Countries’ interest in a hepatitis B vaccine licensed for the controlled temperature chain; survey results from African and Western Pacific regions

• Published in: Vaccine Vol. 35; no. 49; pp. 6866 - 6871
• Main Authors: Petit, Dörte, Tevi-Benissan, Carole, Woodring, Joseph, Hennessey, Karen, Kahn, Anna-Lea
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 14.12.2017; Elsevier Limited; Elsevier Science
• Subjects: Africa - epidemiology; Birth; Birth dose; Births; Chronic infection; Cold; Cold storage; Controlled Temperature Chain (CTC); Drug delivery systems; Female; Health facilities; Hepatitis; Hepatitis B; Hepatitis B Vaccines - administration & dosage; Hepatitis B Vaccines - chemistry; Hepatitis B Vaccines - economics; Hepatitis B, Chronic - epidemiology; Hepatitis B, Chronic - prevention & control; Hepatitis B, Chronic - virology; Humans; Immunization; Infections; Infectious Disease Transmission, Vertical - prevention & control; Licenses; Licensure; Male; Meningitis; Newborn babies; Procurement; Refrigeration; Surveys and Questionnaires; Temperature; Temperature effects; Temperature requirements; Thermostability; Vaccination; Vaccination - economics; Vaccination - legislation & jurisprudence; Vaccination - statistics & numerical data; Vaccination Coverage - methods; Vaccination Coverage - statistics & numerical data; Vaccines; World Health Organization; East Asia; Thermostability; Birth dose; Vaccination; Hepatitis B; Controlled Temperature Chain (CTC)
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2017.10.025

•There is a demand from countries for a hepatitis B vaccine product licensed for Controlled Temperature Chain (CTC).•CTC is considered to be a cost efficient approach to improve coverage and equity.•CTC was viewed as potential relief for facilities without continuous cold chain.•Vaccination of babies born at home would be greatly facilitated by the CTC approach.•This study highlights that countries still require comprehensive orientation to CTC. Chronic hepatitis B infection can be prevented by hepatitis B vaccine birth dose (hepB-BD) given within 24 h after birth, followed by two hepatitis B vaccinations within the first year of life. Yet nearly half of World Health Organization (WHO) Member States do not provide a hepB-BD. Barriers are primarily attributed to vaccine storage and transportation, as well as high rates of home births. Delivering the vaccine outside the cold chain could potentially increase coverage. To do this, WHO recommends vaccines be licensed for use in a “controlled temperature chain” (CTC), which requires a given product to tolerate temperature excursions up to at least 40 °C for a minimum of three days. To date, no hepB vaccine is labelled for CTC. To inform dialogue with manufacturers, WHO conducted a survey among countries in the African and Western Pacific Regions (AFR and WPR) to assess demand for a hepatitis B product licensed for use in a CTC. Twenty-five (44%) countries responded, with 8 of 11 (73%) from the WPR and 17 of 46 (37%) from the AFR. Of these responding countries, 5 in AFR and all 8 in WPR have introduced universal hepB-BD. Seventy-two percent indicated that CTC would facilitate the provision of hepB-BD. While no overall difference in responses was detected between countries either providing or not providing hepB-BD, countries that already introduced hepB-BD but had low hepB-BD coverage were particularly interested in CTC. Irrespective of hepB-BD policy, responding countries suggested that a CTC-licenced product would be beneficial, though the price of such a vaccine would influence procurement decisions. This survey was beneficial to inform the CTC agenda. However, countries' lack of experience with HepB-BD as well as with CTC and the fact that countries were commenting on a product that is not yet on the market should be acknowledged.