Influenza 2013: Epidemiology, Vaccines and Threats

Influenza 2013: Epidemiology, Vaccines and Threats

Thursday, November 14, 2013

The New York Academy of Sciences

Influenza continues to confound us with the continual evolution of the virus and emergence of new influenza viruses from the animal reservoir. In 2013, H7N9 has emerged from the avian reservoir in China killing 40 people in China with concern for further spread; H1N1pdm emerged four years ago to cause a pandemic and continues to circulate causing disease; concern continues over the virulent H5N1 and possible entry into the general population. The annual seasonal vaccines have been improved to broaden response with quadrivalent vaccines; low immunogenicity has been addressed with increased antigen content in vaccines. Many new developments have been made in live flu vaccines, and a new vaccine containing only the main surface antigen has been approved by the FDA. Looking ahead, a synthetic approach to improve the vaccine will be discussed. Join us in anticipation of the upcoming flu season to explore emerging threats and strategies for protection.

*Reception to follow.

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Agenda

* Presentation titles and times are subject to change.


November 14, 2013

11:30 AM

Registration

12:00 PM

Welcome and Opening Remarks
Doris Bucher, PhD, New York Medical College
Jennifer Henry, PhD, The New York Academy of Sciences

12:15 PM

Keynote Presentation: Influenza: Epidemiology, Molecular Aspects and Vaccine Effectiveness
Nancy J. Cox, PhD, Centers for Disease Control and Prevention

1:00 PM

Pandemic Influenza Risk Assessment and Vaccine Development
Ruben Donis, DVM, PhD, Centers for Disease Control and Prevention

1:30 PM

Individualized Influenza Vaccines: Quadrivalent, Intradermal and High-Dose
David P. Greenberg, MD, Sanofi Pasteur US

2:00 PM

Coffee Break

2:30 PM

Live Attenuated Influenza Vaccine: 2013 Update
Kathy Coelingh, PhD, MedImmune

3:00 PM

Flublok®: The First Recombinant Influenza Vaccine Approved by the FDA
Manon M. J. Cox, PhD, MBA, Protein Sciences

3:30 PM

Improving Influenza Immunization with Synthetic Vaccine Viruses
Philip R. Dormitzer, MD, PhD, Novartis Vaccines and Diagnostics

4:00 PM

Closing remarks
Allan R. Goldberg, PhD, Avacyn Pharmaceuticals, Inc.

Networking Reception

5:00 PM

Close

Speakers

Organizers

Doris Bucher, PhD

New York Medical College

Dr. Doris Bucher is an Associate Professor in the Dept. of Microbiology and Immunology at New York Medical College, Valhalla, NY.  Dr. Bucher has dedicated most of her research career to work on influenza viruses and influenza vaccine development.

Her laboratory group at New York Medical College (NYMC) is one of three laboratories worldwide which produce high growth reassortant ‘seed’ viruses for the influenza vaccine.  For the past ten years one to three NYMC reassortants have been used for the bulk of world flu vaccine (inactivated) production of 500 million doses.  For the 2013-2014 vaccine, several manufacturers used NYMC reassortants for all three components of the trivalent vaccine or all four components of the quadrivalent vaccine.

Shortly after identification of 2009 H1N1pdm (swine influenza) by the CDC in April 2009 her laboratory was provided with the 2009 H1N1pdm isolate.   A reassortant ‘seed’ virus, NYMC X-179A, was developed for the vaccine in about three weeks.  X-179A, was used worldwide by manufacturers to produce the 2009 H1N1pdm vaccine (inactivated, egg based).  Several weeks later her laboratory produced two second generation reassortants, NYMC X-181 and X-181A, with even better growth properties; several flu manufacturers continued production of swine flu vaccine with these reassortants.  X-179A and X-181 continue to be used in the seasonal trivalent (or quadrivalent) vaccine as the H1N1 component.

All available candidate vaccine viruses including our NYMC seeds are listed at the WHO website: http://www.who.int/influenza/vaccines/virus/en/.

The Bucher lab is supported by the influenza vaccine manufacturers through their organization, IFPMA (International Federation of Pharmaceutical Manufacturers and Associations), Influenza Vaccine Supply Task Force, based in Geneva.

Allan R. Goldberg, PhD

Avacyn Pharmaceuticals, Inc.

Dr. Goldberg is currently the President and CEO of Avacyn Pharmaceuticals, Inc., a company that is developing a next generation of anti-bacterial drugs characterized by their inability to induce detectable drug resistance.  The Company’s lead drug candidate was developed at Astex Pharmaceuticals, Inc. through a research collaboration which he conceived and initiated with The Rockefeller University.   He is Partner Emeritus and co-founder of The Channel Group, and has been instrumental in the formation and development of a number of start-up life science companies. In addition, he co-founded previously a venture management partnership called PrimeTech Partners that created, financed, and developed several companies engaged in biomedicine.  Through PrimeTech Dr. Goldberg was a scientific and business co-founder and director of ZyStor Therapeutics, Inc., a Milwaukee-based biotechnology company that developed a protein manufacturing and delivery platform technology for the treatment of various lysosomal storage diseases, including an enzyme-based protein therapeutic for Pompe disease that is currently entering a Phase II/III clinical trial.  BioMarin Pharmaceutical Inc. (NasdaqNM: BMRND) acquired ZyStor in August, 2010.  Prior to founding PrimeTech Partners, Dr. Goldberg was founder of Innovir Laboratories, Inc., a public biotechnology company that engaged in developing technologies based on harnessing the natural ribozyme RNase P for pharmaceutical and genomic research and the treatment and prevention of disease.  Dr. Goldberg was a professor of virology and the Richard King Mellon Foundation Fellow at The Rockefeller University prior to founding Innovir.  Dr. Goldberg has been a consultant to several pharmaceutical companies and to several private and public academic institutions.  He was on the Board of Directors of Astex Pharmaceuticals, Inc.(NasdaqGM: ASTX), a pharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics for solid tumors and hematological malignancies.  Astex was sold to Otsuka Pharmaceuticals in October 2013.  Dr. Goldberg earned a B.A. from Cornell University and a Ph.D. from Princeton University, and was a postdoctoral fellow at Albert Einstein College of Medicine.

Jennifer Henry, PhD

The New York Academy of Sciences

Keynote Speaker

Nancy J. Cox, PhD

Centers for Disease Control and Prevention

Nancy J. Cox, PhD, is Director of the Influenza Division at the Centers for Disease Control and Prevention (CDC) and Director of CDC’s World Health Organization (WHO) Collaborating Center for Surveillance, Epidemiology and Control of Influenza. She received a bachelor’s degree in bacteriology from Iowa State University in 1970. Dr. Cox was awarded a Marshall Scholarship to study in England at the University of Cambridge where in 1975 she earned a doctoral degree in virology. Dr. Cox began her career as a postdoctoral fellow, first at the University of Maryland, Baltimore County and subsequently at the Centers for Disease Control and Prevention. She was selected as the Chief of the Molecular Genetics Section of the Influenza Branch in 1983, Chief of the Influenza Branch in 1992 and as Director of the Influenza Division in 2006. She serves frequently as a WHO temporary advisor for influenza vaccine virus selection and has worked with WHO to expand and improve WHO’s Global Influenza Surveillance and Response System. In her capacity as Director of CDC’s WHO Collaborating Center for Influenza, she has organized and participated in numerous WHO activities and national and international training courses on influenza epidemiology, surveillance, virus isolation and virus characterization. Dr. Cox is the recipient of numerous scientific and achievement awards, including CDC’s Charles C. Shepard Science Awards in 2001, 2005, 2007, 2008 and 2009. She was recognized by Time magazine as one of the “Time 100: The People Who Shape our World” and by Newsweek magazine for the “Giving Back Awards” in 2006.  In addition, Dr. Cox was awarded the Service to America Medals Federal Employee of the Year for 2006.  She is the author and co-author of over 250 research articles, reviews and book chapters.

Speakers

Kathy Coelingh, PhD

MedImmune

Kathleen L. Coelingh, PhD is Senior Director, Medical and Scientific Affairs at MedImmune, the biologics unit of AstraZeneca.  She has authored 70 research papers in peer-reviewed journals, and is responsible for strategic health policy regarding MedImmune’s nasal influenza vaccine.

Prior to joining MedImmune, Dr. Coelingh was a senior staff fellow in the Laboratory of Infectious Diseases for ten years at the US National Institutes of Health (NIH).  While at the NIH she led the team that discovered the mouse monoclonal antibody that neutralizes Respiratory Syncytial Virus (RSV), which was humanized at MedImmune and is licensed for prevention of serious lower respiratory tract disease caused by RSV in high-risk pediatric patients.  She began her career as a post-doctoral fellow in the laboratory of Dr. Robert Webster in the Division of Virology at St. Jude Childrens’ Research Hospital, Memphis, TN.

Dr. Coelingh earned her bachelor’s degree in biology from Calvin College and her doctorate degree in epidemiologic science from the University of Michigan.

Manon M. J. Cox, PhD, MBA

Protein Sciences

Dr. Cox joined Protein Sciences in 1998 as Director of Business Development, became Chief Operating Officer in 2000 and became CEO in 2010. Previously, she was with Gist-brocades, a Dutch company specializing in fermentation. She held various management positions at Gist-brocades, including in Research and Development, Manufacturing and Business Development. She serves on the Scientific Advisory Boards of Pall BioPharmaceuticals and iCubed, the Board of Directors of United Way, Meriden & Wallingford, and the Education Committee of the Netherlands-America Foundation. Dr. Cox holds a Doctorate from the University of Wageningen, received her MBA with distinction from the University of Nijenrode and the University of Rochester, NY and holds a Doctorandus degree in Molecular Biology, Genetics and Biochemistry from the University of Nijmegen, The Netherlands.

Ruben Donis, PhD

Centers for Disease Control and Prevention

Ruben Donis, DVM, PhD, serves as the Associate Director for Policy, Evaluation and Preparedness for the CDC's Influenza Division. Formerly, Dr. Donis served as chief of the Molecular Virology and Vaccines Branch in the Influenza Division.

Dr. Donis earned his Veterinary Medicine diploma from the University of Buenos Aires and his PhD in Virology from Cornell University. He completed his postdoctoral work at St. Jude Children's Research Hospital, where he specialized in influenza molecular virology. Prior to joining CDC in 2003, Dr. Donis served on the faculty of the University of Nebraska-Lincoln, where he participated in the leadership of the UNL Center for Biotechnology, and conducted research on influenza and flavivirus molecular biology.

At CDC, Dr. Donis oversees pandemic risk assessment studies that analyze structural, functional and epidemiological properties of emerging influenza viruses and coordinates vaccine preparedness activities. He also integrates collaborations with partners, including the WHO, OIE and FAO, to monitor the evolution and pandemic potential of animal influenza viruses and develop candidate viruses for vaccine production. Dr. Donis has more than 25 years of research experience with influenza virus molecular biology and virus-host interactions. Dr. Donis also serves as an adjunct professor of microbiology at Emory University.

Philip R. Dormitzer, MD, PhD

Novartis Vaccines and Diagnostics

Philip R. Dormitzer, MD, PhD is Head of US Research, Global Head of Virology, and Vice President at Novartis Vaccines and Diagnostics in Cambridge, Massachusetts. He is a practicing physician, who is board certified in Internal Medicine. After studying anthropology at Harvard College and carrying out a field study of the Efe Pygmies in the Ituri Forest of Zaire, he completed his M.D. and Ph.D. in Cancer Biology at Stanford University.  Dr. Dormitzer completed house-staff training in Internal Medicine at Massachusetts General Hospital and a fellowship in the Harvard Combined Infectious Diseases Training Program.  As an Assistant Professor of Pediatrics at Harvard Medical School, Dr. Dormitzer led a structural virology laboratory that determined the structures of the rotavirus neutralization antigens. At NV&D, Dr. Dormitzer has held positions leading vaccine research and development teams. In 2009, he led the research component of the Novartis response to the H1N1v influenza pandemic, supporting the development and licensure of three pandemic influenza vaccines in the most rapid vaccine response in history.  Dr. Dormitzer’s research team of approximately 80 scientists, most based at the NV&D Cambridge Research Center, work on next generation vaccines against influenza, respiratory syncytial virus, parvovirus B19, and cytomegalovirus, among other targets.

David P. Greenberg, MD

Sanofi Pasteur US

David P. Greenberg, MD, is Vice President of Scientific and Medical Affairs and Chief Medical Officer for Sanofi Pasteur US located in Swiftwater, PA. He joined the company 9 years ago, after serving as Associate Professor of Pediatrics at the University of Pittsburgh School of Medicine and Director of the Center for Vaccine Research at Children’s Hospital of Pittsburgh from 1996 to 2004. He continues his affiliation with the University of Pittsburgh as an Adjunct Associate Professor of Pediatrics. After completing training in Pediatrics and Pediatric Infectious Diseases, Dr. Greenberg served on the faculty of the Department of Pediatrics at Harbor-UCLA Medical Center in Los Angeles from 1985 to 1996. Dr. Greenberg has extensive experience in clinical and laboratory-based infectious disease research. His clinical research interests have focused on evaluating the safety and immunogenicity of bacterial and viral vaccines for the prevention of infections caused by Bordetella pertussis, Haemophilus influenzae type b, Neisseria meningitidis, influenza, hepatitis B, polio, and others. Dr. Greenberg has published his original research in well over 50 peer-reviewed articles. He is a fellow of both the Infectious Diseases Society of America and the American Academy of Pediatrics and a member of the American Pediatric Society, Society for Pediatric Research, Pediatric Infectious Diseases Society, and American Society for Microbiology.

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Abstracts

Keynote Speaker Abstract

Influenza: Epidemiology, Molecular Aspects and Vaccine Effectiveness
Nancy J. Cox, Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention

The isolation of influenza A virus in 1933 led to the identification of influenza viruses as the cause of previous epidemics and pandemics of respiratory disease and to the development, testing and first use of influenza vaccines in the 1930s and 1940s. During seasonal epidemics, large numbers of influenza infections can occur in all age groups. Influenza pandemics can be associated with higher rates of illness and death than those for seasonal influenza. Few other infectious diseases have adversely affected the health and economics of global populations as consistently and extensively as influenza. One reason for the continuing impact of influenza is the ability of influenza A and B viruses to undergo antigenic change in the two surface glycoproteins, hemagglutinin and neuraminidase against which protective antibodies are directed.  The second reason is the unpredictable emergence and spread in humans of new influenza A subtypes that previously only infected animal populations. Molecular epidemiology coupled with gain of function studies have greatly elucidated the mechanisms involved in antigenic drift and in the emergence of novel influenza A subtypes.  Such studies have also informed our understanding of influenza virus evolution, the selection of vaccine viruses and the variable estimates of the efficacy and effectiveness of influenza vaccines.
 

Speaker Abstracts

Pandemic Influenza Risk Assessment and Vaccine Development
Ruben Donis, DVM, PhD, Centers for Disease Control and Prevention

The success of pandemic mitigation is predicated on the timeliness of our public health interventions, especially for vaccination. Effective virologic and epidemiologic surveillance to monitor zoonotic infections and changes in the circulating animal influenza viruses are critical to identify an emerging pandemic virus as early as possible. Highly pathogenic avian influenza A(H5N1) remains endemic in several regions of Asia and Africa and continues to evolve defying ongoing control efforts by the animal health sector. Avian influenza A(H7N9) has emerged in China and although closure of live bird markets has reduced human infections, further surveillance is needed to assess its distribution in birds. Although significant progress in global surveillance at the animal human interface has been achieved through intersectoral collaboration, sizable gaps remain a challenge that will require renewed efforts by the international community. Substantial progress has been achieved in pandemic vaccination and antigen sparing strategies, some motivated by lessons learned from the 2009 H1N1 pandemic response. Pandemic vaccine preparedness has improved thorough the application of new technologies such as recombinant HA expression, gene synthesis and the use of reverse genetics to strengthen established live attenuated and inactivated/subunit vaccine platforms.
 

Individualized Influenza Vaccines: Quadrivalent, Intradermal and High-Dose
David P. Greenberg, Sanofi Pasteur US

Sanofi Pasteur has had a long-standing commitment to develop, study, and license innovative influenza vaccines and delivery options to help protect as many people as possible against influenza disease and influenza-associated complications and death. To this end, we have brought several new influenza vaccines to the US market in recent years: Fluzone® High-Dose (Influenza Virus Vaccine; 2009), Fluzone Intradermal vaccine (2011), and Fluzone Quadrivalent vaccine (2013). Fluzone High-Dose vaccine is formulated with four times the quantity of hemagglutinin (HA) compared with Fluzone vaccine (60 mcg HA/strain vs 15 mcg HA/strain). It was licensed by the US Food and Drug Administration for use in seniors 65 years of age and older based on the results of a Phase III study demonstrating the vaccine’s safety profile and its superior immunogenicity to the A/H1N1 and A/H3N2 strains compared with Fluzone vaccine and with the objective of providing better protection in this vulnerable population. We recently completed a two-year, multi-center, randomized, controlled, and blinded efficacy trial of over 30,000 participants at least 65 years of age in which Fluzone High-Dose vaccine offered 24.2% better protection than Fluzone vaccine against symptomatic laboratory-confirmed influenza caused by any viral type or subtype, meeting the pre-specified criterion for demonstrating superior clinical benefit (data will be submitted to FDA in early 2014). For younger adults 18 through 64 years of age, Fluzone Intradermal vaccine was developed to take advantage of the rich immune milieu of the dermis and to provide an alternative to the traditional intramuscular injection by utilizing a tiny 30 gauge microneedle that reliably deposits antigen intradermally. For persons across a wide age spectrum (6 months of age and older), Fluzone Quadrivalent vaccine was distributed for the first time this year, helping to protect against two immunologically distinct influenza B lineages (Victoria and Yamagata) simultaneously. Because both B lineages co-circulate each year in the US, quadrivalent vaccines avoid B lineage mismatches that often occur with trivalent vaccines, which contain only one B lineage strain. Fluzone and Fluzone Quadrivalent vaccines are the only influenza vaccines licensed in the US for children as young as 6 months of age (0.25 mL dose). Finally, Sanofi Pasteur has demonstrated its commitment to pandemic preparedness by licensing H5N1 vaccines in the US and elsewhere, and we have manufactured investigational vaccines against other potentially pandemic strains, including H3N2v, H7N7, and H7N9. Our long-term goal has been to help raise influenza immunization rates worldwide and to optimize protection by offering a number of different vaccines to address the varied preferences and needs of healthcare providers and patients.
 

Live Attenuated Influenza Vaccine: 2013 Update
Kathy Coelingh, MedImmune

The nasal live attenuated influenza vaccine (LAIV) has been licensed since 2003 in the United States, and is indicated for healthy non-pregnant persons 2 - 49 years of age.  For the 2013-14 influenza season, a 4-strain LAIV formulation (FluMist Quadrivalent®) containing 2 A strains and 2 B strains will replace the trivalent formulation. The scientific rationale and clinical data to support the quadrivalent LAIV will be presented. In addition, clinical data on LAIV containing antigens of pandemic potential will be summarized.
 

Flublok®: The First Recombinant Influenza Vaccine Approved by the FDA
Manon M.J. Cox, Protein Sciences

A Biologics License Application (BLA) for approval of FluBlok, a new recombinant influenza vaccine for the prevention of the “flu”, was filed in 2008. The speaker will discuss Flublok, the first FDA approved recombinant influenza vaccine
 
Flublok is a recombinant hemagglutinin influenza vaccine produced in this production platform and provides an attractive alternative to the current egg-based influenza vaccine (TIV) manufacturing process. Protein Sciences Corporation was awarded a contract in June 2009 from the U.S. Department of Health and Human Services to further develop this technology for the production of recombinant influenza vaccines for pandemic preparedness and FDA granted approval of Flublok for the prevention of influenza in adults (18 - 49 Years) on January 16, 2013.
 
The speaker will discuss the challenges a small biotech company we encountered on our path to approval, manufacturing and commercialization of Flublok.
 

Improving Influenza Immunization with Synthetic Vaccine Viruses
Philip R. Dormitzer, Novartis Vaccines and Diagnostics

Most influenza vaccines on the market today are produced with technology that is more than 40 years old. Influenza viruses isolated from human subjects are shipped around the world, adapted to eggs, reassorted in eggs, and then expanded in hundreds of millions of eggs to produce vaccines. Many strains will not grow in eggs, and the process of adaptation to eggs often leads to mutations in antigenic regions of HA. During the 2012-13 northern hemisphere season an antigenic mismatch between the H3N2 vaccine strain and circulating strains due to egg adaptation was associated with disappointing efficaciousness. A switch to isolation of seed viruses in mammalian MDCK cells and production in MDCK cells can address that situation. Flucelvax, a vaccine produced in MDCK cells, was recently licensed in the US, and an international group of collaborators is working to change the substrate for vaccine seed virus isolation from eggs to mammalian cells. The current system of seed generation and vaccine production is also too slow for effective pandemic responses, as demonstrated during the 2009 pandemic, when substantial quantities of vaccine were only available after the second pandemic wave had peaked. In collaboration with BARDA, Synthetic Genomics Inc., and the J. Craig Venter Institute, we have developed a synthetic system of vaccine virus generation. Rapid and accurate gene synthesis, improved backbones, and optimized virus rescue in MDCK cells allow the generation of high yielding vaccine viruses 5 days after new HA and NA gene sequences are received. This advance has the potential not only to reduce the likelihood of mismatched vaccine strains, but also to transform and to simplify the influenza vaccine strain generation system by eliminating the need to ship viruses across international borders, isolate viruses in eggs, conduct reassortment, and delay vaccine production while waiting for viruses to be distributed to manufacturers.
 

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