From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary
International Journal of Health Governance
Volume 22 Issue 2 2017
A review of policy, practices, and players governing and involved in the United States vaccine and immunization enterprise
Angela K Shen, Alice Y. Tsai, Gus Birkhead
This paper outlines the organization and governance of the U.S. vaccine and immunization enterprise. It describes the major components of the U.S. system including the various relationships between major federal government entities, stakeholders, and advisory committees that inform government policymaking at various points in the system.
We describe the complex interdependent network of partners that engage in a wide range of activities such as disease surveillance, research, vaccine development, regulatory licensure, practice recommendations, financing, service delivery, communications and post-licensure monitoring.
The U.S. system of governance is highly participatory and focuses on a transparent and open engagement, with input from a wide range of partners to inform decision-making. This collaborative framework allows many inputs to be heard and helps support the U.S. vaccine and immunization system as it evolves to meet the continued public health needs in the U.S. through the optimal use of safe and effective vaccines.
Invited article on the US vaccine and immunization enterprise. The development and availability of vaccines in the United States has had profound impact on mortality and morbidity and public health (Centers for Disease Control & Prevention, 2011). The success of this enterprise is a result of a blended public and private sector system with partnerships at the federal, state and local levels of government to optimize the use of safe and effective vaccines. Governance structures have been established to support the interaction and decision-making among the federal and non-federal actors toward the common goal of controlling and preventing infectious diseases.
Open Forum Infectious Diseases
Published: 18 July 2017
Vaccine rejection and hesitancy: a review and call to action
TC Smith –
Vaccine refusal has been a recurring story in the media for well over a decade. Though there is scant evidence that refusal is genuinely increasing in the population, multiple studies have demonstrated concerning patterns of decline of confidence in vaccines, the medical professionals who administer vaccines, and the scientists who study and develop vaccines. As specialists in microbiology, immunology, and infectious diseases, scientists are content experts but often lack the direct contact with individuals considering vaccination for themselves or their children that healthcare professionals have daily. This review examines the arguments and players in the United States anti-vaccination scene, and discusses ways that experts in infectious diseases can become more active in promoting vaccination to friends, family, and the public at large.
Current Opinion in Infectious Diseases
Post Author Corrections: July 14, 2017
Dengue vaccines: implications for dengue control
Robinson, Matthew L.; Durbin, Anna P.
Purpose of review: Dengue, the most common arbovirus, is an increasingly significant cause of morbidity worldwide. After decades of research, an approved tetravalent dengue vaccine is finally available. Models constructed using recently available vaccine efficacy data allow for a data-driven discussion of the potential impact of dengue vaccine deployment on global control.
Recent findings: Phase 3 efficacy trials demonstrated that the approved dengue vaccine, chimeric yellow fever-dengue-tetravalent dengue vaccine, has an efficacy of 60% against dengue illness of any severity. However, among dengue unexposed recipients, vaccination offers limited efficacy and may increase dengue severity. The WHO consequently recommends dengue vaccination for populations in which 70% of intended recipients are dengue seropositive. Models predict that routine childhood dengue vaccine may reduce dengue burden, but over time, population-level impact may be limited. Additional vaccine candidates in late-stage development may not suffer from the same limitations as chimeric yellow fever-dengue-tetravalent dengue vaccine.
Summary: The efficacy and safety profile of the recently approved dengue vaccine is favorable only in previously dengue exposed recipients, which limits its potential for global control. Future work must evaluate the approved vaccine’s long-term durability, efficacy of other late phase vaccine candidates, and potential for vector control efforts to work synergistically with vaccine deployment.
Cold Spring Harbor Perspectives in Biology
Early Release Articles Last updated July 17, 2017
Immune Memory and Vaccines: Great Debates – Which Dengue Vaccine Approach Is the Most Promising, and Should We Be Concerned about Enhanced Disease after Vaccination?: The Path to a Dengue Vaccine: Learning from Human Natural Dengue Infection Studies and Vaccine Trials
Aravinda M. de Silva and Eva Harris
Cold Spring Harb Perspect Biol doi:10.1101/cshperspect.a029371
Dengue virus (DENV) is the most common arthropod-borne viral disease of humans. Although effective vaccines exist against other flaviviral diseases like yellow fever and Japanese encephalitis, dengue vaccine development is complicated by the presence of four virus serotypes and the possibility of partial immunity enhancing dengue disease severity. Several live attenuated dengue vaccines are being tested in human clinical trials. Initial results are mixed, with variable efficacy depending on DENV serotype and previous DENV exposure. Here, we highlight recent discoveries about the human antibody response to DENV and propose guidelines for advancing development of safe and effective dengue vaccines.
Immune Memory and Vaccines: Great Debates – Which Dengue Vaccine Approach Is the Most Promising, and Should We Be Concerned about Enhanced Disease after Vaccination?: Questions Raised by the Development and Implementation of Dengue Vaccines: Example of the Sanofi Pasteur Tetravalent Dengue Vaccine
Cold Spring Harb Perspect Biol doi:10.1101/cshperspect.a029462
Dengue is a still-growing public health concern in many tropical and subtropical regions of the world. The development and implementation of an effective dengue vaccine in these regions is a high priority. This insight focuses on the expected characteristics of a safe and efficacious vaccine, referring to the clinical experience obtained during the development of the first tetravalent dengue vaccine from Sanofi Pasteur, now licensed in several endemic countries. Safety and efficacy data from both short- and long-term follow-up of large-scale efficacy studies will be discussed, as well as the next steps following vaccine introduction.
Immune Memory and Vaccines: Great Debates – Which Dengue Vaccine Approach Is the Most Promising, and Should We Be Concerned about Enhanced Disease after Vaccination?: There Is Only One True Winner
Scott B. Halstead
Cold Spring Harb Perspect Biol doi:10.1101/cshperspect.a030700
The scientific community now possesses information obtained directly from human beings that makes it possible to understand why breakthrough-enhanced dengue virus (DENV) infections occurred in children receiving Sanofi Pasteur’s Dengvaxia tetravalent live attenuated vaccine and to predict the possibility of breakthrough-enhanced DENV infections following immunization with two other tetravalent live attenuated vaccines now in phase III testing. Based upon recent research, Dengvaxia, lacking DENV nonstructural protein antigens, did not protect seronegatives because it failed to raise a competent T-cell response and/or antibodies to NS1. It is also possible that chimeric structure does not present the correct virion conformation permitting the development of protective neutralizing antibodies. A premonitory signal shared by the Sanofi Pasteur and the Takeda vaccines was the failure of fully immunized subhuman primates to prevent low-level viremia and/or anamnestic antibody responses to live DENV challenge. The vaccine developed by the National Institute of Allergy and Infectious Diseases (National Institutes of Health [NIH]) has met virtually all of the goals needed to demonstrate preclinical efficacy and safety for humans. Each monovalent vaccine was comprehensively studied for reactogenicity and immunogenicity in human volunteers. Protective immunity in subjects receiving tetravalent candidate vaccines was evidenced by the fact that when vaccinated subjects were given further doses of vaccine or different strains of DENV the result was “solid immunity,” a nonviremic and nonanamnestic immune response.
Immune Memory and Vaccines: Great Debates – Which Dengue Vaccine Approach Is the Most Promising, and Should We Be Concerned about Enhanced Disease after Vaccination?: The Risks of Incomplete Immunity to Dengue Virus Revealed by Vaccination
Stephen S. Whitehead and Kanta Subbarao
Cold Spring Harb Perspect Biol doi:10.1101/cshperspect.a028811
Immune enhancement of dengue disease continues to be a concern for those with incomplete immunity in endemic areas. Advanced testing and follow-up of a newly available live attenuated dengue vaccine has recently shown the ability of vaccination to predispose some recipients for a severe outcome on subsequent infection. To improve safety, recommendations have been made to restrict use of the vaccine to those who are likely to have had prior exposure to dengue virus (DENV). Researchers continue to investigate dengue immunity and seek evidence that dengue vaccines can be safely administered to all populations needing protection.
Immune Memory and Vaccines: Great Debates – Which Dengue Vaccine Approach Is the Most Promising, and Should We Be Concerned about Enhanced Disease after Vaccination?: The Challenges of a Dengue Vaccine
Gavin Screaton and Juthathip Mongkolsapaya
Cold Spring Harb Perspect Biol doi:10.1101/cshperspect.a029520
A dengue vaccine has been pursued for more than 50 years and, unlike other flaviviral vaccines such as that against yellow fever, progress has been slow. In this review, we describe progress toward the first licensed dengue vaccine Dengvaxia, which does not give complete protection against disease. The antibody response to the dengue virion is reviewed, highlighting immunodominant yet poorly neutralizing responses in the context of a highly dynamic structurally flexible dengue virus particle. Finally, we review recent evidence for cross-reactivity between antibody responses to Zika and dengue viruses, which may further complicate the development of broadly protective dengue virus vaccines.