Baylor College of Medicine (BCM)
United States of America
Dr Muñoz-Rivas has dedicated the last 18 years to research and implementation of maternal immunization. She has been the Principal Investigator for several interventional clinical trials of vaccines in pregnant women, including RSV vaccine, pneumococcal, tetanus, Hemophilus influenza type b, seasonal influenza, H1N1 influenza and Tdap. She has carried out epidemiologic and safety studies of influenza vaccine in pregnancy. She has worked as a consultant with the US Centers for Disease Control and Prevention on Pandemic Preparedness in Pregnant women (before the 2009 pandemic); with the US National Institutes of Health in the development of guidelines and definitions for studies of vaccines in pregnancy under the Division of Microbiology and Infectious Diseases (2011-to date); with the American College of Obstetrics and Gynecology as a member of the Immunization Expert group since its inception in 2011; with the Brighton Collaboration as a member of the group which is developing definitions for the assessment of safety in studies of vaccines in pregnant women and neonates (since 2003); and more recently, with the World Health Organization and the Brighton Collaboration in the development and harmonization of definitions for the assessment of safety of immunization during pregnancy in mothers and infants (2014).
Contribution to the consortium
Baylor College of Medicine coordinated the development of all neonatal case definitions and will continue to do so. BCM involvement in all connected activities (e.g., CRF templates, definition mapper) is derived from the in depth knowledge of all neonatal case definitions. BCM also brings background to the development of the case based causality assessment guidance and the ORA Tool and is thus a key member to these tasks. BCM has tradition in conducting MI trials and it may leverage its large network of trialists to identify on-going studies, encourage use of GAIA outputs and solicit feedback on their impact.