A vaccine s journey: the many steps to saving lives

Transcription

1 A vaccine s journey: the many steps to saving lives GW-USAID Mini-University 7 March 2014 Endale Beyene, MA, MPH Rebecca Fields, MPH Angela Shen, ScD, MPH

2 Outline I. What is the problem and where are we today? II. Where does the process begin? III. What is the story behind immunization IV. Looking forward to the future

3 The Decade of Vaccines (DoV): Ambitious Worldwide Goals by 2020

4 Disease burden I. WHAT IS THE PROBLEM AND WHERE ARE WE TODAY?

5 Comparison of 20 th Century Annual Morbidity and Current Morbidity: Vaccine-Preventable Diseases (US) Disease 20th Century 2011 Annual Morbidity Reported Cases Percent Decrease Smallpox 29, % Diphtheria 21, % Measles 530, > 99% Mumps 162, > 99% Pertussis 200,752 15,216 92% Polio (paralytic) 16, % Rubella 47,745 4 > 99% Congenital Rubella Syndrome % Tetanus % Haemophilus influenzae 20,000 8* > 99% Source: JAMA. 2007;298(18): Source: CDC. MMWR January 6, 2012;60(51); (provisional 2011 data) * Haemophilus influenzae type b (Hib) < 5 years of age. An additional 14 cases of Hib are estimated to have occurred among the 237 reports of Hi (< 5 years of age) with unknown serotype.

6 Vaccine Enterprise II. WHERE DOES THE PROCESS BEGIN?

7 A Vaccine s Journey Upstream Processes Downstream processes Discovery / Pre-clinical Development Clinical Trials Licensure / WHO Pre- Qualification Manufacturing Procurement Vaccine Delivery Service Delivery People Donors, Technical Agencies, Manufactures, National Immunization Program and Health System

8 Regulatory Pathway Phase I, II, III NRA/WHO* Phase IV Pre-licensure Licensure and Market Authorization Post-Licensure

9 Case study example: snapshot Burden of disease unpredictable major epidemics in sub-saharan Africa Vaccine strategy Global collaboration led by WHO and PATH, with funding from BMGF, USAID and others Public health goal to eliminate group A meningitis epidemics in sub-saharan Africa over a period of a decade

10 Meningitis belt in Sub-Saharan Africa Over 90 percent of global meningococcal disease occurs in the African meningitis belt One strain (Group A Nm) accounts for estimated 80% of all meningococcal cases Focal epidemics occur every year Major epidemics occur every 7-14 years

11 Problems for vaccines aimed at developing country problems Development of new vaccines are largely controlled by multinationals and aimed at products with market potential Very slow introduction of new products to developing countries (15-20 years) Hepatitis B vaccine HiB conjugate vaccine

12 Creation of the Meningitis Vaccine Project (MVP) The terrible meningitis epidemic in 1996 led African public health officials to ask WHO to help them address this problem. Under WHO leadership international meetings in 2000 and 2001 recommended that new and more potent conjugate meningococcal vaccines be developed for Africa. In June 2001 MVP was created with Gates Foundation support as a 10 year partnership between WHO and PATH. Goal: to eliminate epidemic meningitis in Africa as a public health problem through the development, testing, licensure, and widespread use of conjugate meningococcal vaccines

13 Understanding the problem: Key discussions with African public health officials and WHO/AFRO, Fall 01-Spring 02 Epidemics of Group A meningitis were still occurring Reactive vaccination campaigns were expensive and logistically difficult Dire need for a new and more potent preventive vaccines Conditions that would define any new meningitis vaccine: Cost of vaccine was the most important limiting factor to the introduction of new vaccines in Africa Widespread use of a new conjugate meningococcal vaccine in mass campaigns would not be sustainable unless vaccines were priced less than $US 0.50 per dose (US prices for meningococcal vaccines at > $100/dose)

14 A decision point in 2002: How to develop the Men A conjugate vaccine? MVP could not reach agreement with major vaccine manufacturers. Target price at <$US 0.50 per dose was problematic MVP chose to become a virtual company and to develop its own Group A meningococcal conjugate vaccine Three key problems: Source of vaccine grade raw materials (PS and protein) Manufacturing partner willing to work within a restrictive price point Access to intellectual property for a conjugation method

15 Licensure and Prequalification of MenAfriVac MenAfriVac licensed by Drugs Controller General of India in December WHO prequalification awarded in June 2010.

16 Reported meningitis cases with percent distribution of serogroup A meningococci Burkina Faso, Year Meningitis Cases % Men A , , , , , , Introduction of MenAfriVac in December , , (wk 25) 2,

17 Why did MenAfriVac have such a powerful effect? Ideal timing + a potent vaccine + high coverage In Burkina Faso Group A immunity was elevated in light of the magnitude of the epidemic. MenAfriVac is very immunogenic. Very high coverage rates across 70% of the population were quickly achieved.

18 Access of MenAfriVac to countries in meningitis belt Vaccine Year available in USA Year first introduced in Developing country Lag period: time from USA to introduction in developing country (years) Scale up: Number of years to 25 million doses used in developing countries Lag period for scale up: years from developing country intro to 25 million doses HepB yrs HiB yrs MenA 2005 A/C/Y/W * 2010 N/A A * Age indication inappropriate for Africa

19 Immunization delivery system III. WHAT IS THE STORY BEHIND IMMUNIZATION COVERAGE

20 Co-financing New Vaccines $200 $180 $160 $140 $120 Millions $100 $80 $60 $40 $20 $

21 A Vaccine s Journey Upstream Processes Discovery / Pre-clinical Development Clinical Trials Licensure / WHO Pre- Qualification Manufacturing Donors, Technical Agencies, Manufactures, Downstream processes Procurement Vaccine Delivery Service Delivery People National Immunization Program and Health System

22 A program requires many components Policies -Source: BASICS, 1997 Practices Cold Chain, Supplies, & Logistics Management Training Financing Supportive Supervision Advocacy & Communications Community Action Monitoring & Surveillance

23 Vaccine Journey: Vaccines and Supplies Management (Vaccine Delivery) What? Vaccines and Supplies Estimation Supply Chain Management Cold Chain Stock Management

24 Vaccine Delivery: Estimation of Vaccine and Supplies: Three Methods 1. Based on Target Population 2. Based on Previous Estimation 3. Based on number and type of sessions

25 Vaccine Delivery: Supply Chain Management Distribution and Transportation Push or Pull System Primary Vaccine Stores cold or freezer rooms, freezers, refrigerators, cold boxes, and sometimes refrigerator trucks for transportation. Intermediate Vaccine Stores depending on their size/capacity, need cold and freezer rooms, and/or freezers, refrigerators, and cold boxes. Health Facilities need refrigerators with freezing compartments, cold boxes and vaccine carriers. The suggested maximum length of storage is 6 12 months at national level, 3 months at provincial level, 1 3 months at district level and 1 month or less at health-facility level.

26 Vaccine Delivery: Vaccines are Temperature Sensitive Vaccines are sensitive to heat and freezing and must be kept at the correct temperature from the time they are manufactured until they are used. The system used for keeping and distributing vaccines in good condition is called the cold chain. The cold chain consists of a series of storage and transport links, all designed to keep vaccines within an acceptable range until it reaches the user.

27 Vaccine Delivery: Equipment and Temp Monitoring Devices Refrigerators Cold Box Vaccine Carrier Icepack Thermometers Temperature Monitoring Chart Fridge Tag (New)

28 Vaccine Delivery: Temperature Monitoring VVM WHO advocates the use of new time-temperature devices for continuous temperature recording. In the absence of such devices, thermometer and temperature monitoring chart are used A vaccine vial monitor (VVM) is a label that changes color when the vaccine vial has been exposed to heat over a period of time.

29 Vaccine Delivery: Stock Management Stock management ensures record of vaccines received, and vaccines dispatched or used. This will make sure that vaccines are used before their expiry date that the status of VVM is recorded at receipt and issue that there are no stockouts, or over-stocking wastage rates are estimated Simple Stock Management Methods at Health Facility Stock Management Form

30 Vaccine Journey: Service Delivery What? Planning Implementation Monitoring and Surveillance Supervision The Reaching Every District/Community Approach

31 Service Delivery: Planning Vaccination National level Set policies and standards for Immunization Services Subnational Level Manage the implementation of immunization Policies and standards Service Delivery Level Provide Immunization Services The three vaccination strategies Fixed or Static Outreach Mobile Example of Planning at Service Delivery Level Health Facilities Enhancing Vaccination Coverage Campaigns Vaccination Weeks

32 Service Delivery: Education and Promotion of Immunization Communication Strategies in Immunization Advocacy Social Mobilization Program Communication Community Education Communication methods in immunization Inter Personal Communication Group Communication Radio TV Print materials Eg Poster Posters

33 Service Delivery: Vaccine Administration Vaccine administration Fixed Session Outreach Session

34 Service Delivery: Recording and Reporting Performances Sample Tally Sheet Sample Register Sample Vaccination Card Sample Summary Reporting Form

35 Service Delivery: Vaccination Performance Monitoring Coverage monitoring Chart Conduct Defaulter Tracking 1. Reviewing Immunization Register 1. Using Reminder cards Monitoring chart should be updated VPD Surveillance AEFI Surveillance detecting, monitoring and responding to adverse events following immunization (AEFI)

36 Service Delivery: Conduct Supportive Supervision Supportive supervision is helping to make things work, rather than checking to see what is wrong.

37 Service Delivery: Reaching Every District/Community Strategy Was developed and introduced in 2002 by WHO, UNICEF Has five operational components RED strategy is a strategy to guide immunization programs, not a separate initiative or program. 1. re-establishment of outreach services 2. supportive supervision 3. community links with service deliver 4. monitoring and use of data for action 5. planning and management of resources.

38 A Vaccine s Journey Upstream Processes Downstream processes Discovery / Pre-clinical Development Clinical Trials Licensure / WHO Pre- Qualification Manufacturing Procurement Vaccine Delivery Service Delivery People Donors, Technical Agencies, Manufactures, National Immunization Program and Health System

39 The journey of a vaccine: People Which people? Those who are to receive vaccines (target groups) Those who do receive vaccines Those who do not receive vaccines Those who manage and provide vaccination services Those who influence whether vaccination happens

40 People: Those who are to receive the vaccines (target groups) ARISE GAVI GAVI Wn.com Infants Young children (e.g., measles 2 nd dose) Preadolescents (HPV) Women of child-bearing age (tetanus toxoid) Expanded age groups during campaigns (e.g., polio, measles, meningitis A) Age groups

41 People: who is getting vaccinated? In poorest countries, DTP3 is stagnant and lower, at 73-75% since 2008

42 People: Who is not getting vaccinated? (by WHO Regions)

43 Benin 2011/12 Cote d'ivoire 2012 DRC 2007 Ghana 2008 Guinea Liberia 2007 Madagascar 2008/09 Mozambique 2011 Niger 2012 Nigeria 2008 Rwanda 2010 Senegal 2010/11 Tanzania 2010 Uganda 2011 People: Who is not getting vaccinated? The poor DTP3 coverage for lowest and highest wealth quintiles, DHS surveys in 14 African countries, % 28% 33% 46% 53% 52% 59% 62% 65% 73% 77% 84% 76% 74% 75% 74% 86% 84% 84% 87% 93% 88% 88% 92% 93% 99% 96% 0% 20% 40% 60% 80% 100% 120% 96% Highest quintile Lowest quintile

44 People: WHY are children not fully vaccinated? Epidemiology of the unimmunized child studies Left-outs difficult access, inconvenient hours, negative beliefs/rumors, minority status Drop-outs poor treatment/bad experiences missed opportunities fears (side effects, abuse due to lost vaccination card) poor understanding of need to return or when to return Terms like access and vaccine hesitancy oversimplify the issue. Instead, ask: Are services available, acceptable, affordable, and affable? 44

45 People: Those who provide and manage vaccination services Health care providers District health teams (>4000 in Africa alone)

46 Caretakers and families Community leaders District civil and health authorities Members of Parliament, lawmakers and others who make funding allocation decisions Donors and global partners People: Those who influence whether vaccination happens

47 Discussion IV. LOOKING FORWARD TO THE FUTURE / QUESTIONS

48 Thank you Some resources: