Fighting the Pandemic with Vaccines, Biomedicines and High-Performance IVDs |

The Paul-Ehrlich-Institut has been able to provide regulatory and experimental research support to help fight the pandemic. Our activity focus included (i) scientific advice on COVID-19 vaccine development and clinical trial authorization, benefit-risk assessment in the CHMP at the European Medicines Agency and governmental batch release testing, (ii) national authorization of neutralizing monoclonal antibodies for the treatment of infected persons at risk of severe COVID-19 disease course, (iii) experimental investigation of SARS-CoV-2 rapid antigen test performance and (iv) pharmacovigilance incldg. reports to the public.

The COVID-19 pandemic has brought to light several lessons learned from vaccine and biomedicine development. One key factor has been the unexpectedly high efficacy of the COVID-19 vaccines, which is generally attributed to effective antigen design. Higher efficacy of COVID-19 vaccines has been linked to higher serum titers of CoV-2 neutralizing antibodies, as for example demonstrated by the 4th Wuhan mRNA vaccination (2nd booster), which increases anti-Omicron antibody titers to the level detected early after the 3rd mRNA vaccination (1st booster).

In response to the pandemic, there has been a push for greater regulatory flexibility to rapidly adapt drug legislation and support the development of vaccines and biomedicines. Neutralizing antibodies were thus made available for treatment of infected persons at risk of severe COVID-19 by national authorization. Comparative experimental evaluations of the sensitivity of marketed SARS-CoV-2 rapid antigen tests have been conducted by the Paul-Ehrlich-Institut to enhance pandemic preparedness. Periodical Safety Reports on COVID-19 vaccine pharmacovigilance were made available to the public and helped to enhance vaccine confidence and rational discussions about vaccine safety. The newly inaugurated Center for Pandemic Vaccines and Therapeutics (ZEPAI) at the Paul-Ehrlich-Institut (PEI), with its vision and mission to provide expertise in pandemic preparedness regarding pandemic vaccines and antivirals, will support pandemic preparedness on the basis of lessons learned from the SARS-CoV-2 pandemic. Research activities at PEI include non-clinical research on model vaccines and vaccine-induced immune responses. The regulatory support provided by PEI to vaccine and biomedicine developers has been instrumental in the successful response to the pandemic.