Session I—The Science and Control of Biologicals: Changes in Technology of Vaccine Research, Development, and Control (original) (raw)
Successes and failures: Worldwide vaccine development and application
Biologicals, 2010
The impact that vaccines have had on world health has been great. The misery prevented and the lives saved have been impressive. But all has not been good. As one looks at the success, one can also see the missed opportunities. This discussion takes a broad, worldwide view of vaccines -from early research, through development and application. It examines our successes and our failures and looks with great optimism towards a future having great potential to prevent much of today's suffering from infectious diseases.
Regulation and testing of vaccines
Vaccines, 2013
Measles virus vaccine, live 4 Measles, mumps, and rubella vaccine, live 4 Measles, mumps, rubella and varicella virus vaccine, live 4 Poliovirus vaccine inactivated, human diploid cell 2 † Poliovirus vaccine inactivated, monkey kidney cell 6 Rabies vaccine 3, 6 Rotavirus vaccine, live, oral 7 Rotavirus vaccine, live, oral, pentavalent 4 Rubella virus vaccine, live 4 Smallpox (vaccinia) vaccine, live 13 Varicella virus vaccine live 4 Yellow fever vaccine 1 Zoster vaccine, live 4
The development of the vaccine industry, 1800-present: a historical-sociological field approach
International Journal of Business and Globalisation, 2016
Since the 1990s the vaccine sector is experiencing a profound restructuring with the entrance of innovative biotech companies, developing country manufacturers, and wealthy private foundations. Since these developments and their consequences are rarely analysed in their interconnectedness, we argue, first, that a field approach focusing on the interrelations between the organisations in the vaccine sector is a fruitful way to unravel the complexities of the current changes. Second, a long-term historical-sociological analysis of this field is presented since the discovery of the smallpox vaccine around 1800. The current changes are interpreted as the third transformation of the field. After the shift from local to national vaccine fields, and then to an internationally coordinated field, the recent changes can be characterised as a shift to a more encompassing, diversified global field. These historical transformations can be explained by changing balances of power between the organisations with an interest in the field.
Lock in, the state and vaccine development: Lessons from the history of the polio vaccines
Research Policy, 2005
Over the past two decades pharmaceutical industry interest in the development of vaccines against infectious diseases has grown. At the same time various partnerships and mechanisms have been established in order to reconcile the interests of private industry with the needs of public health systems (especially in the developing world). The general assumption is that, lacking resources and competences, the public sector has little or no role to play in vaccine development. Drawing on the concept of 'lock in', and the history of vaccines against poliomyelitis, this paper advances a different set of considerations relevant to the role of the public sector. It was thanks to public sector R&D, driven by technical and public health considerations, not commercial ones, that a vaccine that had been virtually 'locked out' of the world markets was improved, and expertise in its production sustained. This vaccine now plays a crucial role in current attempts at eradicating polio. It is suggested that despite subsequent changes in vaccine technology, their different incentive structure requires acknowledgement in current discussion of the potential contribution of public sector vaccine institutes to vaccine innovation.
Challenges of Developing Novel Vaccines and Large Scale Production Issues
Journal of drug research and development, 2022
Live attenuated and inactivated pathogens, as well as subunit vaccinations, can give long-term protection against a variety of deadly diseases. Despite this progress, vaccine development for a number of infectious diseases, particularly those that are more capable of evading the adaptive immune response, remains a serious issue. Furthermore, the fundamental impediment to the greatest uptake of virus vaccines isn't usually the efficacy of conventional procedures, but rather the requirement for more fast research and large-scale manufacture. As a result, the development of more powerful and adaptable vaccine platforms is critical. The complexities of developing the manufacturing process, formulation, and analytical assays, as well as the problem of scientific assay optimization, are the most well-known barriers to vaccine development failures or delays. Scientists argue that the extremely concentrated state of global vaccine manufacturing capacity limits large-scale vaccine production. At the moment, only a few countries have the capacity to make vaccines on their own. Scaling up vaccine production is difficult, and a shortage of manufacturing sites is limiting global vaccine availability. Vaccine manufacturing and the development of breakthrough technologies capable of producing huge quantities of vaccines against known and undiscovered infections are difficult tasks nowadays. Vaccines can be made as suspensions, emulsions, or freeze-dried powders with a variety of adjuvants. However, many of those manufactured vaccines face multiple problems from a pharmaceutical standpoint, including the risk for acute hypersensitivity reactions, the need for extremely cold storage temperatures, and handling and delivery requirements. These requirements should limit vaccine supply to different populations, which has a negative impact on health equity. In the production of vaccines during upstream and downstream processes, new facilities, equipment, and enabling technology may be required, some of which may have an impact on how existing vaccines are manufactured. Despite these advancements, long-standing difficult circumstances will persist or worsen. Despite the fact that the number of individuals required is significantly less than in massive phase 3 studies, pharmacokinetic investigations can be logistically challenging and expensive. Even if there are challenging scenarios for implementing new pharmacokinetic models, there may be significant value in doing so, even in the context of an approved medication. The use of this ethically complex and contentious method for vaccine evaluation would necessitate interdisciplinary, global oversight to ensure that the results are rigorous and justify the potential dangers to participants and their communities.
The global vaccine enterprise : A developing world perspective
Nature Medicine, 1998
tion necessary to make plants efficient vaccine production systems. Many antigenic proteins from infectious viruses are chemically modified in host cells, for example, by the addition of sugars to produce glycoproteins. Although plants will glycosylate proteins, the carbohydrate additions are different from those of mammalian cells. This could be a hindrance in expression of certain immunogens if the sugar component of glycoproteins determines protective epitopes. Ongoing studies with a rabies virus glycoprotein produced in plants may answer this question 6 • Some vaccines require the presence of structural epitopes determined by protein folding and association. Notably, plants produce virus-like particles that mimic the structure of the authentic viral proteins 1 • 2 • 4 • In the case of hepatitis B surface antigen, the virus-like particles from plants preserve both the Band T-cell epitopes that are present in the currently available commercial vaccine 2 • Preclinical studies of plant-expressed bacterial antigens, LT-Band CT-B, have provided indirect evidence for protective immunity in mice. The animals produce antibodies that neutralize the native bacterial toxins in mammalian cell assays and in the fluid accumulated in the intestines of animals challenged with the bacterial toxin 3 • 5 • 8 , Based upon animal trials, the U.S. Food and Drug Administration approved human clinical testing of raw potatoes containing LT-Bin 1997. Theresultsofthistrial are described in the current issue of Nature
2022
The history of vaccines travels a long and winding road shaped by challenges, optimism, learning, and discoveries. Starting with early forms of immunization originating as early as the 17th century, to the modern science that made the COVID-19 vaccines available, this book explores the history of vaccines through detailed scientific research and meaningful illustrations. Some of the major personalities and events that shaped the field of vaccinology are recounted through a historical lens and complemented by visual flair. With increasingly refined technologies and developments in science, the story of vaccines continues to be written and the future remains undefined. However, one thing is certain: its potential to improve the lives of millions around the world makes vaccines indispensable to human health in the past, present, and future.
A brief history of vaccines and vaccination
Revue Scientifique et Technique de l'OIE
Human vaccinology, with its primary focus on the individual, seems far removed from veterinary medicine, with its concern for the health of the herd. Yet several episodes in the past (smallpox, fowl cholera, anthrax, swine erysipelas, rabies, tuberculosis, etc.) serve to illustrate the proximity between research on veterinary and human vaccines. In some cases the human vaccine was developed first, while in other cases it was the animal vaccine. The history of vaccinology clearly demonstrates the importance of these 'two medicines' working together. Foot and mouth disease (FMD) vaccines were among the first vaccines to be developed, beginning at the end of the 19th Century. Thanks to the discoveries of several researchers, including European researchers such as Vallée (French), Waldmann (German), Frenkel (Dutch) and Capstick (British), FMD vaccines began to be produced on an industrial scale from 1950 onwards, making possible vaccination of millions of animals in Europe and beyond. Vaccination strategies against FMD have always been dependent on the properties of the vaccines being used. At the beginning of the 21st Century FMD vaccines are designed in such a way that serological tests can differentiate infected from vaccinated animals, which has affected OIE regulations on international trade in animals and animal products. The history of vaccination against rinderpest, bovine contagious pleuropneumonia, and Marek's disease will also be dealt with.
Vaccine development: A historical perspective
Biomedical Research
Prevention from disease is always better than cure. The concept of preventing disease originated during the 17th century when Edward Jenner an English physician contributed to eradicating smallpox. Jenner's work is widely regarded as the foundation of prophylactic measure of disease by the vaccine, the term derived from "Vacca" means cow. The concept of the vaccine is slowly traveling from prophylaxis to therapeutic. However, therapeutic vaccines are under research and development. The first vaccine was developed using virus-infected lesions and in later stages many different types of vaccines such as toxoid vaccines, live attenuated vaccines, inactivated or killed vaccines and subunit vaccines have been formed. Modern advancement in biotechnology research had laid down for the development of the recombinant vaccine. However, the future trend of vaccine development is towards recombinant DNA technology and therapeutic vaccine for targeted diseases. This review article focuses on the historical perspectives of vaccine and the development of the vaccine as it is a core area of research where the life of the human is saved from various possible diseases
Vaccine Development Throughout History
Cureus, 2021
The emergence of the coronavirus disease 2019 (COVID-19) pandemic has made us appreciate how important it is to quickly develop treatments and save lives. The race to develop a vaccine for this novel coronavirus began as soon as the pandemic emerged. Time was the only limiting factor. From the first vaccine developed in 1796 against smallpox to the latest COVID-19 vaccine, there have been several vaccines that have reduced the burden of disease, with the associated mortality and morbidity. Over the years we have seen many new advancements in organism isolation, cell culture, whole-genome sequencing, and recombinant nuclear techniques. These techniques have greatly facilitated the development of vaccines. Each vaccine has its own development story and there is much wisdom to be gained from learning about breakthroughs in vaccine development.
More-than-national and less-than-global: The biochemical infrastructure of vaccine manufacturing
Economy and Society, 2022
The recent efforts to mount an R&D response to public health emergencies of international concern have led to the formation of what we term a biochemical infrastructure of vaccine development and production. In principle, this infrastructure is expected not only to curtail existing pandemics but also anticipate and contain yet-to-emerge future threats. Critically, by nature of its geographical distribution and technical modularity, that infrastructure promises both to accelerate and expand access to essential medical tools, and in so doing, redress global health inequities. In practice, however, the biochemical infrastructure of vaccines remains highly uneven, fragmented and unjust. Moving beyond calls for 'global health solidarity', this paper examines the key actors, normative techniques and socio-technical assemblages, from viral platform technologies to intellectual property waivers and from accelerated regulatory pathways to advance market commitments, that serve to link 'just-in-case' and 'just-in-time' modalities of
New challenges in assuring vaccine quality
Bulletin of the World Health Organisation
In the past, quality control of vaccines depended on use of a variety of testing methods to ensure that the products were safe and potent. These methods were developed for vaccines whose safety and efficacy were based on several years worth of data. However, as vaccine production technologies have developed, so have the testing technologies. Tests are now able to detect potential hazards with a sensitivity not possible a few years ago, and an increasing array of physicochemical methods allows a much better characterization of the product. In addition to sophisticated tests, vaccine regulation entails a number of other procedures to ensure safety. These include characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by national regulatory authorities, and enhanced preand post-marketing surveillance for possible adverse events following immunization. These procedures help assure vaccine efficacy and safety, and some examples are given in this article. However, some contaminants of vaccines that can be detected by newer assays raise theoretical safety concerns but their presence may be less hazardous than not giving the vaccines. Thus risk±benefit decisions must be well informed and based on scientific evidence.
The social, political, ethical, and economic aspects of biodefense vaccines
Vaccine, 2009
Besides natural disasters and naturally occurring novel infectious diseases, nothing potentially threatens the health and stability of nations and health systems as much as the devastating threat and unfathomability of bioterrorism. Other than attempts at political solutions and interdictive attempts, only antimicrobials and vaccines offer possible means for protection. Of these, vaccines offer the most immediate and definitive of preventive
Purpose – Global health objectives have stimulated changes to the international vaccine market. The authors seek to suggest that modern vaccine categories will aid in the formation of standardized clinical trial processes through the implementation of suggested policy strategies. Design/methodology/approach – A systematic review of literature for the period of 2000-2010 was conducted by searching academic databases of peer-reviewed articles (e.g. Medline, PsychInfo, and Social Science Citation Index) for multiple keywords, namely: clinical trial, regulatory standards, vaccine development, vaccine manufacturing, and vaccine distribution. The search yielded surprisingly few items that were able to provide an adequate baseline of clinical trial processes for fundamental analysis. Consequently, additional material was obtained through an exploratory literature review. The method included hand-searching reference lists and tables of contents and search engines (Google Scholar) for national and international clinical trial regulatory processes, global health organizations, and trends in vaccine marketing. Findings – Establishing modern vaccine designations is essential towards addressing the current trends of vaccine development. Identification of the market drivers will aid in the goal of establishing international protocols that can better position industry to streamline response in several areas including research, economic development, manufacturing, and distribution. Practical implications – Categorization of modern vaccine development can guide the international formulation of manufacturing and distribution policy strategies to elicit a cross-cultural global delivery system. Originality/value – This paper contributes to academic literature threefold. It categorizes vaccines, depicts the fundamental clinical trial phases vital to global health, and provides policy options driven by modern vaccine production designations. Paper type Conceptual paper