Oral polio vaccine , requirements

In 1999, WHO published requirements for production and control of Haemophilus influenzae type b (Hib) conjugate vaccine and the acellular perussis component of monovalent or combined vaccines. The requirements for oral polio vaccine (OPV) were also revised in 1999, with several additions. WHO published new and replacement International Standards and Reference Materials covering a wide range of products.f ... 

An analogous example in the civilian context could be made in the case of polio immunizations, where a 1 in 2.4 million chance exists that an oral polio virus vaccine will actually cause the disease. The risk posed by the vaccine is extremely small, but it is real, and yet poliomyelitis hasn t been seen in the Western Hemisphere since 1991. On an individual basis, a case could be made that the chances of acquiring polio, unless one travels abroad or has contact with people from endemic regions, is even less than that of acquiring vaccine-associated paralytic poliomyelitis. But there is no question that continued polio vaccinations are required in the United States, and indeed a global eradication campaign is underway to completely eliminate the virus. 

Live Attenuated Organisms. Live attenuated bacteria and viruses have been used not only as vaccines but also as a delivery system that elicits humoral, mucosal, and cellular immune responses against exogenous antigens. Since the success with live attenuated oral vaccines against tuberculosis and polio more than 3 decades ago, a number of live attenuated microorganisms have been used as antigen-delivery systems. Live vaccines are relatively easy and cheap to manufacture, because they do not require purification of... 

The health status of animals from which starting materials are derived and of those used for quality control and safety testing should be monitored and recorded. Staff employed in animal quarters must be provided with special clothing, changing facilities and showers. Where monkeys are used for the production or quality control of biological products, special consideration is required, as laid down in the revised Requirements for Biological Substances No. 7 (Requirements for Polio-myelitis Vaccine (Oral))(5). 

---