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  1. Science & Research (Biologics)

Supporting the Production of Safe and Effective Influenza Vaccines


Zhiping Ye Headshot

Zhiping Ye, M.D., Ph.D.

Office of Vaccines Research and Review
Division of Viral Products
Laboratory of Pediatric and Respiratory Viral Disease



Dr. Zhiping Ye received a Ph.D. degree in Virology from Department of Microbiology, University of Virginia, School of Medicine, Virginia, US and a M.D. degree in Medicine from Shanghai First Medical University, Shanghai, China. In 1980s, he worked in Dr. Chi-Ming Chu’s laboratory in the Institute of Virology, Beijing, China, where he involved in studying epidemiology of influenza virus and development of influenza vaccines. In Dr. Robert Wagner’s laboratory in University of Virginia, he worked extensively with influenza virus and vesicular stomatitis virus.

Dr. Zhiping Ye serves as Chief of Laboratory of Pediatric and Respiratory Vial Diseases in Center for Biologics and Evaluation and Research, Food and Drug Administration (FDA). Dr. Ye has spent over twenty years working on the replication and pathogenesis of influenza viruses. His studies are recognized in the fields of influenza virus as well as influenza vaccines. He is also involved in regulatory work, such as reviewing Investigational New Drug applications and Biological Licensing Applications relating to influenza vaccines for the United States. As a temporary adviser for World Health Organization Global Influenza Program from FDA since 2001, he participates in WHO bi-annual consultation on selection of vaccine viruses for updating the composition of influenza vaccines for Northern and Southern hemispheres.

General Overview

Each year, about 38,000 people in the United States die from influenza infections. In addition, pandemic influenza (worldwide outbreaks) pose a global threat to public health. One of the most effective strategies for preventing seasonal and pandemic influenza infections is vaccination. The need for new vaccines was made more urgent by the emergence of strains of influenza virus that have the pandemic potential, as in the case of the pandemic 2009 H1N1 (swine flu) virus. Production of vaccines against pandemic viruses is slowed by the difficulty in manufacturing of these products, requiring innovative approaches.

Influenza vaccines are designed to trigger immune responses against critical surface proteins called hemagglutinin (HA) and neuraminidase (NA). However, new variants of influenza viruses carrying modified types of HA and NA appear each season. Since existing influenza vaccines would not be able to trigger effective immune responses to these new variants, modified vaccines must be made to protect against an influenza outbreak caused by new variant viruses.

The majority of vaccines used to control annual influenza epidemics in the United States are manufactured using embryonated chicken eggs that are infected with live influenza viruses. These viruses are harvested, inactivated, and used to make vaccines. Most wild-type viruses (i.e., the form that appears in nature) that carry the right HA and NA proteins to make vaccines do not grow in large enough quantities in eggs to support vaccine production. To solve these problems, we modify influenza virus genes in order to produce viruses that grow in large enough quantities to make vaccines and to carry the exact version of HA and NA proteins of that season's influenza virus. In addition, we modify the viruses so they cannot cause disease, reducing the risk to laboratory workers.

We are concentrating our work in these areas on both licensed inactivated influenza virus vaccines and new influenza vaccines that are under clinical development. This research uses state-of-the-art molecular biology techniques to 1) improve production and safe handling during production of pandemic influenza vaccines; and 2) facilitate development of new vaccines for both seasonal and pandemic influenza virus by optimizing the production of vaccine proteins by viral genes. Overall, our research directly impacts the safety, effectiveness, and availability of both seasonal and pandemic influenza vaccines.

Scientific Overview

Our research program addresses several critical and unmet research needs of the influenza vaccine program in the U.S. There are three types of licensed influenza vaccines in U.S.: inactivated, live attenuated, and recombinant vaccines. Currently the inactivated influenza viruses are the major sources for immunization of general population against influenza virus infection in the U.S. Each year manufacturers and federal agencies struggle to identify influenza viruses to be used as vaccine strains, i.e., circulating viruses with appropriate antigenic characteristics and growth properties sufficient to support production of over 150 million inactivated seasonal influenza vaccine doses.

Most wild-type viruses with appropriate antigenic characteristics do not grow to sufficiently high titer in eggs or cells to support vaccine production, and high growth laboratory strains do not contain the appropriate antigenic properties in surface proteins (e.g., HA, NA) of the current year’s circulating wild type strains. Thus, genetic mixtures of the wild type and laboratory strains termed high growth reassortants, are created to contain the growth and immunogenic properties necessary for efficient preparation of commercial quantities of effective new inactivated influenza virus vaccines each year. Understanding how influenza virus proteins control replication is crucial in generating high growth viruses by modifying virus genes.

Although multiple genes of influenza viruses contribute to viral replication and attenuation/virulence properties, we continue to investigate the roles of matrix (M) and NA genes of influenza A virus in viral replication, attenuation, and virulence in vitro and in vivo. Our laboratory focuses particularly on the matrix 1 (M1) protein of influenza A virus and genetic manipulation of the matrix gene of influenza A virus.

Our research program also addresses several critical research needs of the influenza vaccine program by using techniques such as reverse genetics to identify and analyze the functional domains of influenza virus protein(s). Based on our work in this area, we can now modify viruses such as virulent wild-type avian influenza virus to be less pathogenic, or to endow a low-yield virus with high-growth capabilities suitable for preparation of inactivated influenza vaccines.

Important Links


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