Vaccines                                                                   

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General
  • A vaccine is a preparation which is used to improve immunity to a particular disease.
  • Vaccines have contributed to the eradication of smallpox, one of the most contagious and deadly diseases known to man. Other diseases such as rubella, polio, measles, mumps, chickenpox, and typhoid
  • Vaccines containing killed microorganisms - these are previously virulent micro-organisms that have been killed with chemicals or heat.
  • The immune system recognizes vaccine agents as foreign, destroys them, and 'remembers' them. When the virulent version of an agent comes along the body recognizes the protein coat on the virus, and thus is prepared to respond, by (1) neutralizing the target agent before it can enter cells, and (2) by recognizing and destroying infected cells before that agent can multiply to vast numbers  Vaccination is the administration of antigenic material (the Vaccine) to produce immunity to a disease.

Application

  • Biotechnological tools applied to genome-based approaches has revolutionized vaccine development, biological research and clinical diagnostics.
  • DNA vaccination with mammalian-expressible plasmid DNA encoding protein antigens is known to be an effective means to elicit cell-mediated immunity, sometimes in the absence of a significant antibody response.
  • By applying appropriate tools for genomic mining to the published sequence of Haemophilus influenzae Rd genome, it was possible to identify a putative vaccine candidate, the outer membrane lipoprotein, P6.
  • The application of proteomics for identification of vaccine candidates for another pathogenic bacterium, Helicobacter pylori using two different approaches is described. The first involves rapid identification of a series of monoclonal antibody reactive proteins from N-terminal sequence tags. The other approach involves identification of proteins in outer membrane preparations by 2-D electrophoresis followed by trypsin digestion and peptide mass map analysis.

Product

  • FDA's Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines in the United States.
  • The production of vaccines after the vaccine and the manufacturing processes are approved, in order to ensure continuing safety. After licensure, monitoring of the product and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product.
  • This study examines the hypothesis that the suspected divergence of vaccine product lines between industrialized and developing countries could threaten the public sector vaccine supply goal to ensure availability of quality affordable vaccines to meet priority needs of developing countries.

Process

  • The peculiarities of the course of the brucellosis vaccinal process under the conditions of radiation were studied using bacteriological and immunological methods.
  • The central issue related to technology is the evolution and translation from a procedure used for making vaccines in a basic research laboratory to a process that can be scaled up and run reproducibly in a manufacturing environment to make tens of millions of doses per year.
  • The central issue related to technology is the evolution and translation from a procedure used for making vaccines in a basic research laboratory to a process that can be scaled up and run reproducibly in a manufacturing environment to make tens of millions of doses per year.

Market

  • The five largest vaccine businesses dominate the market today, but Acambis is targeting a series of significant opportunities to establish itself as a major player in the worldwide vaccines industry.
  • Newer vaccines, new technologies, and emerging diseases are, however, giving rise to considerable increases in the overall market. Prevnar (Wyeth), a heptavalent conjugate vaccine, has accelerated to a $1 billion plus product  since launch as recently as 2000, with sales likely to double just in the third quarter in 2003.
  • In assessing the market for vaccine products, Kalorama Information provides sales data for the 2001-2003 historical years, the 2004 base year, and the 2001 through 2010 forecast years.

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