COVID-19 vaccines: progress and understanding on quality control and evaluation

Abstract

The outbreak of COVID-19 has posed a huge threat to global health and economy. Countermeasures have revolutionized norms for working, socializing, learning, and travel. Importantly, vaccines have been considered as most effective tools to combat with COVID-19. As of the beginning of 2021, >200 COVID-19 vaccine candidates, covering nearly all existing technologies and platforms, are being research and development (R&D) by multiple manufacturers worldwide. This has posed a huge obstacle to the quality control and evaluation of those candidate vaccines, especially in China, where five vaccine platforms are deployed in parallel. To accelerate the R&D progress of COVID-19 vaccines, the guidances on R&D of COVID-19 vaccine have been issued by National Regulatory Authorities or organizations worldwide. The Center for Drug Evaluation and national quality control laboratory in China have played a leading role in launching the research on quality control and evaluation in collaboration with relevant laboratories involved in the vaccine R&D, which greatly supported the progression of vaccines R&D, and accelerated the approval for emergency use and conditional marketing of currently vaccine candidates. In this paper, the progress and experience gained in quality control and evaluation of COVID-19 vaccines developed in China are summarized, which might provide references for the R&D of current and next generation of COVID-19 vaccines worldwide.

Establishment of the first Chinese national standard for protein subunit SARS-CoV-2 vaccine

“…Reference materials are required to ensure the safety, effectiveness, and consistency of vaccines. The use of reliable, stable, and uniform standard materials is necessary to ascertain whether the internal and external regulatory QC requirements are met [10] . Hou et al .…”

“…In the suitability study, CS exhibited excellent parallelism and a linear relationship with the four samples. In a previous study [10] , the raw material was distributed to 11 different laboratories to investigate more extensive suitability. The CS showed good parallelism and linearity with either S protein expressed in CHO cells and Pichia pastoris , or RBD protein expressed in CHO cells, Pichia pastoris, E. coli , and Sf9 cells.…”

“…Enzyme-linked immunosorbent assay (ELISA) is a well-accepted method for quantifying antigen content. The NIFDC extensively screened monoclonal antibody libraries to obtain antibodies suitable for establishing a double antibody sandwich ELISA-based kit as a feasible method for antigen detection, which showed good suitability in vaccines developed from different expression systems and target proteins [10] . We designated this established antigen detection method as the “common kit”.…”

Review on Drug Regulatory Science Promoting COVID-19 Vaccine Development in China

“…China relied on national vaccine quality control laboratories, related inspections, and scientific research institutions to study and develop relevant animal models [32] , [33] , [34] , [35] , [36] , [37] , quality control methods [38] , reference materials [39] , and quality specifications for innovative vaccine R&D for COVID-19 immediately after the outbreak [40] . Through laboratory work, such as virus seed verification, cell bank verification, product verification, and clinical serum testing, Chinese researchers have ensured the safety and effectiveness and promoted the R&D of COVID-19 vaccines.…”

Herpetic Keratitis Preceded by COVID-19 Vaccination

“…Vaccination is an effective approach to alleviate the current pandemic [1]. Globally there are twelve COVID-19 vaccine candidates approved for use, and many more are under clinical or pre-clinical development process [2]. Results from large clinical trials have proved the protection effect of vaccines against COVID-19 infection and transmission [3,4].…”