Thermal stability of conjugate vaccines: using vaccines outside the cold chain

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1 Thermal stability of conjugate vaccines: using vaccines outside the cold chain Vaccine World MENA & CIS 2014 Istanbul, 20 November 2014 F Marc LaForce, MD Serum Institute of India, Ltd

2 What is the cold chain? Vaccines are sensitive to heat and must be kept cold from the time they are manufactured until they are used. The equipment and people that keep vaccines cold during their journey are together called the cold chain. 2

3 The Cold Chain

4 Recommended Storage Temperature for Vaccines Vaccines OPV BCG Measles Penta TT Note: National Provincial District Facility 6 months 3 months 2 months 1 month -15 C to -25 C Level/Max stock in months + 2 C to + 8 C 1.BCG and Measles can be stored and transported at +2 C to +8 C. It is not harmful to store them at minus temperature but it is unnecessary. 2.Diluent vials must never be frozen, they must be stored and transported at +2 C to + 8 C when packed together with the vaccine. 4

5 Cold chain challenges and solutions

6 Cold chain challenges and potential solutions Challenges 23,000 facilities with missing equipment (2013) Lack of maintenance systems $ M funding gap for Equipment Solutions Expand the cold chain to unequipped health facilities Support development of new cold chain equipment Emerging technologies : passive devices, solar technology, etc. Thermostability solutions Take advantage of existing stability data Encourage vaccine companies to explore new efforts towards more thermostable vaccines

7 Which are most sensitive to heat?

8 Heat stability of Men C conjugate Men C conjugate vaccine (Menjugate) Subjects months of age (RCT 500 toddlers) Test vaccines Men C conjugate stored at 2-8 C for 6 months Men C conjugate stored at room temperature (25 C) for 6 months Test parameters SBA and IgG ELISA 1 and 28 days after vaccination Results No difference between the two groups Schondorf et al, Vaccine 25:1175, 2007

9 October 2012 MenAfriVac License Variation MenAfriVac obtains a license variation from its regulatory agency (the DCGI) and is prequalified by WHO, for use in a Controlled Temperature Chain (CTC) License allows use of MenAfriVac up to 4 days at temperatures up to 40 C

10 MenAfriVac vaccine roll out Cumulative number of vaccinated persons 180,000, ,000, ,591, ,000, ,000, ,000, ,181, ,000,000 60,000,000 54,613, ,000,000 20,000,000 19,154, Target Countries: Burkina Faso, Mali, Niger, Nigeria, Chad, Cameroon, Sudan, Ghana, Benin, Senegal, Ethiopia, DRC, South Sudan, Cote d Ivoire, Togo, Uganda, Guinea, The Gambia, CAR, Eritrea, Kenya, Burundi, Guinea Bissau, Mauritania, Rwanda, Tanzania Target population 2014 = 69,949,250

11 Taking advantage of CTC With functioning cold chain at health center: vaccines are used outside the cold chain the day of vaccination and no ice packs are needed. For remote and hard to reach areas: vaccination teams are able to stay overnight for 3 days facilitating logistics since teams do not have to return each night to the health center. No cold chain/ lack of cold chain space: vaccines can be stored in a CTC for 4 days and eliminating up to 8 trips to district level cold chain facilities.

12 Benin study of Men A conjugate vaccine Use of Meningitis A conjugate vaccine in a controlled temperature chain (CTC) in Banikoara district December 2012

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16 Controlled temperature chain (CTC) study in Benin (December 2012) CTC implemented in one district: Banikoara Strict 2-8 C cold chain maintained from national to the district level Special training and supervision in the district, with emphasis on adverse events monitoring individuals vaccinated without cold chain Administrative coverage 106% No significant wastage due to CTC practice (only 9 vials discarded)

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19 Observations No increase in AEFIs reported Teams felt CTC helped them increase coverage When given a choice, 100% of supervisors and 98.7% of vaccinators would prefer to conduct their next campaign using CTC, if possible. No confusion in future campaigns - cold chain conditions properly followed during Polio NID (vaccines at 2-8 C) implemented 10 days after MenA campaign in Banikoara

20 Model of Men A CTC in Chad projects a 50% decline in cold chain costs with CTC

21 Next steps CTC approach well suited to campaigns and special strategy situations, single antigen setting CTC has the potential to reduce cold chain costs and health care worker logistics Can the CTC strategy be expanded? Manufacturer buy in Regulatory pathways clear Interest from GAVI, WHO and UNICEF

22 Acknowledgements Optimize/PATH - Simona Zipursky and Michel Zaffran WHO/HQ Olivier Ronveaux Meningitis Vaccine Project Jean-Marie Preaud Serum Institute of India MenAfriVac product development team PATH/DC Sophie Haralson