COVID-19 Vaccine Candidates – International Harmonisation of the Requirements for the first Clinical Trial

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, in co-operation with international vaccine experts of medicines authorities who act at a world-wide level discussed the fundamental requirements for first clinical trials of COVID-19 vaccine candidates in a workshop in March.

"The world-wide harmonisation of the regulatory requirements and discussions regarding this between the competent medicines authorities in the EU and the European Economic Area (EEA) responsible for authorising clinical trials pave the way for accelerating the development of a COVID-19 vaccine", as Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut, emphasised.

Experts of the international medicines authorities agree that three aspects are essential in the decision on an authorisation of a clinical trial:

• Preclinical data on the dosing and immunogenicity of a vaccine candidate and on the toxicity of repeated administrations are indispensable prerequisites for a phase-1 clinical trial in humans (first-in-man).
• The theoretical risk that a vaccine against COVID-19 could aggravate the disease must be addressed and assessed by the vaccine developers before the phase-1 clinical trial.
• Depending on the vaccine – after a careful risk/benefit assessment – data already available for similar vaccines ("vaccine platforms") can be used in the trials.

Against the background of the world-wide spreading of the SARS-CoV-2 pathogen, the public demands a rapid development of a vaccine. In order for a vaccine candidate against COVID-19 to qualify for a clinical trial, a data basis with high informational value still required, together with a scientific analysis of this database with regard to efficacy and safety of the respective product. Harmonised regulatory requirements for clinical trials are an important step for medicines developers suitable to accelerate the processes of vaccine development against COVID-19.

The discussion took place in the setting of a virtual workshop organised by the International Coalition of Medicines Regulatory Authorities (ICMRA).

About the Workshop

The regulatory workshop took place on 18 March 2020 during the continued COVID-19 pandemic. The workshop was attended by participants from 17 different countries representing more than 20 regulatory authorities world-wide, as well as experts from the World Health Organization (WHO), the European Commission, the Food and Drug Administration (FDA), who exchanged their views on vaccines against COVID-19.