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Background Vaccine regulation in China meets World Health Organization standards, but China’s vaccine industry and immunization program have some characteristics that differ from other countries. We described the history, classification, supply and prices of vaccines available and used in China, compared with high-and middle-incomes countries to illustrate the development of Chinese vaccine industry and immunization program. Methods Immunization policy documents were obtained from the State Council and the National Health and Family Planning Commission (NHFPC). Numbers of doses of vaccines released in China were obtained from the Biologicals Lot Release Program of the National Institutes for Food and Drug Control (NIFDC). Vaccine prices were obtained from Chinese Central Government Procurement (CCGP). International data were collected from US CDC, Public Health England, European CDC, WHO, and UNICEF. Results Between 2007 and 2015, the annual supply of vaccines in China ranged between 666 million and 1,190 million doses, with most doses produced domestically. The government’s Expanded Program on Immunization (EPI) prevents 12 vaccine preventable diseases (VPD) through routine immunization. China produces vaccines that are in common use globally; however, the number of routinely-prevented diseases is fewer than in high- and middle-income countries. Contract prices for program (EPI) vaccines ranged from 0.1 to 5.7 US dollars per dose - similar to UNICEF prices. Contract prices for private-market vaccines ranged from 2.4 to 102.9 US dollars per dose - often higher than prices for comparable US, European, and UNICEF vaccines. Conclusion China is a well-regulated producer of vaccines, but some vaccines that are important globally are not included in China’s EPI system in China. Sustained and coordinated effort will be required to bring Chinese vaccine industry and EPI into an era of global leadership.

Using data from digitized weekly surveillance reports of notifiable diseases for U.S. cities and states for 1888 through 2011, the authors derived a quantitative history of disease reduction in the United States, focusing particularly on the effects of vaccination programs. Public health programs — especially vaccination programs — have led to dramatic declines in the incidence of contagious diseases in the United States over the past century. 1 – 3 However, some contagious diseases are now on the rise despite the availability of vaccines. Pertussis vaccines have been available since the 1920s, but the worst pertussis epidemic since 1959 occurred in 2012, with more than 38,000 cases nationwide reported by last December. 4 , 5 Outbreaks of measles also continue to occur, even though a measles vaccine has been licensed in the United States since 1963. 6 The current low overall incidence of contagious diseases . . .

The challenges faced in delivering lifesaving vaccines to the targeted beneficiaries need to be addressed from the existing knowledge and learning from the past. This review documents the history of vaccines and vaccination in India with an objective to derive lessons for policy direction to expand the benefits of vaccination in the country. A brief historical perspective on smallpox disease and preventive efforts since antiquity is followed by an overview of 19 th century efforts to replace variolation by vaccination, setting up of a few vaccine institutes, cholera vaccine trial and the discovery of plague vaccine. The early twentieth century witnessed the challenges in expansion of smallpox vaccination, typhoid vaccine trial in Indian army personnel, and setting up of vaccine institutes in almost each of the then Indian States. In the post-independence period, the BCG vaccine laboratory and other national institutes were established; a number of private vaccine manufacturers came up, besides the continuation of smallpox eradication effort till the country became smallpox free in 1977. The Expanded Programme of Immunization (EPI) (1978) and then Universal Immunization Programme (UIP) (1985) were launched in India. The intervening events since UIP till India being declared non-endemic for poliomyelitis in 2012 have been described. Though the preventive efforts from diseases were practiced in India, the reluctance, opposition and a slow acceptance of vaccination have been the characteristic of vaccination history in the country. The operational challenges keep the coverage inequitable in the country. The lessons from the past events have been analysed and interpreted to guide immunization efforts.

In the 20th century, childhood mortality decreased rapidly, and vaccination programmes are frequently suggested as a contributing factor. However, quantification of this contribution is subject to debate or absent. We present historical data from the Netherlands that allow us to quantify the reduction in childhood mortality burden for vaccine-preventable diseases in this period as a function of vaccination coverage. We retrieved cause-specific and age-specific historical mortality data from Statistics Netherlands from 1903 to 2012 (for Dutch birth cohorts born from 1903 to 1992), and data for vaccination coverage since the start of vaccination programmes from the Dutch Health Care Inspectorate and the Dutch National Institute for Public Health and the Environment. We also obtained birth and migration data from Statistics Netherlands. We used a restricted mean life-time method to estimate cause-specific mortality burden among children and young adults for each birth cohort as the years of life lost up to age 20 years, excluding migration as a variable because this did not affect the results. To correct for long-term trends, we calculated the cause-specific contribution to the total childhood mortality burden. In the prevaccination era, the contribution to mortality burden was fairly constant for diphtheria (1·4%), pertussis (3·8%), and tetanus (0·1%). Around the start of mass vaccinations, these contributions to the mortality burden decreased rapidly to near zero. We noted similar patterns for poliomyelitis, mumps, and rubella. The number of deaths due to measles around the start of vaccination in the Netherlands were too few to detect an accelerated rate of decrease after mass vaccinations were started. We estimate that mass vaccination programmes averted 148 000 years of life lost up to age 20 years (95% prediction interval 110 000–201 000) among children born before 1992. This corresponds to about 9000 deaths averted (6000–12 000). Our historical time series analysis of mortality and vaccination coverage shows a strong association between increasing vaccination coverage and diminishing contribution of vaccine-preventable diseases to overall mortality. This analysis provides further evidence that mass vaccination programmes contributed to lowering childhood mortality burden. Dutch Ministry of Health, Welfare and Sport.

•Increased concern about vaccines’ safety led to reduction in vaccine coverage.•Universal vaccination programs effective but historical impacts not often evaluated.•In Italy more than 4 million cases of 10 vaccine-preventable diseases were prevented.•Data analysis strongly supports the value of the universal vaccination programs.•Vaccination programs should be strengthened to maintain high vaccine coverage. Vaccination has determined a dramatic decline in morbidity and mortality from infectious diseases over the last century. However, low perceived risk of the infectious threat and increased concern about vaccines’ safety led to a reduction in vaccine coverage, with increased risk of disease outbreaks. Annual surveillance data of nationally communicable infectious diseases in Italy between 1900 and 2015 were used to derive trends in morbidity and mortality rates before and after vaccine introduction, focusing particularly on the effect of vaccination programs. Autoregressive integrated moving average models were applied to ten vaccine-preventable diseases: diphtheria, tetanus, poliomyelitis, hepatitis B, pertussis, measles, mumps, rubella, chickenpox, and invasive meningococcal disease. Results of these models referring to data before the immunization programs were projected on the vaccination period to estimate expected cases. The difference between observed and projected cases provided estimates of cases avoided by vaccination. The temporal trend for each disease started with high incidence rates, followed by a period of persisting reduction. After vaccine introduction, and particularly after the recommendation for universal use among children, the current rates were much lower than those forecasted without vaccination, both in the whole population and among the 0-to-4 year olds, which is, generally, the most susceptible age class. Assuming that the difference between incidence rates before and after vaccination programs was attributable only to vaccine, more than 4 million cases were prevented, and nearly 35% of them among children in the early years of life. Diphtheria was the disease with the highest number of prevented cases, followed by mumps, chickenpox and measles. Universal vaccination programs represent the most effective prevention tool against infectious diseases, having a major impact on human health. Health authorities should make any effort to strengthen public confidence in vaccines, highlighting scientific evidence of vaccination benefits.

In the annals of public health, smallpox is a watershed, being the first disease eradicated by vaccination. Drawing parallels to contemporary pandemic control measures, we examined the first smallpox vaccination campaigns in early 19th-century northern Italy and the seminal work of Luigi Sacco. Our study delves into this under-explored historical landscape to elucidate lessons that resonate with modern public health dilemmas. We scrutinised primary sources from the Historical Civic Archive of Pavia, the State Archive of Pavia, and the State Archive of Milan. These archives provided exhaustive data on administrative decrees, local epidemiology, and university-health authority collaborations. Using period-specific keyword searches and expert consultations, we extensively reviewed correspondence, vaccination lists, and academic writings, including Luigi Sacco's seminal Trattato di vaccinazione. The epidemiological investigation focused on the pivotal period of 1816–1828 in Lombardy's 19th-century public health landscape. Organisational reforms enacted in 1821 succeeded in doubling the number of vaccinations administered in Pavia, stabilising at elevated rates in subsequent years. Despite improvements, incongruities in epidemiological data and vaccinator remuneration persisted. Communication strategies pioneered by Sacco, encompassing academic and religious collaborations, demonstrated their efficacy. Epidemiological data revealed an initial surge in vaccination uptake in 1822, with a declining trend in the following years, notably impacted by logistical and data recording limitations. Our research underscores three salient dimensions pertinent to contemporary public health paradigms: first, the vital function of local administrative bodies as efficacious service providers, immunisation register keepers, and social safety nets; second, the equilibrium between mandatory vaccination policies and discretionary enforcement as a pragmatic framework for public compliance; lastly, the irrefutable importance of credible communication strategies in fighting vaccine hesitancy. These insights are not merely historical curiosities but cardinal principles for effectively managing modern epidemics and infectious disease threats. •Luigi Sacco was a pioneer in European smallpox vaccination in early 1800s Lombardy.•Historical analysis reveals similarities in vaccine campaign challenges then and now.•Local district organisation was the key to early widespread vaccine coverage.•Epidemiological data collection was a cornerstone for vaccination success.•Modern communication approaches and flexible mandates were crucial historically.

China's immunization program is one of the oldest and largest in the world. Rates of vaccine-preventable diseases (VPD) are comparable to those in high-income countries. The program's evolution has been characterized by ambitious target setting and innovative strategies that have not been widely described. We reviewed national and provincial health department archives; analyzed disease surveillance, vaccination coverage, and serosurvey data from 1950 through 2016; and, conducted in-depth interviews with senior Chinese experts involved early VPD control efforts. Widespread immunization began in the 1950s with smallpox, diphtheria, and Bacillus-Calmette Guerin vaccines, and in the 1960s with pertussis, tetanus, polio, measles, and Japanese encephalitis (JE) vaccines. The largest drops in absolute VPD burden occurred in the 1970s with establishment of the Rural Cooperative Medical System and a cadre of trained peasant health workers whose responsibilities included vaccinations. From 1970 to 1979, incidence per 100,000 population dropped 48% from 3.3 to 1.75 for diphtheria, 50% from 152.2 to 49.4 for pertussis, 77% from 2.5 to 0.6 for polio, 60% from 450.5 to 178.3 for measles, and 72% from 18.0 to 5.1 for JE, averting an average of 4 million VPD cases each year. Until the early 1980s, vaccines were delivered through annual winter campaigns using a coordinated ‘rush-relay’ system to expedite transport while leveraging vaccine thermostability. Establishment of the cold chain system during in the 1980s allowed bi-monthly vaccination rounds and more timely vaccination resulting in rates of diphtheria, pertussis, measles and meningitis falling over 90% from 1980 to 1989, while polio and JE rates fell 40–50%. In the 1990s, progress stalled as financing for public health was weakened by broad market reforms. Large investments in public health and immunizations by the central government since 2004 has led to further declines in VPD burden and increased equity. During 2011–2016, the incidence per 100,000 population was <2.0 for measles and <0.2 for pertussis, JE, meningococcal meningitis, and hepatitis A. From 1992 to 2014, the prevalence of chronic hepatitis B infection in children <5 years fell from 9.7% to 0.3%, a 97% decline. China was certified polio-free in 2000 and diphtheria was last reported in 2006. Long-term political commitment to immunizations as a basic right, ambitious targets, use of disease incidence as the primary metric to assess program performance, and nationwide scale-up of successful locally developed strategies that optimized use of available limited resources have been critical to China's success in controlling vaccine-preventable diseases.

•Describes the 25 years of evolution of the vaccines prequalification programme at WHO.•Provides rationale for changes introduced.•Provides information on the service provided and its impact.•Discusses possible future directions of the programme. The World Health Organization (WHO) vaccines prequalification programme was established in 1987. It is a service provided to United Nations procurement agencies to ensure that the vaccines supplied through these agencies are consistently safe and effective under conditions of use in national immunization programmes. This review describes the purpose and aims of the programme, its evolution during 25 years of existence, its added value, and its role in the context of the WHO strategy to ensure the global availability of vaccines of assured quality. The rationale for changes introduced during the implementation of the programme is provided. The paper also discusses the resources involved, both human and financial, its performance, strengths and weaknesses and steps taken to maximize its efficiency. This historical perspective is used to inform proposed future changes to the service.

The term “global health” is rapidly replacing the older terminology of “international health.” We describe the role of the World Health Organization (WHO) in both international and global health and in the transition from one to the other. We suggest that the term “global health” emerged as part of larger political and historical processes, in which WHO found its dominant role challenged and began to reposition itself within a shifting set of power alliances. Between 1948 and 1998, WHO moved from being the unquestioned leader of international health to being an organization in crisis, facing budget shortfalls and diminished status, especially given the growing influence of new and powerful players. We argue that WHO began to refashion itself as the coordinator, strategic planner, and leader of global health initiatives as a strategy of survival in response to this transformed international political context.

In 1813, the American government passed An Act to Encourage Vaccination, the first federal endorsement of a medical practice in American history. The law tasked a federal agent with maintaining a supply of the smallpox vaccine and distributing it nationwide. James Smith, a well-respected physician and proponent of vaccination, was appointed as vaccine agent. Smith was skeptical of claims that only well-trained physicians should be allowed to perform vaccination; he felt it was a simple procedure that should be available to all American citizens. In 1822, he made a tragic error that caused several deaths and left him vulnerable to criticism from political opponents and his medical peers. This ended Smith’s professional career and led to the repeal of the act itself. In this article, we use the rise and fall of James Smith to provide a historical perspective on contemporary debates surrounding delayed vaccination schedules. We explain how physicians—in the 19th century and today—have worked to build public trust in vaccination in an American culture suspicious of medical expertise.