regulate an excessive immune response to SARS-CoV-2.
The Paul-Ehrlich-Institut supported the development of COVID-19 vaccine products and biomedical therapies right from the start, both scientifically and from a regulatory perspective. The focus was always on the quality, efficacy and safety of the medicinal products. In this respect, it was a question of maintaining a balance between rapid availability and proven efficacy, of responding in an appropriate manner to the urgent demands of the media, the political world and the general public, of promoting new development approaches as far as possible and of guaranteeing scientifically sound procedures.
The Paul-Ehrlich-Institut and its staff faced the challenges of the SARS-CoV-2 pandemic with great commitment, flexibility and perseverance.
Working from home, travel restrictions and social distancing rules required a major rethink in how work was organised, in favour of new structures such as shift work, digitised processes and virtual meetings. This allowed the Paul-Ehrlich-Institut to perform its official duties successfully and to make an essential contribution to fighting the pandemic.