Regulatory aspects and methodological considerations in the clinical evaluation of vaccines

Regulatory aspects and methodological considerations in the clinical evaluation of vaccines

Oral presentation

Zornitsa Zaharieva, Emil Hristov
Faculty of Chemistry and Pharmacy, Sofia University "Saint Kliment Ohridski", Bulgaria

Vaccines are immunological medicinal product, used to produce active or passive immunity or to establish a state of immunity. During the pre-registration phase, immunogenicity trials have a key role in defining the type and quantity of the immune response which predicts their clinical efficacy. The efficacy is defined by prospective randomized double-blind trials usually through comparing the reduction of the frequency of the given infectious disease after the vaccination with comparison of the frequency under non-vaccination. The main considerations for the assessment of safety are the same as the other drugs with focus-ADRs .The aim of research is to analyze the applicable regulatory aspects and methodically considerations at clinical assessment of vaccines in the context of the pandemic from COVID-19. Materials and methods. We conducted content analysis and documentary analysis on published manuals from EMA, WHO and ICH regarding the evaluation of the clinical effectiveness of vaccines, toxins, and serums for the period of 2005 until now. Results and Discussion. The development of standard vaccine is a long process with duration around 8-10 years while the vaccines against COVID-19 were developed for much shorter period 1-2 years, through combining the clinical trial phases or parallel conduction of some studies etc. Although the short time frame they are developed according to GLP, GCP, GMP, evaluated and approved through current scientific knowledge and applicable regulatory standards of EU and ICH. Their quality, safety and efficacy are unquestionably established but over time the data for their effectiveness suffered different metamorphoses – duration of protection, immunogenicity, strength of the immune response.
Keywords: Vaccines, safety, efficacy, effectiveness, COVID-19