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The safety of immunization delivery improves over last five years, but challenges remain

Considerable progress has been made by countries during the last five years in ensuring the safety of all immunizations given through their national immunization programmes, but many challenges remain, according to an expert Committee of the World Health Organization (WHO).

"When the safety of immunization is not assured, there are both human and economic costs. We are seeing very encouraging progress. More and more countries are using auto-disable syringes, ensuring safe disposal of immunization-related waste, strengthening their regulatory authorities, and monitoring and managing adverse events following immunization. But we are still falling short of our goals in these four areas," said Dr Philippe Duclos, the Medical Officer leading WHO's Immunization Safety Priority Project.

The WHO Steering Committee on Immunization Safety provides its assessment of progress and remaining gaps in the report of its sixth meeting, published today in the WHO Weekly Epidemiological Record1. The Committee, which met on 21-22 September, issued a number of recommendations for further action, in the following four areas:

Auto-disable syringes

According to data reported to WHO and the United Nations Children's Fund (UNICEF), the proportion of non-industrialized countries using auto-disable (AD) syringes (a syringe that is automatically disabled after use in order to prevent re-use) for routine immunization increased from 42% in 2001 to 62% in 2004. Factors contributing to this increase have included the realization by countries of the importance of injection safety, the increase in the number of manufacturers producing AD syringes meeting WHO specifications and the support provided to countries by the Vaccine Fund/Global Alliance for Vaccines and Immunization (GAVI)2.

While encouraging, this progress falls short of the goal set in 1999 by WHO, UNICEF, the United Nations Population Fund and the International Federation of Red Cross and Red Crescent Societies, with 97 non-industrialized countries3 continuing to use reusable syringes, either exclusively, or in combination with AD syringes.

Immunization-related waste

Non-industrialized countries continue to use a variety of methods—including incineration (74%) burial (45%) and open burning (50%)—for disposal of immunization-related waste. Environmental issues remain a significant concern as open burning is not considered by WHO to be an acceptable means of disposing of immunization-related waste. Effective waste management continues to present a major challenge to the use of disposable injection equipment.

The Steering Committee recommended further studies on new disposal technologies such as needle-remover devices, the inclusion of waste management in the budgets of national immunization programmes and the treatment of immunization-related waste as an integral component of medical waste management.

National regulatory authorities (NRAs)

Responsibility for quality and safety of vaccines rests with the NRA in the country of manufacture and, where exported, with the NRA of the receiving country. The Steering Committee noted that significant progress had been made in developing and strengthening NRAs but that in some countries many challenges needed to be addressed in order for the NRA to exercise all relevant regulatory functions. It recommended that strengthening of NRAs remain a high priority for both WHO and countries.

Adverse events following immunization (AEFIs)

The monitoring and management of AEFIs are essential elements in maintaining public confidence in immunization programmes. In 2004, 68% of countries reported the existence of a national system for the surveillance of AEFI, compared with 53% in 2001.

There remain, however, many challenges in ensuring that all countries have a functional AEFI surveillance system. The Steering Committee recommended that countries continue to develop their capacity to detect, investigate, manage, and communicate findings on AEFIs and that WHO facilitate the development of capacity to monitor adverse events at the global level.

It should be noted that serious AEFIs are rare and most are not caused by vaccines; the majority are coincidental, while others are related to preventable errors in the storage, handling or administration of vaccines.

The Steering Committee concluded that the ultimate responsibility for assuring immunization safety rests with national governments but highlighted a couple of good opportunities at the global level for improving immunization safety.

The World Alliance for Patient Safety, launched in Washington, D.C. in October 2004, provides a framework for agencies, policy-makers and patients' groups from across the world to advance the patient safety goal of "First, do no harm" and reduce the adverse health and social consequences of unsafe health care. In addition, the G8 summit recommended in July 2005 that WHO, the Joint United Nations Programme on HIV/AIDS (UNAIDS) and other international bodies develop and implement a package of HIV prevention, care and treatment services: this presents an opportunity to coordinate activities for the reduction of HIV infection resulting from injections with contaminated syringes.

1WHO Weekly Epidemiological Record,
2Sufficient AD syringes and safety boxes (or the equivalent amount of funds) for immunization according to the standard Expanded Programme on Immunization schedule for three years upon approval of an application to GAVI.
3Number of non-industrialized countries reporting use of standard disposable and/or sterilizable syringes in 2004.


For more information contact:

Melinda Henry
WHO Department of Immunization, Vaccines and Biologicals, Geneva
Telephone: +41 22 791 2535
Fax: +41 22 791 4858