Vaccine Cold Chain in a Continental Country Brazil

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1 Vaccine Cold Chain in a Continental Country Brazil GISELE MIRANDA 2018 FLY PHARMA US 11 SEP 2018

2 Fiocruz / Bio-Manguinhos Part of the MoH 118 years old Biggest health institution in Brazil Presence in 10 states + one country in Africa Focus in public Health Activities: R,D&I Education Health assistance Production and supply of medicines and vaccines Museum

3 Immunization in Brazil Vaccination against Smallpox since 1804 Mass vaccination against smallpox in Rio de Janeiro in early 1900 Sanitary reform and elimination of cholera, plague, YF and smallpox results: the vaccine uprising

4 National Immunization Program The success of national vaccination campaign against Smallpox and its erradication in 1971 Establishment of the NIP in 1973 to guarantee the continuity, equity and gratuity Centralized planning and guidance, but shared responsibilities with states and districts

5 National Immunization Program s Callendar age BCG Hep B DTP-HB - Hib At birth Single dose Birth dose OPV/ IPV Pneumo Rota Men C YF MMR Varicella Hep A Td HPV dtpa Influenza 2 months 1 st dose 1 st dose 1 st dose 1 st dose 3 months 1 st dose 4 months 2 nd dose 2 nd dose 2 nd dose 2 nd dose 5 months 2 nd dose 6 months 3 rd dose 3 rd dose 1 st dose 9 months Single dose 16 different vacines 20 diseases > 37 doses / person 12 months Booster dose 1 st Booster Single dose Single dose 15 months 1 st Booster (DTP) 1 st Booster (OPV) Single dose Booster every year 4 years 2 nd Booster(DTP) 2 nd Booster (OPV) 9 years 2 doses doses 2 nd Booster Single dose Booster every 10 years years years 3 doses Single dose Booster every 10 years doses Single dose Booster every 10 years Booster every year Pregnant 3 doses 2 doses Single dose

6 Why is it a big challenge?

7 Continental country: km² (US km²) districts 208.7K inhabitants (US 325,7 milhões)

8 Road infrastructure: km roads only 12,3% are paved roads

9 More than immunization facilities

10 Large urban áreas (São Paulo 12.1 million 7th bigger city of the world) X Rural areas (15% in isolated areas)

11 2018 Population pyramid Large population of children under 4Yrs + 14,8K under 4yrs 26,4K over 60 yrs Growing population over 60ysr men women 2010

12

13 A long way to reach one child A journey to an Amazonian village

14 Vaccine Distribution Scheme Decentralized control of the operations and resources (industry, MoH, States, Districts...) NIP is responsible for the guidance and training Shared responsibilities for the information and planning

15 Temperature sensitivity of vaccines

16 Acceptable Acceptable Acceptable WHO recommended vaccine storage temperatures and maximum storage periods National (up to 12 months) Sub-National (up to 6 months) District (up to 3 months) Service (up to 1 months) +8ºC Liquid Lyophil Liquid Lyophil Liquid Lyophil Liquid Lyophil +2ºC All OPV -15ºC All OPV Lyophil All OPV Lyophil All OPV Lyophil -25ºC

17 Bio-Manguinhos (vaccine manufacturer)

18 CENADI (Vaccine s National Storage and Distribution Center)

19 Special cold box design

20

21 Sub-national central stores

22 Going to the last mile

23

24 Support from the Brazilian Army

25

26 Immunization room - routine

27 Outreach immunization National Immunization day

28 Open markets Schools Beaches Parks Churches...

29

30 Never loose the opportunity to vaccinate

31

32 How to ensure the quality of the service? Right product Right quantity Right condition Right place Right time Right cost

33 Cold Chain Guidelines - NIP Guidelines of Good Storage and Distribution Practices revised consistently Types and characteristics of each immunobiological Thermodinamics Maintenance of equipments Quality system Safety guidelines Control and monitoring instruments Supply planning tools New Technologies

34 Preparing the dose Handling the vacines How to administer MDVP Never loose the opportunity to vaccinate

35 Temperature control devices Temperature mesuring devices Wired digital thermometer Cold room Cold box (transport) Cold box (immunization room) Infrared thermometer Datalogger Fridge tag Freeze tag

36 CTC a disruptive aproach

37 Controlled Temperature Chain - CTC An optional method of transporting and storing vaccines in carriers without icepacks up to specific number of days before the vaccines are used Only for campaign or special strategy setting. Support +40 C for a minimum of 3 days and must have: A vaccine vial monitor (VVM) on each vial, and A peak threshold indicator in each vaccine carrier. The vaccine must be licensed for use in a CTC (WHO PQ and NRA)

38 Why is it useful? Fewer resouces Easier outreach Increased coverage

39 CTC Pilots in Africa Priority vaccines to be used in CTC: - Human papillomavirus (HPV); - Oral cholera vaccine (OCV); - Tetanus toxoid vaccine - Hepatitis B vaccine birth dose (HepB-BD). Already in use in estern, central and subsaarian africa

40 New Technologies and approaches Thank you! Gisele Miranda

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