Accomplishments
While it is extremely difficult to determine the contribution of different factors influencing a change in situation in a country, and thus the relative impact of the activities of the ISPP, there has undoubtedly been substantial global progress in the area of immunization safety over the lifetime of the Project.
Two mechanisms for measuring global progress used by the Project are injection safety assessments and the WHO/UNICEF Joint Reporting Form (JRF) on vaccine-preventable diseases.
The JRF has been used as a standard data collection tool since 1998. The immunization safety situation is captured through a set of eight indicators that provide information on policy, designated budget allocations, monitoring, equipment and practices.
In February 2003, a report of the information relating to immunization safety provided through the JRF by countries for the years 2000 and 2001 was published in the WER.
In April 2005, an update was published in the WER. The article compared immunization safety data provided by countries through the JRF for 2001 and 2003 and commented on how this data could be interpreted in terms of progress in immunization safety worldwide.
Summary of comparison of 2001 and 2004 data
Safe injections component of national workplan
The proportion of non-industrialized1 countries reporting that they had, as part of their annual workplan for immunization, a safe injections component detailed to the district level increased from 64% in 2001 to 70% in 2004.
Percentage of WHO member states reporting a safe injections (including sharps waste management) component of the national workplan detailed to the district level
Use of auto-disable (AD) syringes
The proportion of non-industrialized countries using AD syringes for routine immunization increased from 42% in 2001 to 62% in 2004.
Percentage of non-industrialized countries using AD syringes for routine immunization
Percentage of non-industrialized countries using AD syringes exclusively and non-exclusively for routine immunization
Despite a gradual increase, AD syringe use was still low in 2004. Of non-industralized countries, 38% reported exclusive use of AD syringes in their immunization programme in 2004. A substantial increase in exclusive use of AD syringes was observed in both the African Region (four-fold) and the South-East Asia Region (eight-fold). In the other regions, however, the situation remained unchanged. The Vaccine Fund of the Global Alliance for Vaccines and Immunization (GAVI) and other donors provided substantial assistance for the introduction of AD syringes into immunization services in some of the poorest countries. As at July 2005, over US$ 114 million had been committed to Vaccine-Fund eligible countries for injection safety by the Vaccine Fund.
The procurement of AD syringes for immunization through UNICEF increased from 210 million in 2001 to 442 million in 2003. Procurement of AD syringes beyond the infant immunization schedule (e.g. for school-based or adult routine immunization services) is still hampered by lack of government commitment and additional financing needed to switch to AD syringes.
Budget lines
For 2004, 67% of 141 non-industrialized countries that provided an answer had an available budget line for the purchase of injection supplies for routine immunization, indicating a decline compared with the 78% reported in 2001. This decline is concerning. The highest proportion of countries with no dedicated budget line is found in the European Region, primarily related to economies in transition where injection supplies are likely to be secured from other sources (e.g. health insurance) rather than national budgets and in WPRO.
Distribution of sharps boxes
The distribution of sharps boxes bundled (matching quantities of injectable vaccines with the required quantity of syringes and sharps boxes) with vaccine deliveries in non-industrialized countries increased from 57% in 2001 to 73% in 2004. A notable increase was recorded in the African and South-East Asian Regions. The results of the injection safety assessments undertaken confirm the data reported on the JRF but indicate that bundling is not completely achieved at all facilities within the countries.
Waste disposal
In terms of country reports on recommended practices and policies for immunization waste disposal, in 2004 58% of non-industrialized countries relied on several methods of waste disposal, compared with 51% in 2001. An increased proportion of non-industrialized countries reported use of incineration (74% in 2004 versus 59% in 2001) and burial (45% in 2004 versus 34% in 2001), both of which are considered acceptable by WHO when carried out according to proper procedures/standards. The proportion of countries still reporting use of open burning (considered unacceptable by WHO) unfortunately increased to 50% in 2004. These data are difficult to interpret because the quality of the data and adherence to correct implementation of reported policies are uncertain. Waste management practices as reported in the JRF and outcomes of the injection safety assessments confirm however that environmental issues remain a significant concern.
Monitoring system for adverse events following immunization (AEFIs)
In 2004, 68% of countries reported having a national system for surveillance of adverse events following immunization (AEFI), compared with 53% in 2001. The increase is largely a reflection of better reporting, although there are regional differences. The African Region, the European Region and the South-East Asian Region reported the largest increases in AEFI surveillance systems during the period.
Of countries reporting the existence of an AEFI surveillance system, 20% indicated that no serious adverse events were reported in 2004, compared with 27% in 2001. The absence or small number of AEFI reports for some fairly populated countries casts doubt on the functionality of their surveillance systems. Direct interactions with national regulatory authorities and national immunization programmes provide better insight into the ability of countries to respond to adverse events. Based on data for 2004, 35% of countries were estimated to have a functional AEFI surveillance system.
1. The term "non-industrialized countries" uses country economic categories defined by the United Nations World Economic and Social Survey. The subset includes the least-developed countries, developing countries and economies in transition.