Lewis Markoff

Dr. Markoff is a widely known virologist with special expertise in vaccine development and regulatory science. He has more than 40 years of experience in these fields. As detailed, below, he retired from the US Food & Drug Administration after 27 years’ service in a senior position in the Division of Viral Products, Center for Biologics Evaluation and Research (CBER). Prior thereto he was Senior Investigator with tenure at the National Institute for Allergy and Infectious Diseases, NIH.

Dr. Markoff received his BA degree from Amherst College and his MD from Albert Einstein College of Medicine. While at Einstein, he also obtained pre-doctoral training as a molecular biologist. He is board-certified in the specialties of Internal Medicine and Infectious Diseases.

Dr. Markoff began his scientific career in the mid-1970s at the National Institute for Allergy and Infectious Diseases, NIH, where he held the position of Senior Investigator with tenure. While at NIH, Dr. Markoff participated in a program to create and test candidate live, attenuated influenza A viruses. He was active in all aspects of this program, from the generation and in vitro characterization of mutant viruses at the lab bench to phase I clinical testing of promising vaccine candidates. He also created the first cloned DNA copy of N2 neuraminidase (NA) gene and performed in vitro studies that assigned the NA to a new class of glycoproteins, based on its membrane orientation. While at NIH in the late 1980s, Dr. Markoff turned his attention to dengue virus, especially dengue vaccine development, based on its re-emergence as a major public health threat in Asian and South American countries, at that time. He undertook an analysis of the antigenicity of peptides derived from the amino acid sequence of the dengue Envelope protein and was invited to present the results at a Cold Spring Harbor Symposium. For this work, Dr. Markoff received an NIH Outstanding Service Medal in 1989. He also published evidence to suggest that bleeding in uncomplicated dengue fever may be due to the generation of a transient cross-reactive immune response to plasminogen.

In 1991, Dr. Markoff accepted a position at the Center for Biologics Evaluation and Research (CBER), FDA, in order to start a new laboratory devoted to vector-borne viruses, especially flaviviruses, such as dengue, West Nile, Japanese Encephalitis, Zika, and Yellow Fever viruses, and alphaviruses, such as Chikungunya and the New World alphaviruses. As Chief of the new laboratory, Dr. Markoff was also expected to take charge of all reviews and regulations of vaccines aimed at any of these pathogens. Members of the laboratory also performed as FDA reviewers as part of their work responsibilities. The thrust of Dr. Markoff’s research effort at FDA was aimed at the safety and efficacy of live flavivirus vaccines, especially dengue and West Nile vaccines. One byproduct of the research effort was the creation of an attenuated DENV1 virus that now constitutes one of the four live, attenuated vaccine viruses in the NIH tetravalent dengue vaccine. In the course of his work at FDA, Dr. Markoff also participated in several internal Working Groups designated to address urgent issues of the moment; the subjects included Counter-Terrorism, Animal Rule, Zika Animal Models, adverse events associated with YF17D vaccines (in collaboration with CDC colleagues), and Emerging Pathogens. He represented FDA as a member of the WHO Steering Committee on Dengue and Japanese Encephalitis Virus Vaccine Development and thus participated extensively in the development of WHO guidelines related to clinical trials of novel dengue vaccines in endemic areas. During his years at FDA, Dr. Markoff received several awards in recognition of his contributions. He retired from his position as lab chief at FDA at the end of December 2017.

During his career at NIH and FDA, Dr. Markoff authored more than 60 scientific papers published in peer-reviewed journals. He is the holder of three patents.