How to improve communication on vaccine safety at international level?
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Biomedical subjects
Publications and source records attributed to P Duclos.
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Ever since vaccines were firstly used against smallpox, adverse events following immunization have been reported. As immunization programmes expand to reach even the most remote communities in the poorest countries, it is likely that many more events will be temporally linked with vaccine administration. Furthermore, the profound shift in the general public and media interest in adverse events may lead to undue concerns and allegations which may ultimately jeopardize immunization programmes world-wide. While the health professional has understood this issue for some time, the public and the media have now also become all too aware of the significance of vaccine-related adverse events. The familiar vaccines, well-tested over decades, have not changed--but the perception regarding their safety has shifted. Claims outrageous or reasonable are being made against both the old and the newly-introduced vaccines. At the same time, the immunological and genetic revolution of the last decade may well bring to our notice some hypothetical risks that need to be addressed at pre-clinical level. WHO has been at the leading edge to guarantee vaccine safety for the last 30 years and will continue to do so. The Organization's plans for the next decade and beyond include the Safe Injection Global Network (SIGN), the development and introduction of safer technologies, and the prevention, early detection and management of AEFIs. The new technologies include needle-containing injection devices such as the autodisable syringe, as well as mucosal and transcutaneous immunization. Training will continue to be at the centre of WHO's efforts, limiting human error to a minimum. Mechanisms have been set in place to detect and respond to new and unforeseen events occurring. Above all, there is a willingness to respond to new climates and new technologies so that the Organization is in the best position to ensure safe immunization for all the world's children.
In 1999, the World Health Organization (WHO) Department of Vaccines and Biologicals launched the Immunisation Safety Priority Project to boost its activities in this area, with the aim of establishing a comprehensive system to ensure the safety of all immunisations given in national immunisation programmes. Countries are the primary focus of this project. The WHO has a role to play not only because of its technical and normative role but also because of its privileged relationship with country authorities and other partners, its global vision and mandate, and because it is perceived as free from conflicts of interest. There are four areas of focus in the project: quality control and assessment tools to ensure vaccine safety from clinical trials up to and including the point of use;research and development of safer and simpler delivery systems; access to safer and more efficient systems for vaccine delivery and sharps waste management; and mechanisms to respond promptly and effectively to vaccine safety concerns. The project emphasises the importance of advocating safety and developing necessary infrastructure and human resource to properly deal with immunisation related safety issues at a national level.
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BACKGROUND: Varicella vaccine was approved for use in Canada in 1998. A major goal of universal varicella vaccine programs is to reduce severe infection and associated complications. Baseline data are essential against which to judge the effectiveness of routine childhood immunization. OBJECTIVE: To describe morbidity and mortality among children hospitalized for chickenpox. Methods. From January 1, 1991, to March 31, 1996, chickenpox admissions to 11 pediatric referral centers were actively identified. Patient and illness characteristics were compared for 3 subgroups defined by prior health: healthy; unhealthy but immunocompetent; immunocompromised. RESULTS: Of 861 cases 488 (56.7%) were healthy, 75(8.7%) were unhealthy and 298 (34.6%) were immunocompromised. The immunocompromised children differed from healthy/unhealthy cases in mean age (6.4 vs. 4.0/4.6 years, respectively, P < 0.0001); median interval from rash onset to admission (2 vs. 5/5 days, P < 0.0001); complication rate (20% vs. 90%/79%; P = 0.001); and rate of acyclovir therapy (98% vs. 24%/39%; P = 0.001). Unhealthy vs. healthy cases had a higher frequency (P < 0.01) of intensive care (13.3% vs. 4.7%), ventilation (9.3% vs. 2.0%) and death (4% vs. 0.2%). CONCLUSION: These data provide a baseline for morbidity/mortality resulting from chickenpox before varicella vaccine use in Canada.
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Although vaccines are among the safest of pharmaceuticals, the occasional severe adverse event or cluster of adverse events associated with their use may rapidly become a serious threat to public health. It is essential that national monitoring and reporting systems for vaccine safety are efficient and adequately coordinated with those that conventionally deal with non-vaccine pharmaceuticals. Equally important is the need for an enlightened and informed national system to be in place to deal with public concerns and rapid evaluation of the risk to public safety when adverse events occur. Described in this article is the outcome of efforts by the WHO Global Training Network to describe a simple national system for dealing with vaccine safety and with emergencies as they arise. The goals of a training programme designed to help develop such a system are also outlined.
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We evaluated if a single dose of a protective whole cell pertussis vaccine given before school entry to children primed with a less effective vaccine would increase their protection. A school cohort including 3876 students and a family cohort including 162 children were assessed. Although there was a trend toward increased protection. the better vaccine did not provide a significant improvement. These results suggest that a single dose of an effective vaccine given to children primed with a less effective one does not raise the protection to at level similar to that provided by three doses of the better vaccine.
To assess the morbidity associated with the continued high levels of pertussis, we studied all children <2 years of age who were admitted to the 11 Immunization Monitoring Program--Active (IMPACT) centers, which constitute 85% of Canada's tertiary care pediatric beds. In the 7 years preceding implementation of acellular pertussis vaccine, a total of 1,082 pertussis cases were reported, of which 49.1% were culture-confirmed. The median age of the patients was 12.4 weeks; 78.9% of cases were in children <6 months of age. Complications of pertussis were common: pneumonia was reported in 9.4% of cases, new seizures in 2.3%, and encephalopathy in 0.5%. There were 10 deaths (0.9%), all in children < or =6 months of age. Duration of hospitalization was longer (9.3 days vs. 4.9 days; P = .001) and intensive care was required more frequently (19.2% vs. 4.9%; P = .001) in infants under <6 months of age than in those > or =6 months. Pertussis continues to cause significant morbidity and occasional mortality in Canada, particularly in young infants.
BACKGROUND: Despite the implementation of mass school catch-up campaigns for measles in Canada, an outbreak of measles occurred in early 1997 mostly affecting the adult population. The higher incidence in Canada in adults led us to compare immunization policies and the evolution of measles among adults in Canada and the US. METHODS: Based on information gathered from both national immunization programmes and surveillance systems. RESULTS: Although the proportion of cases occurring in adults has increased tremendously in both countries in the past decade, there was no increase in measles incidence in these populations. The most likely factors to explain the higher rate of measles occurring in adults in Canada are the younger age at administration of first dose in Canada, the delay in implementation of a second dose policy in Canada compared with the US combined with the lack of prematriculation immunization requirements in Canadian colleges and universities, and the higher rate of overseas travel to and from Canada. The situation in Canada may also have been exacerbated by incomplete efforts to control measles for many years without attempting to eliminate the disease. CONCLUSIONS: In order to prevent measles in adults, high-risk groups must be identified and catch-up for selected groups considered. Vaccination of international travellers to endemic areas should be recommended until global elimination has been achieved. Appropriate measles control strategies in younger populations seem to be effective in preventing measles in adults. The experience in Canada and the US suggests that measles transmission in adults is unlikely to be a major impediment to regional elimination or global eradication.
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A range of vaccination policy options for improving the control of measles in Canada is investigated using a mathematical model to simulate transmission of the disease. Results suggest that a catch up campaign giving a second dose of vaccine to children aged up to 18 years would have an immediate impact on transmission, which could be maintained by the introduction of a routine second dose at either 18 months or 5 years of age. Introducing a routine second dose of vaccine without a catch up campaign would allow continued endemic transmission of measles among older children for at least 10-15 years.
A great deal of controversy has recently been generated over the publication of several articles implicating measles vaccine in the induction of Crohn's disease and autism. The publication of this work has already had a negative impact on measles vaccine acceptance in the UK. These allegations are particularly troubling because they arise in the context of increased use of measles vaccine as global control of measles nears and the international community considers strategies for a drive towards eradication. In 1994, the US Institute of Medicine reviewed the world literature and published a comprehensive review of adverse events associated with measles-containing vaccines. Reviewing the literature published between 1994 and the present day, reveals that there is considerable new data suggesting that modified gelatin rather than egg proteins is responsible for most episodes of anaphylaxis following measles vaccination. New work weakens the possible links between measles vaccine and subacute sclerosing panencephalitis and Guillain-Barré syndrome, but strengthens the rare association of measles-containing vaccines with post infectious encephalomyelitis. The alleged associations between measles vaccination and Crohn's disease and autism are based upon weak science and have largely been refuted by a large volume of stronger work. A review of the data generated in the last 4 years amply demonstrates the continued efforts of the scientific community to monitor and understand true measles vaccine-associated adverse events. The rapidity and clarity of this same community's debunking of the spurious associations with Crohn's disease and autism suggests that those charged with vaccination programmes have learned from past mistakes. During 30 years of worldwide use, measles vaccination has proven to be one of the safest and most successful health interventions in the history of mankind. It is not a 'perfect' vaccine, but the benefits of measles vaccination far outweigh the risks even in countries with low incidence of measles and high rates of measles vaccine coverage.
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The purpose of the study was to assess vaccination coverage of 2-year-olds and estimate immunization practices in Canada using a postal survey with a panel of 862 households. RIM weighting was used to provide national estimates. 95% CIs were calculated using the binomial method. Completed questionnaires were received for 534 children born between February 1991 and January 1992. Thirty nine percent of children had received all/most of their vaccinations at a public health clinic. Overall 5.6% parents indicated they had their child immunized because it was mandatory and 7.4% because of requirements for school, pre-school, nursery or day care attendance. A total of 78.7% of parents remembered receiving information on benefits of immunizations and 97% on the risks/side-effects. By their second birthday, 83.7% (95% CI 80.3-86.7) of 2-year-olds had received complete immunization against poliomyelitis; 97.2% (95% CI 95.4-98.4), at least one dose of a measles containing vaccine; 86.5% (95% CI 83.3-89.3), at least one dose of Haemophilus influenzae type b vaccine; and 81.6% (95% CI 78.1-84.8), at least, four doses of diphtheria, tetanus and pertussis vaccine.
Pertussis has re-emerged as a public health problem in Canada in recent years, emphasizing concerns about the effectiveness of the currently licensed whole-cell vaccine. Following a 1994 outbreak in Nova Scotia, we conducted a case-control study of 483 children aged < 10 years to assess vaccine effectiveness. Ninety-three percent of children aged 6 months and above had received three or more doses of vaccine, however, only 78% had received age-appropriate immunization. Among children aged 4 years and more, vaccine effectiveness against laboratory-confirmed pertussis was 57% (95% CI, 23-77%) for age-appropriate immunization (five doses) vs partial or no immunization. Vaccine effectiveness increased with increasing number of doses from 25% (95% CI, -58-65%) for three or more doses to 55% (95% CI, -15-83%) for five doses, compared with 0-2 doses.