If necessary, the Paul-Ehrlich-Institut requests further information and cumulative evaluations in order to check whether the report could have changed the benefit and risk of the study or whether additional risk-minimizing measures, such as dose reduction or additional diagnostics, need to be implemented in order to ensure the safety of the study participants. and toxicology as well as immunogenicity. For COVID-19 vaccine candidates, based on existing platform technologies with a sufficiently broad data base, pharmacologicalCtoxicological testing in the case of repeated administration, quantifying systemic distribution, and proof of vaccination safety in animal models can be carried out in parallel to phase 1 or 1/2 medical trials. To reduce the theoretical risk of an increased respiratory illness through infection-enhancing antibodies or as a result of Th2 polarization and modified cytokine profiles of the immune response HOXA11 following vaccination, which are of specific concern for COVID-19 vaccines, appropriate investigative testing is definitely imperative. In general, phase 1 (vaccine security) and 2 (dose finding, vaccination routine) clinical tests can be combined, and combined phase 2/3 tests are recommended to determine security and effectiveness. By applying these fundamental requirements not only for the authorization and analysis of clinical tests but also for the regulatory evaluation during the assessment of marketing authorization applications, several efficacious and safe COVID-19 vaccines have been licensed in the EU by unprecedentedly fast and flexible methods. Procedural and regulatoryCscientific aspects of the COVID-19 licensing processes are described with this review. strong class=”kwd-title” Keywords: SARS-CoV-2, vaccine development, clinical trials, marketing authorization 1. Intro SARS-CoV-2 has been described in late 2019 as the GW3965 pathogen associated with a new syndrome in Wuhan, China, which is now termed SARS-CoV-2-related coronavirus GW3965 disease (COVID-19). The disease offers consequently spread globally due to high transmissibility between humans, with far-reaching effects. The pandemic offers led to excessive overburdening of many healthcare systems globally, GW3965 including high numbers of hospitalizations and deaths . Worldwide, more air flow mattresses than those available were often required for the rigorous care treatment of individuals severely ill with COVID-19. During the maximum time of the pandemic, the number of COVID-19-related deaths continued to rapidly increase, and still today instances of infections, diseases, and deaths are perpetually recognized. Public health countermeasures, including full lockdowns, aim to reduce infection rates; however, these measures are having huge negative effects on social activities and the economies of the affected countries. Novel vaccines have developed as valuable tools to protect against COVID-19. Vaccines offer the most effective remedy to resolve the current pandemic due to (i) the prevention of virus-induced COVID-19 (or at least of severe instances) and (ii) the reduction of human-to-human transmission rates. According to the WHO, over 270 vaccine projects have been started worldwide, with almost 100 clinical tests of specific COVID-19 vaccines initiated until the first quarter of 2021 . This extremely high number of product developments reflects the urgent need for different COVID-19 vaccines, the high production capacity of doses necessary for global use, as well as the medical urgency and the need to return to a normal life without contact restrictions. A multitude of founded GW3965 and experimental vaccine platforms have been developed for COVID-19 prevention, including platforms based on genetic information such as DNA, RNA, and vector vaccines, as well as subunit vaccines based on genetically manufactured protein antigens, peptide vaccines, and even adjuvanted inactivated whole disease vaccines . Due to the urgent need, vaccine development has been given the highest priority not only by political decision-makers but also from the academia, pharmaceutical market, and medicines regulatory agencies. However, despite this urgent need, it is of important GW3965 importance to ensure the necessary care and scrutiny in rules and product evaluation. Worldwide, agreements have been made between the globally active medicines regulatory agencies within the criteria for the authorization of clinical tests. Creating.