Lessons on causality assessment and communications from the 2019 South-East Asia Regional (SEAR) workshop on inter-country expert review of selected Adverse Events Following Immunization (AEFI) cases.

BACKGROUND: Surveillance of AEFI is fundamental for improving safety and maintaining public support for vaccination. In SEAR, billions of doses of vaccine are given annually. The objective of the 2019 SEAR AEFI training workshop was to further strengthen in-country vaccine safety, assess capacity compared to 2014 and to better integrate communication into the AEFI causality assessment program. METHODS: A 3 ½ day workshop with AEFI experts from all 11 SEAR countries. Participants outlined each county's AEFI data, critiqued their AEFI program, reviewed and critiqued causality assessment of 23 anonymized serious AEFI cases and proposed communication plans for each. RESULTS: Between 2016 and 2018, over 2.9 billion doses of vaccine were given in SEAR. Compared to 2014, AEFI detection and causality assessment skills had improved. AEFI experts' communication planning skills markedly improved during the workshop. Good concordance was found between country causality assessment findings and the workshop critiques. A list of targeted recommendations (country, regional and global levels) arose from the workshop. CONCLUSIONS: SEAR countries have much improved their AEFI detection and causality assessment expertise since 2014. Given the high volume of doses administered and the AEFI technical expertise, SEAR countries can well monitor safety of regionally produced vaccines. Integration of AEFI communication into AEFI causality assessment can help mitigate potential negative impacts of serious AEFIs.

Strengthening of causality assessment of adverse events following immunization in the WHO South East Asia and Western Pacific regions: Lessons from the 2014 SEAR inter-country workshop.

BACKGROUND: Poorly managed AEFI undermine immunization programs. Improved surveillance in SEAR countries means more AEFIs but management varies. SEAR brought countries together to share AEFI experiences, and learn more about causality assessment. METHODS: Three day 10 country workshop (9 SEAR; 1 WPR). Participants outlined county AEFI experiences, undertook causality assessment for 8 AEFIs using WHO methodology, critiqued the process by questionnaire and had a discussion. RESULTS: All 10 valued AEFI monitoring and causality assessment, and praised the opportunity to share experiences. Participants determined a range of AEFI and causality assessment needs in SEAR such as adapting WHO Algorithm, CIOMS/Brighton definitions, WHO verbal autopsy to fit context, requesting a practical guide--AEFI definition, time interval, rates of AEFI for different vaccines and evidence for vaccine related causes of death under 24h. CONCLUSIONS: LMIC need WHO AEFI tools adapted to better fit LMIC. Learning from each other builds capacity. Sharing AEFI experiences, case reviews help LMIC improve practices.

Effective vaccine safety systems in all countries: a challenge for more equitable access to immunization.

Serious vaccine-associated adverse events are rare. To further minimize their occurrence and to provide adequate care to those affected, careful monitoring of immunization programs and case management is required. Unfounded vaccine safety concerns have the potential of seriously derailing effective immunization activities. To address these issues, vaccine pharmacovigilance systems have been developed in many industrialized countries. As new vaccine products become available to prevent new diseases in various parts of the world, the demand for effective pharmacovigilance systems in low- and middle-income countries (LMIC) is increasing. To help establish such systems in all countries, WHO developed the Global Vaccine Safety Blueprint in 2011. This strategic plan is based on an in-depth analysis of the vaccine safety landscape that involved many stakeholders. This analysis reviewed existing systems and international vaccine safety activities and assessed the financial resources required to operate them. The Blueprint sets three main strategic goals to optimize the safety of vaccines through effective use of pharmacovigilance principles and methods: to ensure minimal vaccine safety capacity in all countries; to provide enhanced capacity for specific circumstances; and to establish a global support network to assist national authorities with capacity building and crisis management. In early 2012, the Global Vaccine Safety Initiative (GVSI) was launched to bring together and explore synergies among on-going vaccine safety activities. The Global Vaccine Action Plan has identified the Blueprint as its vaccine safety strategy. There is an enormous opportunity to raise awareness for vaccine safety in LMIC and to garner support from a large number of stakeholders for the GVSI between now and 2020. Synergies and resource mobilization opportunities presented by the Decade of Vaccines can enhance monitoring and response to vaccine safety issues, thereby leading to more equitable delivery of vaccines worldwide.

Vaccine wastage in Bangladesh.

The Government of Bangladesh and WHO collaborated in a retrospective vaccine wastage study to estimate overall vaccine wastage rates from January to December 2004 for BCG, measles, DTP and TT. Researchers looked at vaccine distribution and usage patterns in randomly selected districts at both fixed (Upazila) and outreach (Ward) service delivery levels. Wastage was similar at both delivery levels but ranged widely among the sites. Average rates were highest for BCG (84.9%, range 55-93%) and measles (69.7%, range 28-86%) and lower for TT (35.5%, range 10-73%) and DTP (44.4%, range 16-77%). Wastage resulted primarily from opened vials at the ward level but this was reduced at fixed sites where the multi-dose vial policy is followed. A large proportion (30-38%) of records were excluded from the analytic vaccine-specific databases due to data recording errors, mismatches between Ward and Upazila databases, or missing data. The study's results may provide methodological and programmatic guidance for other countries in addressing vaccine wastage issues.

Use of cool water packs to prevent freezing during vaccine transportation at the country level.

OBJECTIVES: To study the impact of the use of cool water packs (water packs refrigerated at 2 to 8 degrees C) on the cold life of vaccine transport boxes and the shelf life of the vaccines. METHODS: Data loggers were used to measure the temperatures of vaccine shipments with cool water packs in laboratory studies and country evaluations. The temperature recordings were mathematically translated into reduction of vaccines shelf life, which are illustrated through degrees of color changes of Vaccine Vial Monitors. FINDINGS: Laboratory studies at extreme ambient temperatures (43 degrees C) showed that, with the use of cool water packs, temperatures inside the cold box rise to around 20 degrees C within 48 h. When this exposure scenario was repeated four times, the impact of the temperature history on the different heat stability categories of vaccines varied between 2.4 and 36.0% shelf life loss. Oral polio vaccine was found to be the most affected vaccine. All other vaccines were affected with 2.4 to 10.4% life loss. Country assessments (real life situation with temperature variations between day and night) showed between 0.4% to 4.6% life loss when the boxes were exposed to ambient temperatures ranging from 11.7 to 39.8 degrees C over the 98 h 15 min test period. CONCLUSIONS: The use of cool water packs is found to be a legitimate and safe practice for vaccines other than oral polio vaccine, so that cool water packs can safely replace frozen icepacks without any serious consequences on the ability of vaccines to confer protection against disease.