The life-course approach to vaccination: Harnessing the benefits of vaccination throughout life.

Vaccination beyond childhood brings significant benefits at the individual, community and socio-economic levels. Despite this, immunisation programmes often fail to deliver the vaccines which could protect those at risk of vaccine-preventable diseases. In this commentary, we argue that the benefits of vaccination beyond childhood must be more widely understood and furthermore, that action must be taken by policymakers, healthcare professionals and patient and civil society organisations to ensure that the benefits of vaccination are fully realised. We outline five areas where change is needed to ensure vaccination across the life-course becomes truly embedded in national immunisation programmes. This includes investing in robust data collection and analysis; ensuring coordinated, multidisciplinary leadership from the top; engaging healthcare professionals; changing public perceptions of vaccination; and integrating vaccination into schools and workplaces.

Maternal immunization: A call to accelerate progress.

Maternal immunization provides an excellent evidence-based strategy for preventing severe disease and decreasing neonatal and infant mortality. A substantial proportion of these deaths are due to infectious diseases, most of them vaccine-preventable, then, there is a real opportunity for intervention. Maternal immunization has been an underexploited area for many years, with the exception of neonatal tetanus. There are now programs for influenza and acellular pertussis vaccination in many countries and two maternal vaccine targets under development are focused on decreasing the burden of infant respiratory syncytial virus (RSV) and Group B Streptococcus (GBS). Bodies like the Strategic Advisory Group of Experts (SAGE) on Immunization established by the WHO, the Global Vaccine Action Plan (GVAP) and Gavi, The Vaccine Alliance, have recognized the relevance of maternal immunization on several occasions. However, why is the field not moving faster, as one might expect? Major initiatives and programs should consider spelling out more clearly the role and benefits of this intervention and calling for specific actions, including future strategic approaches for the post 2020 immunization strategy following the GVAP; and single out the area as one of its priorities as a key component of immunization across the life course. While waiting for the new vaccines like RSV and GBS and optimizing the use of influenza and pertussis there is momentum now to coordinate efforts, address the missing information and action gaps, and call to accelerate progress.

Effectively introducing a new meningococcal A conjugate vaccine in Africa: the Burkina Faso experience.

A new Group A meningococcal (Men A) conjugate vaccine, MenAfriVac™, was prequalified by the World Health Organization (WHO) in June 2010. Because Burkina Faso has repeatedly suffered meningitis epidemics due to Group A Neisseria meningitidis special efforts were made to conduct a country-wide campaign with the new vaccine in late 2010 and before the onset of the next epidemic meningococcal disease season beginning in January 2011. In the ensuing five months (July-November 2010) the following challenges were successfully managed: (1) doing a large safety study and registering the new vaccine in Burkina Faso; (2) developing a comprehensive communication plan; (3) strengthening the surveillance system with particular attention to improving the capacity for real-time polymerase chain reaction (PCR) testing of spinal fluid specimens; (4) improving cold chain capacity and waste disposal; (5) developing and funding a sound campaign strategy; and (6) ensuring effective collaboration across all partners. Each of these issues required specific strategies that were managed through a WHO-led consortium that included all major partners (Ministry of Health/Burkina Faso, Serum Institute of India Ltd., UNICEF, Global Alliance for Vaccines and Immunization, Meningitis Vaccine Project, CDC/Atlanta, and the Norwegian Institute of Public Health/Oslo). Biweekly teleconferences that were led by WHO ensured that problems were identified in a timely fashion. The new meningococcal A conjugate vaccine was introduced on December 6, 2010, in a national ceremony led by His Excellency Blaise Compaore, the President of Burkina Faso. The ensuing 10-day national campaign was hugely successful, and over 11.4 million Burkinabes between the ages of 1 and 29 years (100% of target population) were vaccinated. African national immunization programs are capable of achieving very high coverage for a vaccine desired by the public, introduced in a well-organized campaign, and supported at the highest political level. The Burkina Faso success augurs well for further rollout of the Men A conjugate vaccine in meningitis belt countries.

Rotavirus vaccines for infants in developing countries in Africa and Asia: considerations from a world health organization-sponsored consultation.

The World Health Organization (WHO) and its international partners have prioritized the development of rotavirus vaccines for the past 3 decades. In November 2005, the WHO's Strategic Advisory Group of Experts first reviewed the clinical efficacy data from 2 new live attenuated oral rotavirus vaccines, which demonstrated excellent protective efficacy against severe rotavirus disease in regions where they were evaluated. Despite these successes, the WHO has urged the clinical evaluation of these vaccines in populations of Africa and Asia, where most of the deaths due to rotavirus occur, and has emphasized the need for ongoing postlicensure safety monitoring in countries introducing vaccines. Clinical studies in Africa and Asia will soon provide data on the efficacy of both new vaccines in these populations. A WHO international consultative meeting convened to evaluate how to use these imminent data for the future use of rotavirus vaccines in developing countries. In brief, it was agreed that (1) even vaccines with lesser efficacy in developing countries, compared with industrialized countries, would still lead to substantial public health benefits and would be cost-effective in saving lives in Africa and Asia; (2) criteria, such as the WHO mortality strata and local epidemiology of rotavirus infection, would be appropriate measures for extrapolating the clinical data to other regions and countries; and (3) research toward understanding the programmatic limitations of rotavirus vaccine use may help develop strategies to improve vaccine uptake and overall impact.

Analysis of strategies to successfully vaccinate infants in developing countries against enterotoxigenic E. coli (ETEC) disease.

Enterotoxigenic Escherichia coli (ETEC) is the most common bacterial cause of diarrhoea in the world, annually affecting up to 400,000,000 children under 5 years of age living in developing countries (DCs). Although ETEC possesses numerous antigens, the relatively conserved colonization factor (CF) antigens and the heat labile enterotoxin (LT) have been associated with protection and most vaccine candidates have exploited these antigens. A safe and effective vaccine against ETEC is a feasible goal as supported by the acquisition of protective immunity. The success of an ETEC vaccine targeting infants and children in DCs will depend on a combination of maximally antigenic vaccine preparations and regimens for their delivery which will produce optimal immune responses to these antigens. Vaccine candidates having a high priority for accelerated development and clinical testing for eventual use in infants would include inactivated ETEC or Shigella hybrids expressing ETEC antigens as well as attenuated ETEC strains which express the major CF antigens and LT toxin B-subunit, as well as attenuated Shigella, Vibrio cholerae and Salmonella typhi hybrids engineered to deliver antigens of ETEC. Candidates for an ETEC vaccine would have to meet the minimal requirement of providing at least 50% protection against severe disease in DCs during the first 2 years of life. The critical roadblock to achieving this goal has not been the science as much as the lack of a sufficiently funded and focused effort to bring it to realization. However, a Product Development Partnership to overcome this hurdle could accelerate the time lines towards when control of ETEC disease in DCs is substantially closer.

Chapter 15: HPV vaccine use in the developing world.

Human papillomavirus (HPV)-related morbidity and mortality from cervical cancer primarily occurs in the developing world, where, unfortunately, access to vaccines in general, and expensive newer vaccines in particular, is often more limited than in the industrialized world. In addition, secondary prevention methods such as HPV screening, Pap testing, or visual inspection are uncommon in the developing world. The HPV vaccine will be first introduced into the industrialized countries and it will then, over the course of time, become used in the developing countries. HPV vaccine should be introduced in the framework of comprehensive cervical cancer control, and offers an opportunity to bring together a wide range of constituents who have not to date worked closely on vaccination. Ultimately, the decision of whether and when a vaccine will be introduced will depend on individual countries. To prepare for decisions on HPV vaccine use, the sexual and reproductive health (SRH; including adolescent health), immunization, and cancer control communities need to work together to analyze the appropriate data and build international and national consensus. The timeframe for other newer vaccines, such as hepatitis B and Hib, has been measured in decades, and the challenge to the public sector is to greatly shorten the time needed to make HPV vaccines available and affordable for the developing world, where their impact will be greatest.

Immunization safety priority project at the World Health Organization.

In 1999, the World Health Organization's (WHO) Department of Vaccines and Biologicals launched the Immunization Safety Priority Project with the aim of establishing a comprehensive system to ensure the safety of all immunizations given in national immunization programs. Countries are the primary focus of the project. WHO has a role, not only because of its technical and normative role, but also because of its privileged relationship with country authorities and other partners, and its global vision and mandate. The four major areas of focus in the project are to (1) promote and coordinate research and development of safer and simpler delivery systems; (2) ensure vaccine safety, from vaccine development all the way through clinical trials and vaccine distribution until use; (3) broaden access to safer and more efficient systems for vaccine delivery and management of sharps waste; and (4) establish efficient mechanisms to detect serious or potentially serious adverse events following immunization, and enable prompt and effective response. The project emphasizes the importance of advocating safety and building capacity at national levels.