ANSI - American National Standards Institute
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Fifty Years After Polio Vaccine: International Standards Assist Immunization Programs and Policies around the World

New York, Apr 12, 2005

A half century ago today, the vaccine against polio was declared safe and effective by Dr. Jonas Salk. Because of his research work and subsequent successful immunization programs, millions of children and adults have been protected from contracting the paralyzing disease. Unfortunately, polio has not been completely eradicated in some underdeveloped countries, and immunization efforts against many diseases are still critically needed. Teams in the Department of Immunization, Vaccines and Biologicals (IVB) of the World Health Organization (WHO) depend on international standards and consensus in their fight against diseases like polio, measles, tetanus, and AIDS/HIV.

One of these IVB teams – Quality Assurance and Safety of Biologicals – has as its mission “To ensure the quality and safety of vaccines and other biological medicines through the development and establishment of global norms and standards.” Its targets are guidelines on production and quality control, international consensus on safety and quality issues, technical advice to national regulatory authorities and national control laboratories, and methods, requirements, international standards and reference preparations and advice on how to use them.

WHO’s immunization safety program covers the assurance of vaccine safety and quality from production through to administration, the safety of injections and vaccine delivery systems, the management of sharps and waste disposal, and the monitoring and management of adverse events following immunization. The International Organization for Standardization’s (ISO) Technical Committee 84/Subcommittee 1 on Syringes, needles and intravascular catheters for single use has published a number of standards that are used as benchmarks by WHO. These include:

  • ISO 7864:1993 Sterile hypodermic needles for single use

  • ISO 7886-1:1993 Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use

  • ISO 7886-2:1996 Sterile hypodermic syringes for single use -- Part 2: Syringes for use with power-driven syringe pumps

  • ISO 7886-3:2005 Sterile hypodermic syringes for single use -- Part 3: Auto-disable syringes for fixed-dose immunization

ISO also agreed to begin work on a part four of the standard for hypodermic syringes with a reuse prevention feature (ISO 7886-4) while the subcommittee was finalizing the draft of part three for auto-disable syringes for immunization (ISO 7886-3); this standard is currently in development. Where ISO standards are not available, WHO will provide procurement specifications and laboratory test procedures.

Sadly, today there are still 1263 cases of polio worldwide. While this number may seem small in comparison to other endemic diseases, poliovirus can spread widely and rapidly, and the effort to bring the number of afflicted to zero is substantial. The World Health Organization, Rotary International, the Centers for Disease Control and Prevention, and the United Nations Children's Fund (UNICEF) are global partners in the Global Polio Eradication Initiative that was launched in 1988 with the goal of eradicating polio by the year 2000; their efforts continue. Since the initiative's founding, the number of cases has fallen by more than 99 percent.

 Homeland Defense and Security Standardization Collaborative