Vaccine
-
A clear vision for vaccines research and development (R&D) is needed if Europe is to continue to lead the discovery of next generation vaccines. Innovation Partnership for a Roadmap on Vaccines in Europe (IPROVE) is a collaboration between leading vaccine experts to develop a roadmap setting out how Europe can best invest in the science and technology essential for vaccines innovation. This FP7 project, started in December 2013, brought together more than 130 key public and private stakeholders from academia, public health institutes, regulators, industry and small and medium-sized enterprises to determine and prioritise the gaps and challenges to be addressed to bolster innovation in vaccines and vaccination in Europe. ⋯ Bringing together a wide range of stakeholders to work on the IPROVE roadmap has increased mutual understanding of their different perspectives, needs and priorities. IPROVE is a first attempt to develop such a comprehensive view of the vaccine sector. This prioritisation effort, aims to help policy-makers and funders identify those vaccine-related areas and technologies where key investment is needed for short and medium-long term success.
-
Review Historical Article
Measles and Rubella Global Strategic Plan 2012-2020 midterm review report: Background and summary.
Measles, a vaccine-preventable illness, is one of the most infectious diseases known to man. In 2015, an estimated 134,200 measles deaths occurred globally. Rubella, also vaccine-preventable, is a concern because infection during pregnancy can result in congenital defects in the baby. ⋯ It recommended that countries continue to work toward elimination goals with a focus on strengthening ongoing immunization systems. In addition, it concluded that the strategies articulated in the Plan were sound, however full implementation had been impeded by inadequate country ownership and global political will, reflected in inadequate resources. Detailed recommendations for each of the Plan's five strategies as well as the areas of polio transition, governance and resource mobilization are outlined.
-
Global immunization efforts to date have heavily focused on infants and children, with noted success on public health. Healthy adolescents and adults contribute to the economic growth and development of countries but efforts to ensure vaccine coverage for these groups receive inadequate global attention and resources. Emerging epidemics for a number of infectious diseases including Ebola, Zika, dengue, malaria and the continuing epidemics of tuberculosis and several sexually transmitted infections, including HIV, HPV and Hepatitis B, have high incidence and prevalence in adolescents and adults. ⋯ Global consensus, political will, policies, global and country infrastructure, and financing mechanisms are needed to accelerate access for the billions of adolescents and adults living under the threat of devastating infectious disease outbreaks and epidemics, especially in lower income countries. The global health community and countries cannot afford to delay planning for implementation of adolescent and adult vaccine programs that will potentially save millions of lives and strengthen global and national economies. The article examines this next challenge and suggests a research agenda and a framework for action to galvanize global and national policy decision-makers to begin preparations for future immunization challenges.
-
Since December 2015, the first dengue vaccine has been licensed in several Asian and Latin American countries for protection against disease from all four dengue virus serotypes. While the vaccine demonstrated an overall good safety and efficacy profile in clinical trials, some key research questions remain which make risk-benefit-assessment for some populations difficult. As for any new vaccine, several questions, such as very rare adverse events following immunization, duration of vaccine-induced protection and effectiveness when used in public health programs, will be addressed by post-licensure studies and by data from national surveillance systems after the vaccine has been introduced. ⋯ In this paper, we summarize scientific and methodological considerations for public health surveillance and targeted post-licensure studies to address some key research questions related to live-attenuated dengue vaccines. Countries intending to introduce a dengue vaccine should assess their capacities to monitor and evaluate the vaccine's effectiveness and safety and, where appropriate and possible, enhance their surveillance systems accordingly. Targeted studies are needed, especially to better understand the effects of vaccinating seronegative individuals.
-
Review
Regulatory considerations in development of vaccines to prevent disease caused by Chikungunya virus.
Chikungunya virus (CHIKV) is a mosquito-transmitted alphavirus. Chikungunya disease (CHIK) in humans is characterized by sudden onset of high fever, cutaneous rash, myalgia and debilitating polyarthralgia. Until recently the virus was considered endemic to only Africa and Asia, but since 2004 CHIK has spread to previously non-endemic regions, including Europe and the Americas, thereby emerging as a global health threat. ⋯ If "traditional approval" following demonstration of direct benefit in adequate and well-controlled clinical disease endpoint studies is not possible, the Accelerated Approval and Animal Rule pathways are potential alternatives. In terms of vaccine safety, the potential for vaccine associated arthralgia and antibody-dependent enhancement of infectivity and disease severity are important issues that should be addressed in both pre-clinical and clinical studies. CHIK vaccine developers are encouraged to communicate with the FDA during all stages of vaccine development.