DC Discussion Group

Progress and Current Challenges for mRNA Flu Vaccines | Rockville, MD, USA | June 26, 2024 15:00 - 17:00 EST

Join us in person at the IBBR campus where you can network with DC-area CASSS members. The June Discussion Group will be fully in-person. More information coming soon. Registration closed June 25, 2024.

Location:
Institute for Bioscience and Biotechnology Research
9600 Gudelsky Dr.
Rockville, MD, USA 20850

Influenza Virus mRNA Vaccines: How should CMC and Regulatory Strategies Adapt to an Evolving Virus?

Influenza virus, the archetypical member of the Orthomyxoviridae family, infects approximately 8 percent of the U.S. population per year, resulting in 4,900 to 51,000 deaths, 100,000 to 710,000 hospitalizations, and more than $3 billion in lost economic output annually from seasonal outbreaks. Moreover, the possibility of highly lethal pandemic outbreaks from avian or other animal reservoirs, such as the 1918 Spanish Influenza outbreak, is an ever-present threat to human health.

Since 1945, an influenza vaccine produced from chicken eggs has been available to protect against seasonal Influenza; starting in 2013 egg-free recombinant vaccines were made publicly available in the US. A major challenge to Influenza vaccination is the need for a new vaccine annually; the Influenza virus sequence undergoes rapid changes due to antigenic drift (accumulated mutations) and antigenic shift (mixing of gene segments between different Influenza virus strains in a single host). This challenge has created a pressing need for vaccine manufacturers to adopt new approaches to swiftly design Influenza virus vaccines against rapidly emerging virus strains.

Recently, the use of mRNA as a vaccine platform against rapidly evolving SARS-CoV2 strains has opened up a new modality for Influenza vaccination. This DCDG session will focus on CMC strategies that ensure the safety, quality, and efficacy of traditional Influenza vaccines, and how those strategies may be adapted or altered to be fit for purpose to assess the potential next-generation mRNA-based Influenza vaccines.

*Influenza Burden Figures from CDC and WHO Influenza websites

Featured Speaker:
Masaru Kanekiyo, National Institute of Allergy and Infectious Diseases (NIAID)

Featured Panelists:
Matthew Brecher, GlaxoSmithKline
Robin Levis, CBER, FDA

Speaker | Masaru Kanekiyo, National Institute of Allergy and Infectious Diseases (NIAID)

Dr. Masaru Kanekiyo obtained his DVM in 2002 and PhD in 2006. Kanekiyo did his postdoctoral training at the Vaccine Research Center (VRC) with Dr. Gary Nabel studying protein engineering and nanoparticle-based vaccine design. In 2014, Kanekiyo joined the laboratory of Dr. Barney Graham at the VRC as a Staff Scientist and was later appointed head of the Molecular Immunoengineering Unit. In 2022, Kanekiyo was named Chief of the Molecular Immunoengineering Section (MIS) at the VRC. Kanekiyo is also an Earl Stadtman Tenure-Track Investigator. Kanekiyo focuses his efforts on understanding the vaccine-host interface to define immunological principles that inform the design of effective vaccines against highly challenging targets, such as influenza virus. His interests include vaccine design, protein engineering, self-assembling nanoparticles, immunofocusing and immunotargeting, vaccine-elicited and infection-induced immunity, antibody discovery, animal models, and virus-host co-evolution.

Panelist | Matthew Brecher, GlaxoSmithKline

Matthew Brecher is an expert scientist in analytical R&D at GlaxoSmithKline. His experience includes doctoral research exploring viral glycoproteins and virus-cell entry, postdoctoral research developing screens for inhibitors of proteins essential to Flavivirus (e.g. Dengue and Zika) replication, and postdoctoral work exploring the fitness of a potential Dengue vaccine backbone in Aedes mosquitos. He has also contributed to the Cryo-EM Structure of Influenza Virus, and to the development of GSK’s RSV Vaccine AREXVY.   

Panelist | Robin Levis, CBER, FDA

Robin Levis has worked at the US Food and Drug Administration since 1995. She is currently the Deputy Director of the Division of Viral Products in the Office of Vaccines Research and Review at CBER/FDA; a position she has held since 2006. As Deputy Director, Dr. Levis has review oversight for all regulatory activity in the Division. In addition, she works on global policy efforts for regulatory convergence and on the reduction of animal use in product development and testing. Prior to this position, she served as the Regulatory Coordinator for the Division of Viral Products (2002-2006) and served as a Senior Staff Fellow in the Laboratory of Vector Borne Viral Diseases (1995-2002). Her initial research work at the FDA related to dengue virus replication. She then transitioned to being the lead CMC reviewer for licensed rabies virus vaccine products and rabies vaccine and related products under development. In addition to her work on rabies, Levis served as the primary CMC reviewer for the Human Papillomavirus (HPV) vaccines to prevent cervical and related cancers. Levis continues to be involved in the review and regulation of all viral vaccines.