Aspects and issues of marketing authorisation and use of medicinal products for COVID-19 prevention during the pandemic

At the end of 2019, an outbreak a new coronavirus began in city Wuhan (Hubei Province) People's Republic China. The turned into pandemic. In shortest possible time, national and international manufacturers developed preventive COVID-19 vaccines, population was vaccinated. During pandemics, accelerated approval vaccines is important factor that shortens time to market with aim mass vaccination. experience rapidly developing introducing routine practice not only for managing current pandemic, but also valuable case extremely likely future ones. this study analyse main issues associated assessing safety efficacy prevention during their registration widespread use amid pandemic ongoing SARS-CoV-2 evolution. were introduced healthcare very under circumstances these has surfaced number concerns requiring further research. most identified performed analysis include, are limited need assessment immunogenicity vaccines; lack immune correlates protection against SARS-CoV-2; waning antibody immunity over motivating determine revaccination post-recovery vaccination timelines; emergence mutant variants. One noteworthy aspects develop recommendations updating strain composition registered vaccines. According conclusions, level herd immunity, including vaccine-induced protection, plays certain role virus evolution If becomes seasonal, which probable scenario, regular can be essential.