Vaccine Cold Chain in a Continental Country Brazil GISELE MIRANDA 2018 FLY PHARMA US 11 SEP 2018
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
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
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
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 10 19 3 doses 2 nd Booster Single dose Booster every 10 years years 20 59 years 3 doses Single dose Booster every 10 years 60+ 3 doses Single dose Booster every 10 years Booster every year Pregnant 3 doses 2 doses Single dose
Why is it a big challenge?
Continental country: 8.516.000 km² (US 9.834.000 km²) 5.570 districts 208.7K inhabitants (US 325,7 milhões)
Road infrastructure: 1.720.756 km roads only 12,3% are paved roads
More than 36.000 immunization facilities
Large urban áreas (São Paulo 12.1 million 7th bigger city of the world) X Rural areas (15% in isolated areas)
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
A long way to reach one child A journey to an Amazonian village
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
Temperature sensitivity of vaccines
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
Bio-Manguinhos (vaccine manufacturer)
CENADI (Vaccine s National Storage and Distribution Center)
Special cold box design
Sub-national central stores
Going to the last mile
Support from the Brazilian Army
Immunization room - routine
Outreach immunization National Immunization day
Open markets Schools Beaches Parks Churches...
Never loose the opportunity to vaccinate
How to ensure the quality of the service? Right product Right quantity Right condition Right place Right time Right cost
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
Preparing the dose Handling the vacines How to administer MDVP Never loose the opportunity to vaccinate
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
CTC a disruptive aproach
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)
Why is it useful? Fewer resouces Easier outreach Increased coverage
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
New Technologies and approaches Thank you! Gisele Miranda Gisa@bio.fiocruz.br