Hepatitis B Vaccine Freezing in the Indonesian Cold Chain: Evidence and Solutions

By Nelson, Carib M.; Wibisono, Hariadi et al. | Bulletin of the World Health Organization, February 2004 | Go to article overview

Hepatitis B Vaccine Freezing in the Indonesian Cold Chain: Evidence and Solutions


Nelson, Carib M., Wibisono, Hariadi, Purwanto, Hary, Mansyur, Isa, Moniaga, Vanda, Widjaya, Anton, Bulletin of the World Health Organization


Introduction

Immunization has been identified as one of the most cost-effective health interventions (1). The Global Alliance for Vaccines and Immunizations and the Vaccine Fund have stimulated international support of vaccination programmes by providing nearly US$1 billion to strengthen immunization systems and accelerate the introduction of new vaccines. Adequate cold-chain infrastructure and compliance are paramount for preserving the quality of these vaccines as they are distributed. Emphasis has long been placed on avoiding high temperatures during vaccine shipments, but, until recently, little attention has been focused on freezing of vaccines.

WHO guidelines for the use of hepatitis B, diphtheria--tetanus--pertussis, diphtheria--tetanus, and tetanus toxoid vaccines specify that they must not be frozen and should not be used if thought to have been frozen (2). The freezing of vaccines that contain liquid formulations of diphtheria, tetanus, pertussis, and hepatitis B vaccines leads to a loss of potency and compromised protective immunogenicity in recipients (3-6).

Although WHO guidelines and vaccine labels state that these vaccines should be stored at temperatures of 2-8 [degrees]C, cold-chain temperatures <0 [degrees]C are common. Recent studies in Australia (7-9), Canada (6), Hungary (17), Malaysia (16), Mongolia (18), Pakistan (15), the United Kingdom (10-12), the United States (13, 14) and other countries have found widespread freezing at many stages of the vaccine distribution system. Improperly adjusted refrigeration equipment, poor compliance with cold chain procedures, inadequate monitoring, and poor understanding of the dangers of freezing result in frequent cold-chain freezing. Studies in China and Indonesia showed that hepatitis B and tetanus toxoid vaccines can be stored and used at temperatures >2-8 [degrees]C while retaining full immunogenicity (19, 20).

Indonesia recently implemented a policy of storing hepatitis B vaccine in midwives' homes at ambient temperatures (21). Although the impetus for ambient temperature storage of these vaccines was for programmatic benefit, reduced freezing was a probable side benefit. Few data have been published on removing vaccines from the cold chain to prevent freezing.

This study aimed to characterize the frequency of freezing temperatures that occur in the Indonesian vaccine cold chain and to evaluate the feasibility of several modifications to the cold chain that were designed to reduce freezing.

Methods and materials

Study sites

The study took place in the Indonesian provinces of East Java and Nusa Tenggara Barat from September 2001 to June 2002. Two districts in each province and two health centres in each district were chosen, which gave a total of eight health centres. Although sites were not selected randomly, a wide range of transport distances, accessibility, and infrastructure situations were sought.

The ambient temperatures in the study districts and along transport routes ranged from 19-36 [degrees]C. Typically the minimum and maximum temperature lay in the range of 22-32 [degrees]C. Average temperatures were 26-29 [degrees]C.

Equipment and supplies

Data loggers

Tiny TTM data loggers (Remonsys Limited, Witney, UK) were programmed to take temperature readings at two-hour intervals.

Uniject devices

Standard 0.5-ml Uniject prefill injection devices (BD Pharmaceutical System, Franklin Lakes, NJ, USA) were filled with recombinant hepatitis B vaccine through standard filling procedures by PT Bio Farma (Bandung, Indonesia).

Vaccine vial monitors

Type VVM30 vaccine vial monitors (LifeLines Technology, Morris Plains, NJ, USA) were shipped to PT Bio Farma and applied to Uniject pouches just before shipment to the provinces. The vaccine vial monitors underwent standard quality assurance procedures before they were attached to the Uniject pouches. …

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