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.

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 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