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Vaccine Safety Communication eLibrary

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  1. Dengue vaccines have been under development since the 1940s, but due to the limited appreciation of global dengue disease burden and of the potential markets for dengue vaccines, the industry’s interest languished throughout much of the 20th century. In recent years, however, the development of dengue vaccines has accelerated dramatically. Sanofi Pasteur’s Dengvaxia® became the first dengue vaccine to be licensed for use in 2015. Today, several other vaccines are in various stages of advanced development, with clinical trials currently underway. Vaccine development for dengue is particularly challenging because dengue fever is caused by one of four related, but distinct, virus serotypes (DENV 1-4). While recovery from infection by one virus provides lifelong immunity against that virus, it provides only partial and transient immunity against the other three. For vaccine development, this means that an effective vaccine against dengue needs to be tetravalent, providing protection against all four dengue viruses. Dengue vaccines will complement, but not replace, prevention methods, such as vector control, already in place. According to the WHO, drawing on the experiences of other vaccine-preventable vector-borne diseases, effective surveillance, prevention and outbreak response tools (vector control and vaccines) must continue to complement each other in reducing the burden of the disease.
  2. Serie of questions and answers such as : What is RTS,S/AS01? What makes RTS,S different from malaria vaccine candidates currently under development? What is the efficacy of the RTS,S vaccine?
  3. The efficacy and safety of the RTS,S/AS01 candidate malaria vaccine during 18 months of follow-up have been published previously. Herein, we report the final results from the same trial, including the efficacy of a booster dose.
  4. This document takes into account new and unpublished data that were communicated by Sanofi Pasteur to WHO in November-December 2017. WHO published the recommendations of the Strategic Advisory Group of Experts on Immunization (SAGE) on the use of Dengvaxia® on 27 May 2016 (1), and subsequently a WHO position paper on dengue vaccine on 29 July 2016 (2). Following the disclosure to WHO of new data on Dengvaxia® by its manufacturer, Sanofi Pasteur, as described in more detail below, WHO has initiated a process engaging independent external experts to review the data in detail. This process is expected to lead to revised recommendations from SAGE in April 2018, and to an updated WHO position paper on dengue vaccine thereafter. The purpose of this document, prepared by the WHO Secretariat, is to supplement the WHO position paper on Dengvaxia® of July 2016 until WHO has issued an updated position paper on dengue vaccine, based on advice by SAGE. WHO Secretariat recommends that the July 2016 position paper be read in conjunction with this document. This document replaces a questions and answers document web-posted by WHO on 30 November 2017.
  5. The reconvened Dengue Working Group is asked to review new data on the long-term follow-up of dengue vaccine recipients. This includes data generated by further laboratory testing and analysis related to the long-term safety and efficacy of CYD-TDV Phase 3 trial participants. In particular, the group is asked to review the differential performance of the CYD-TDV vaccine (also known as Dengvaxia®) in subjects seronegative versus seropositive at the time of vaccination. The group is asked to advise on a revision of WHO’s current vaccine recommendations as published in July 2016. The review at SAGE is tentatively scheduled for April 2018. This will lead to the publication of an amended WHO position paper on the use of a dengue vaccine, which will replace the interim recommendation issued by WHO on 22 Dec 2017 (WHO interim position on the use of Dengvaxia®)
  6. WHO published the recommendations of the Strategic Advisory Group of Experts on Immunization (SAGE) on the use of Dengvaxia® on 27 May 2016, and subsequently a WHO position paper on dengue vaccine on 29 July 2016. Following the disclosure of new data on Dengvaxia® by its manufacturer, Sanofi Pasteur, on 29 November 2017 (as described in more detail below), WHO`s Global Advisory Committee on Vaccine Safety (GACVS) and the WHO Secretariat published interim statements on December 7, 2017, and December 22, 2017, respectively. WHO initiated a process engaging independent external experts to review the data in detail, and reconvened the SAGE working group on dengue vaccines. This process has led to revised recommendations from SAGE on 18 April 2018. An updated WHO position paper on dengue vaccine will be published in September 2018. The purpose of this document is to supplement the WHO ”Question and Answer” document from December 22, 2017
  7. At the November 2011 meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization, SAGE noted with concern the impact of reluctance to accept immunization on the uptake of vaccines reported from both developed and developing countries. These reports led SAGE to request the establishment of a working group on vaccine hesitancy. Vaccine hesitancy refers to delay in acceptance or refusal of vaccines despite availability of vaccination services. Vaccine hesitancy is complex and context specific varying across time, place and vaccines. It includes factors such as complacency, convenience and confidence. (WHO SAGE Vaccine Hesitancy Working Group report)
  8. This page is aimed at providing a listing of existing vaccinology training courses, of varying durations and training modalities (in-person, online, blended), and an easy search process for interested parties looking for a vaccinology course and identifying alternative courses. The information provided on each course at the respective links is the sole responsibility of the persons in charge of their respective websites/courses. The listing of a vaccinology course on this page does not mean an endorsement of its content or any certification of the quality of the teaching approach. All training courses listed on this website have obtained formal endorsement/accreditation from either a tertiary training institution and/ or a training accreditation institution (e.g. Continued medical education). All courses listed, while varying in nature and prerequisites, tend to be advanced courses covering multiple aspects of vaccinology, if not alluding to all aspects. More courses may be available such as national courses targeting health workers or courses of a more focused nature such as courses on vaccine safety.
  9. For most readers of “Vaccine,” it is a truism that vaccines represent one of the safest and most effective tools available in global efforts to control and prevent infectious diseases. Yet, parents searching the Internet about whether or not it is safe to get themselves or their children vaccinated will find this consensus recast as a controversy, or even a conspiracy. Many of the top internet search results question or dispute the scientific consensus about the safety and effectiveness of some or all vaccine son a number of grounds, from secular to religious to political-philosophical. The gap between expert consensus and the thinking among many publics around the world is not limited to the Internet.The proliferation of conflicting information and the ease with which misinformation can amplify — via old and new media channels —provide a confusing context for parents seeking additional guidance from health workers, religious leaders, family members, or other trusted sources, many of whom may themselves be misinformed about the risks and benefits of vaccines. In this context, perhaps it is not surprising that some caregivers have become “hesitant” about decisions to vaccinate.
  10. The SAGE Working Group on Vaccine Hesitancy concluded that vaccine hesitancy refers to delay in acceptance or refusal of vaccination despite availability of vaccination services. Vaccine hesitancy is complex and context specific, varying across time, place and vaccines. It is influenced by factors such as complacency, convenience and confidence. The Working Group retained the term ‘vaccine’ rather than ‘vaccination’ hesitancy,although the latter more correctly implies the broader range of immunization concerns, as vaccine hesitancy is the more commonly used term. While high levels of hesitancy lead to low vaccine demand,low levels of hesitancy do not necessarily mean high vaccine demand. The Vaccine Hesitancy Determinants Matrix displays the factors influencing the behavioral decision to accept, delay or reject some or all vaccines under three categories: contextual, individual and group, and vaccine/vaccination-specific influences.
  11. Despite relatively high vaccination coverage rates in the European Region, vaccine hesitancy is under-mining individual and community protection from vaccine preventable diseases. At the request of its European Technical Advisory Group of Experts on Immunization (ETAGE), the Vaccine-preventable Dis-eases and Immunization Programme of the WHO Regional Office for Europe (WHO/EURO) developed tools to help countries address hesitancy more effectively. The Guide to Tailoring Immunization Programmes (TIP), an evidence and theory based behavioral insight framework, issued in 2013, provides tools to (1)identify vaccine hesitant population subgroups, (2) diagnose their demand- and supply-side immunization barriers and enablers and (3) design evidence-informed responses to hesitancy appropriate to the subgroup setting, context and vaccine. The Strategic Advisory Group of Experts on Immunization (SAGE)through its Working Group on Vaccine Hesitancy has closely followed the development, implementation,use and evolution of TIP concluding that TIP, with local adaptation, could be a valuable tool for use in all WHO regions, to help address countries’ vaccine hesitancy problems. The TIP principles are applicable to communicable, noncommunicable and emergency planning where behavioral decisions influence outcomes.
  12. When faced with vaccine hesitancy, public health authorities are looking for effective strategies to address this issue. In this paper, the findings of 15 published literature reviews or meta-analysis that have examined the effectiveness of different interventions to reduce vaccine hesitancy and/or to enhance vaccine acceptance are presented and discussed. From the literature, there is no strong evidence to recommend any specific intervention to address vaccine hesitancy/refusal. The reviewed studies included interventions with diverse content and approaches that were implemented in different settings and targeted various populations. Few interventions were directly targeted to vaccine hesitant individuals. Given the paucity of information on effective strategies to address vaccine hesitancy, when interventions are implemented, planning a rigorous evaluation of their impact on vaccine hesitancy/vaccine acceptance will be essential
  13. While most people vaccinate according to the recommended schedule, this success is challenged by individuals and groups who delay or refuse vaccines. The aim of this article is to review studies on vaccine hesitancy among healthcare providers (HCPs), and the influences of their own vaccine confidence and vaccination behaviour on their vaccination recommendations to others. The search strategy was developed in Medline and then adapted across several multidisciplinary mainstream databases including Embase Classic & Embase, and PschInfo. All foreign language articles were included if the abstract was available in English. A total of 185 articles were included in the literature review. 66% studied the vaccine hesitancy among HCPs, 17% analysed concerns, attitudes and/or behaviour of HCPs towards vaccinating others, and 9% were about evaluating intervention(s). Overall, knowledge about particular vaccines, their efficacy and safety, helped to build HCPs own confidence in vaccines and their willingness to recommend vaccines to others. The importance of societal endorsement and support from colleagues was also reported. In the face of emerging vaccine hesitancy, HCPs still remain the most trusted advisor and influencer of vaccination decisions. The capacity and confidence of HCPs, though, are stretched as they are faced with time constraints, increased workload and limited resources, and often have inadequate information or training support to address parents’ questions. Overall, HCPs need more support to manage the quickly evolving vaccine environment as well as changing public, especially those who are reluctant or refuse vaccination. Some recommended strategies included strengthening trust between HCPs, health authorities and policymakers, through more shared involvement in the establishment of vaccine recommendations.
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