U.S. Food and Drug Administration (FDA)/Office of Vaccines Research and Review (OVRR), Maryland, USA
What are you and your institution currently working on regarding COVID-19?
The U.S. FDA Center for Biologics Evaluation and Research (CBER) investigators have established hamster models of SARS-CoV-2 infection and are currently working on evaluation of protective immunity and therapeutic interventions vis-a-vis COVID-19. Surrogate tests for rapid analysis of antibodies against the coronavirus were recently established and detailed. Elaborate characterization of antibody response to SARS-CoV-2 infection is also underway along with investigation into the role of various cytokines in the pathogenesis of COVID-19. Further, different viral vector platforms for delivery of S-protein are under evaluation at this time.
Please describe in detail your work on the Oral Polio Vaccine (OPV) SARS-CoV-2 vaccine based upon the R-Strategy vulnerable populations.
We work on creation of new approaches and methods for evaluation of safety and efficacy of viral vaccines, with specific focus on live and inactivated poliovirus vaccines. Our lab pioneered introducing molecular methods based on quantitative polymerase chain reaction (PCR) and next-generation sequencing for monitoring consistency of vaccine manufacturing. This is a part of the global efforts to reduce, refine, and replace animal testing. It also included the development of transgenic mouse models to test for residual neurovirulence of attenuated polio vaccine, as well as improved potency assays for inactivated polio vaccine based on human monoclonal antibodies. Methods developed in this lab were recommended by the WHO for routine quality control of poliovirus vaccines. We are also working on improved bioinformatic pipelines for in-depth analysis of deep-sequencing data for characterization of viral quasispecies and metagenomic surveillance. As part of the international consortium assembled by the Bill and Melinda Gates Foundation, this lab is participating in the development of a next-generation genetically stable Oral Poliovirus Vaccine. Since the beginning of SARS-CoV-2 pandemic, we have been collaborating with Dr. Robert Gallo and his team on promoting novel disease prevention strategies based on non-specific protective effects induced by live viral vaccines.
Dr. Konstantin Chumakov serves as the Associate Director for Research at the FDA Office of Vaccines Research and Review. He is also an Adjunct Professor at the George Washington University and the University of Maryland, and a Director of the Global Virus Network Center of Excellence at the FDA. He is an advisor to the World Health Organization and a member of the WHO Polio Research Committee.
Dr. Chumakov earned his PhD degree in virology from the Moscow State University in 1973 as well as a Doctor of Sciences in molecular biology in 1987. Between 1973 –1887 he was a Research Scientist at the Laboratory of Molecular Biology and Bioorganic Chemistry at the Moscow State University. From 1987 to 1989 he was Chief of the Laboratory of Bacterial Genetics at the Institute of Microbiology of the Soviet Academy of Sciences in Moscow. In 1989 he moved to the US FDA Center for Biologics Evaluation and Research where he is a Principal Investigator and Laboratory Chief in the Division of Viral Products.
His scientific interests are in poliovirus biology, bioinformatics, and creation of molecular methods for evaluation and quality control of vaccines and other biological products.
About the FDA/OVRR
The U.S. FDA Center for Biologics Evaluation and Research (CBER) is the world’s oldest institution responsible for regulation of biologically-derived medical products. As its name suggests, a vital mission of CBER is to conduct regulatory research to better understand basic and translational aspects of regulated products, and to inform development, evaluation, and manufacture of various biologicals. The Office of Vaccines Research and Review (OVRR) is one of the three product offices, along with the Office of Blood Research and Review, and the Office of Tissue and Advanced Therapies that also regulates gene and cellular therapies. In addition to their regulatory responsibilities, CBER staff is actively engaged in intramural research programs that address unresolved scientific issues underlying regulatory decisions, create methods and reference standards, and explore emerging strategies for novel biological products. The area of regulatory and research purview of OVRR includes vaccines against viral, bacterial, and parasitic diseases, allergenic products for both diagnostic and therapeutic use, as well as live bio-therapeutic products, such as probiotics, fecal microbiota transplantation, and phage therapy. The Office’s research portfolio includes 35 independent research programs covering a wide range of viral and bacterial pathogens.