GAVI, the Vaccine Alliance.

This year's Lasker-Bloomberg Public Service Award goes to GAVI, the Vaccine Alliance, for providing sustained access to childhood vaccines around the globe, saving millions of lives, and highlighting the power of immunization to prevent disease.

Early Poultry Vaccine Company Development: the Era of Entrepreneurs.

Early events leading to the establishment of various branches of the U.S. poultry industry and the animal health industry in the United States are reviewed. Entrepreneurs see needs in a developing market and take action to meet these needs. Their skills are suited to organize people and processes to supply these needs. As the early poultry industry consolidated, this was followed by technical education as a marketing tool to expand access to the customer base. Focus will be on two entrepreneurial individuals not well covered by prior history articles, namely Hiram Lasher and Kenneth Eskelund. A discussion of how industries pass from an entrepreneurial phase to a corporate phase will follow, thus explaining the corporate- and biotechnology-oriented vaccine companies we see today.

Artículo histórico - Desarrollo temprano de las compañías de vacunas avícolas: la era de los empresarios. Se revisaron los primeros eventos que llevaron al establecimiento de varias ramas de la industria avícola y de la industria de la salud animal en los Estados Unidos. Los empresarios detectaron las necesidades en un mercado en desarrollo y tomaron medidas para satisfacer dichas necesidades. Sus habilidades fueron adecuadas para organizar personas y procesos para satisfacer estas necesidades. A medida que se consolidó la industria avícola temprana, esto fue seguido por la educación técnica como una herramienta de mercadeo para ampliar el acceso a la base de clientes. La atención se centró en dos personas emprendedoras que no han sido adecuadamente analizadas por los artículos históricos anteriores como son, Hiram Lasher y Kenneth Eskelund. Se explicó cómo las industrias pasaron de una fase empresarial a una fase corporativa, explicando así las compañías de vacunas orientadas a la biotecnología y las empresas actuales.

Study on the Procedure for Lot Release of Vaccines in Japan.

Biological products, such as vaccines, blood products, antitoxins, and antivenoms, are released into the market following a lot release conducted by National Regulatory Authorities or National Control Laboratories, even if their manufacturing and marketing have been authorized. Independent lot release by regulatory authorities is not a procedure unique to Japan, but is performed worldwide. Previously, Japan carried out lot release mainly by laboratory tests, and the manufacturers' in-house test records were used as a reference, not involved in the decision of lot release. Conversely, the international standard procedure promoted by the World Health Organization (WHO) includes a document review of the manufacturers' summary protocols, and laboratory tests are listed as an optional procedure. To harmonize with the WHO recommended international method, Japan modified the procedure and introduced a document review in addition to laboratory tests for vaccines in 2012. Since then, substantial knowledge regarding vaccine quality has been obtained during the process of summary protocol reviewing. Here, we outline the current status of the lot release procedure in Japan. We shed light on its history and show recent research based on the knowledge obtained from the protocol review to improve efficiency of laboratory testing and international harmonization.

Thomas Wilson Groves.

Tom was a kind, gentle and knowledgeable man who lived a long and interesting life.

Adjudicating non-knowledge in the Omnibus Autism Proceedings.

After 5600 families of children diagnosed with autism filed claims with the National Vaccine Injury Compensation Program in the United States, the court selected 'test' cases consolidated into the Omnibus Autism Proceedings, held from 2007 to 2008, to examine claims that vaccines caused the development of autism. The court found all of the causation theories presented to be untenable and did not award damages to any parents. We analyze the Omnibus Autism Proceedings as a struggle within the scientific field between the scientific orthodoxy of the respondents and the heterodox position taken by the plaintiffs, suggesting that the ruling in these cases helped to shore up hegemony on autism causation. Drawing on the literature on non-knowledge, we suggest that only the respondents had enough scientific capital to strategically direct non-knowledge toward genetic research, thereby foreclosing the possibility of environmental causation of autism. The plaintiffs, who promote a non-standard ontology of autism, suggest that the science on autism remains undone and should not be circumscribed. In analyzing the Omnibus Autism Proceedings with field theory, we highlight the way in which scientific consensus-building and the setting of research agendas are the result of struggle, and we show that the strategic deployment of non-knowledge becomes a major stake in battles for scientific legitimacy and the settling of scientific controversies.

Chinese vaccine products go global: vaccine development and quality control.

Through the continuous efforts of several generations, China has become one of the few countries in the world that is capable of independently addressing all the requirements by the Expanded Program on Immunization. Regulatory science is applied to continuously improve the vaccine regulatory system. Passing the prequalification by WHO has allowed Chinese vaccine products to go global. Chinese vaccine products not only secure disease prevention and control domestically but also serve the needs for international public health. This article describes the history of Chinese vaccine development, the current situation of Chinese vaccine industry and its contribution to the prevention and control of infectious diseases. We also share our experience of national quality control and vaccine regulation during the past decades. China's experience in vaccine development and quality control can benefit other countries and regions worldwide, including the developing countries.

Prevention is better than cure.

The history of the control of infectious disease reflects the balance between our understanding of the nature of infection, the mechanisms of host resistance and the available technology to deliver an intervention. However, behind this 'biomedical' construct lies a deeper set of issues which embody serendipity, public understanding, and population-based intervention and its acceptability by the wider community, often complicated by the decisions and subsequent vacillations of policy makers.

The first pharmacoepidemiologic investigations: national drug safety policy in the United States, 1901-1902.

The pharmaceutical industry developed in the late 19th century as a consequence of both scientific and commercial innovations, such as the development of diphtheria antitoxin and the commercialization of smallpox vaccine. Two tetanus outbreaks in 1901 -- from contaminated diphtheria antitoxin in St. Louis, Missouri, and contaminated smallpox vaccine in Camden, New Jersey -- raised public concern about pharmaceutical safety. In St. Louis, errant manufacturing processes were found to be the source of the outbreak. In Camden, investigation identified contaminated vaccine from one manufacturer as the cause. These investigations, the first known pharmacoepidemiologic studies, were widely reported. They formed the basis for the 1902 Biologics Control Act, which focused on the safety of biologics produced and sold by the pharmaceutical industry and established a precedent of federal regulation of this industry. That power, welcomed by manufacturers to restore the public's trust in their products, was enhanced in the 1906 Food and Drug Act, which created the Food and Drug Administration.

Mercury, vaccines, and autism: one controversy, three histories.

The controversy regarding the once widely used mercury-containing preservative thimerosal in childhood vaccines has raised many historical questions that have not been adequately explored. Why was this preservative incorporated in the first place? Was there any real evidence that it caused harm? And how did thimerosal become linked in the public mind to the "autism epidemic"? I examine the origins of the thimerosal controversy and their legacy for the debate that has followed. More specifically, I explore the parallel histories of three factors that converged to create the crisis: vaccine preservatives, mercury poisoning, and autism. An understanding of this history provides important lessons for physicians and policymakers seeking to preserve the public's trust in the nation's vaccine system.

[Serums and vaccines to fight the 1918-1919 influenza pandemic in Spain]. / Sueros y vacunas en la lucha contra la pandemia de gripe de 1918-1919 en España.

Against the background of the renewed interest aroused in recent years by the influenza pandemic of 1918-1919, and the leading role now played by research analysing the process of innovation in medicine, this paper assesses the role played by serums and vaccines - the new resources of the medical science of the time 0 in the fight against the influenza outbreak of 1918-1919. The paper highlights the dependence on combined scientific, social, economic and professional factors, and also shows the main consequences arising from the fine-tuning and implementation of these therapeutic and prophylactic resources.