Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response

Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely – and at times uniquely – affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response efforts to combat emerging and re-emerging infectious diseases. Historically, pregnant women and their offspring have been largely excluded from research agendas and investment strategies for vaccines against epidemic threats, which in turn can lead to exclusion from future vaccine campaigns amidst outbreaks. This state of affairs is profoundly unjust to pregnant women and their offspring, and deeply problematic from the standpoint of public health. To ensure that the needs of pregnant women and their offspring are fairly addressed, new approaches to public health preparedness, vaccine research and development, and vaccine delivery are required. This Guidance offers 22 concrete recommendations that provide a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The Guidance was developed by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group – a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy – in consultation with a variety of external experts and stakeholders.Fil: Krubiner, Carleigh B.. University Johns Hopkins; Estados UnidosFil: Faden, Ruth R.. University Johns Hopkins; Estados UnidosFil: Karron, Ruth A.. University Johns Hopkins; Estados UnidosFil: Little, Margaret O.. University Of Georgetown; Estados UnidosFil: Lyerly, Anne D.. University of North Carolina; Estados UnidosFil: Abramson, Jon S.. University Wake Forest; Estados UnidosFil: Beigi, Richard H.. Magee-Womens Hospital of University of Pittsburgh Medical Center; Estados UnidosFil: Cravioto, Alejandro R.. Universidad Nacional Autónoma de México; MéxicoFil: Durbin, Anna P.. University Johns Hopkins; Estados UnidosFil: Gellin, Bruce G.. Sabin Vaccine Institute; Estados UnidosFil: Gupta, Swati B.. IAVI; Estados UnidosFil: Kaslow, David C.. PATH; Estados UnidosFil: Kochhar, Sonali. Global Healthcare Consulting; IndiaFil: Luna, Florencia. Facultad Latinoamericana de Ciencias Sociales; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Saenz, Carla. Pan American Health Organization; Estados UnidosFil: Sheffield, Jeanne S.. University Johns Hopkins; Estados UnidosFil: Tindana, Paulina O.. Navrongo Health Research Centre; GhanaFil: The Prevent Working Group. No especifíca

A Research and Development (R&D) roadmap for influenza vaccines: Looking toward the future

Improved influenza vaccines are urgently needed to reduce the burden of seasonal influenza and to ensure a rapid and effective public-health response to future influenza pandemics. The Influenza Vaccines Research and Development (R&D) Roadmap (IVR) was created, through an extensive international stakeholder engagement process, to promote influenza vaccine R&D. The roadmap covers a 10-year timeframe and is organized into six sections: virology; immunology; vaccinology for seasonal influenza vaccines; vaccinology for universal influenza vaccines; animal and human influenza virus infection models; and policy, finance, and regulation. Each section identifies barriers, gaps, strategic goals, milestones, and additional R&D priorities germane to that area. The roadmap includes 113 specific R&D milestones, 37 of which have been designated high priority by the IVR expert taskforce. This report summarizes the major issues and priority areas of research outlined in the IVR. By identifying the key issues and steps to address them, the roadmap not only encourages research aimed at new solutions, but also provides guidance on the use of innovative tools to drive breakthroughs in influenza vaccine R&D.publishedVersio

The National Vaccine Advisory Committee At 30: Impact And Opportunity

Thirty years after passage of legislation that created the National Vaccine Advisory Committee (NVAC) “to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines,” this review reflects NVAC\u27s role and impact on the U.S. vaccine and immunization enterprise as an external advisor to the Department of Health and Human Services. We reviewed the history of NVAC in the context of the principles of its establishment, with a focus on its reports and recommendations. We performed a systematic literature review to identify NVAC reports published in widely-accessible public health journals, and we reviewed the available archives to identify other reports and resolutions approved by the committee not published in journals. We characterized key issues considered by NVAC according to the five goals of the 2010 National Vaccine Plan. The predominance of NVAC activities to date related to the implementation of immunization across the lifespan and the many aspects of the system needed to foster the goal of full immunization. Reflecting on the impacts of NVAC to date, this review identified 30 NVAC approved reports published in journals, 22 stand-alone resolutions, and 26 unique unpublished reports. The development of new and improved vaccines continues to represent a significant priority for NVAC, and we identified several challenges related to future vaccine innovation. Given the many factors that impact on policy changes in the vaccine and immunization enterprise, we encountered challenges associated with demonstrating attribution of specific policy changes to NVAC recommendations. Although difficult to quantify, this review suggests that NVAC played an important role in the improvements in the U.S. immunization enterprise over the past 30 years and that NVAC can and will continue to play an important role supporting U.S. immunization going forward