Path

SEE PART III, LINE 1.

THE PROGRAMS & INNOVATION DIVISION BRINGS DEEP TECHNICAL EXPERTISE AND A ROBUST, COLLABORATIVE, AND INTERDISCIPLINARY APPROACH TO SUPPORT PATH COUNTRY PROGRAMS AND PARTNERS IN ADVANCING HEALTH EQUITY. WE FOCUS ON GENERATING ANALYTICAL INSIGHTS, TRANSLATING THEM INTO ADVOCACY AND ACTION, ADVANCING INCLUSIVE AND SUSTAINABLE INNOVATION, AND STRENGTHENING WORKFORCE SKILLS AND RESOURCES THAT SUPPORT INTEGRATED AND RESILIENT HEALTH SYSTEMS. OUR WORK COVERS DIGITAL TRANSFORMATION, PRODUCT DEVELOPMENT, MARKET SHAPING, EPIDEMIC PREPAREDNESS AND RESPONSE, AND MORE.(CONTINUED ON SCHEDULE O)CENTER OF DIGITAL AND DATA EXCELLENCEPATH USES DIGITAL TECHNOLOGIES AND DATA-LED ACTION TO ADVANCE HEALTH EQUITY. IN 2021, PATH'S CENTER OF DIGITAL AND DATA EXCELLENCE CATALYZED COUNTRY-LED DIGITAL HEALTH TRANSFORMATION. FOR EXAMPLE, WORK CONTINUED ON THE DATA USE PARTNERSHIP, A BILL & MELINDA GATES FOUNDATION-FUNDED PROJECT WHERE PATH SUPPORTS THE GOVERNMENT OF TANZANIA TO IMPROVE ITS HEALTH INFORMATION SYSTEMS. THROUGH THIS PROJECT, THE GOVERNMENT ENDORSED A NEW HEALTH ENTERPRISE ARCHITECTURE, AN IMPORTANT STEP TO ENSURE ALIGNMENT OF THE COUNTRY'S DIGITAL SYSTEMS. IN ADDITION, THE PROJECT LAUNCHED AN IMPROVED E-LEARNING PLATFORM THAT STREAMLINES AND STANDARDIZES E-LEARNING MODULES TO MAKE IT EASIER TO TRACK HEALTH WORKER CREDENTIALS AND SCHOOL RECORDS.THE DATA USE ACCELERATION AND LEARNING PROJECT, ALSO FUNDED BY THE GATES FOUNDATION, CAPTURED LEARNINGS FROM FIVE COUNTRIES - BURKINA FASO, ETHIOPIA, MALAWI, SOUTH AFRICA, AND TANZANIA - TO DEVELOP A MODEL FOR DIGITAL TRANSFORMATION FOR DATA USE THAT BUILDS ON EXISTING FRAMEWORKS. THE INFORMATION WILL SUPPORT GOVERNMENTS, IMPLEMENTERS, POLICYMAKERS, AND FUNDERS AS THEY SHIFT THEIR FINANCING, GUIDANCE, AND PROGRAMMATIC APPROACHES TO IMPROVE THE USE OF DATA.BACKED BY A U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT (USAID) INVESTMENT OF UP TO $120 MILLION, DIGITAL SQUARE, A PATH-LED INITIATIVE, CONTINUED TO BRING DONORS AND PARTNERS TOGETHER TO IMPROVE HOW THE GLOBAL COMMUNITY DESIGNS, USES, AND PAYS FOR DIGITAL HEALTH TOOLS AND APPROACHES, WITH AN EMPHASIS ON COUNTRY-DRIVEN PRIORITIES.PATH, WITH U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) FUNDING, IS LEADING THE OVERALL HEALTH INFORMATION SYSTEM SUPPORT COMPONENT OF THE U.S. PRESIDENT'S EMERGENCY PLAN FOR AIDS RELIEF (PEPFAR) TECHNICAL ASSISTANCE PLATFORM THAT PARTNERS WITH COUNTRIES TO SUPPORT THEM IN BUILDING LASTING DIGITAL HEALTH CAPACITY. IN 2021, THE TEAM RECEIVED APPROVAL FOR OUR SECOND-YEAR WORK PLAN AND BUDGET, ENABLING WORK TO BEGIN ON STRENGTHENING HEALTH SYSTEMS FOR HIV AND/OR COVID-19 IN COTE D'IVOIRE, ETHIOPIA, HAITI, KENYA, NAMIBIA, NIGERIA, RWANDA, VIETNAM, AND ZAMBIA.IN 2021, PATH SUPPORTED THE LAUNCH OF THE DIGITAL HEALTH APPLIED LEADERSHIP PROGRAM, A YEAR-LONG TRAINING THAT ENHANCES PARTICIPANTS' CAPACITY TO SUCCESSFULLY LEAD AND EXECUTE DIGITAL HEALTH PROGRAMS. DESIGNED WITH A COMPREHENSIVE LEADERSHIP CURRICULUM FOR A DIVERSE COHORT OF LEARNERS, THE PROGRAM CONSISTS OF CORE ONLINE COURSES, WORKSHOPS, INSTRUCTION FROM TUTORS, AND GUIDANCE FOR PLANNING AND DELIVERING A PROJECT TO BUILD DIGITAL HEALTH CAPACITY ACROSS PARTICIPATING COUNTRIES.PATH CONTINUED TO PARTICIPATE IN HIGH-LEVEL GLOBAL COALITIONS, INCLUDING TRANSFORM HEALTH, WHICH SUPPORTS THE DEVELOPMENT OF HEALTH DATA GOVERNANCE PRINCIPLES; THE LANCET/FINANCIAL TIMES JOINT COMMISSION, WHICH RELEASED ITS REPORT ON GOVERNING HEALTH FUTURES 2030; AND THE DIGITAL CONNECTED CARE COALITION.DIAGNOSTICSPATH'S DIAGNOSTICS PROGRAM AIMS TO ADVANCE AND INCREASE ACCESS TO HIGH-QUALITY AND APPROPRIATE DIAGNOSTICS THAT IMPROVE THE HEALTH OUTCOMES OF PEOPLE AND COMMUNITIES IN LOW-RESOURCE SETTINGS.IN 2021, OUR PIONEERING WORK SUPPORTED THE ADVANCEMENT OF AFFORDABLE, RELIABLE DIAGNOSTICS, PROTEINS, ANTIBODIES, AND TOOLS BY AIDING THE DEVELOPMENT, COMMERCIALIZATION, AND PROCUREMENT OF NEW TECHNOLOGIES; SECURING REGULATORY APPROVAL; CONDUCTING PERFORMANCE EVALUATIONS AND CLINICAL STUDIES TO INFORM PATIENT CARE; AND PUBLISHING 18 PEER-REVIEWED ARTICLES.IN RESPONSE TO THE GLOBAL COVID-19 PANDEMIC, WE SUPPORTED THE DEVELOPMENT AND VALIDATION OF DIAGNOSTIC TOOLS, TECHNOLOGIES, AND SOLUTIONS SUITABLE FOR USE IN LOW- AND MIDDLE-INCOME COUNTRIES (LMICS). THIS INCLUDED DEVELOPING MULTIPLE PUBLICLY AVAILABLE INTERACTIVE COVID-19 DIAGNOSTIC DASHBOARDS TO SUPPORT DATA-DRIVEN PRODUCT SELECTION AND PROCUREMENT DECISIONS; CREATING A COVID-19 SAMPLE REPOSITORY TO SUPPORT DEVELOPERS IN ACCESSING CLINICAL SAMPLES FOR RESEARCH AND DEVELOPMENT; ENSURING THE QUALITY OF COVID-19 RAPID DIAGNOSTIC TESTS WITH A BENCHMARKING PANEL THAT ENABLES UNBIASED, COMPARATIVE EVALUATIONS BETWEEN COVID-19 TESTS; SUPPORTING THE NATIONAL RESPONSE IN BRAZIL, INDONESIA, MALAWI, NEPAL, AND PAKISTAN TO DETECT AND QUANTIFY THE PRESENCE OF SARS-COV-2 IN WASTEWATER; AND CONDUCTING CLINICAL AND OPERATIONAL STUDIES TO ENSURE THAT COVID-19 POINT-OF-CARE TESTS ARE AN EFFECTIVE MEANS OF COMBATTING COVID-19 IN SETTINGS WHERE LABORATORY RESULTS ARE DELAYED OR UNAVAILABLE.IN MAY 2021, THE SD BIOSENSOR STANDARD G6PD TEST RECEIVED REGULATORY APPROVAL FROM THE AUSTRALIAN THERAPEUTIC GOODS ADMINISTRATION (TGA). PATH HELPED GUIDE THE TEST THROUGH PRODUCT DEVELOPMENT AND CLINICAL EVIDENCE GENERATION FOR SUBMISSION TO THE TGA. THIS IS THE FIRST POINT-OF-CARE TEST FOR GLUCOSE-6-PHOSPHATE DEHYDROGENASE (G6PD) DEFICIENCY THAT CAN SUPPORT SAFE ACCESS TO THE CURRENTLY AVAILABLE DRUGS FOR PLASMODIUM VIVAX MALARIA.IN COLLABORATION WITH THE UNIVERSITY OF QUEENSLAND'S PROTEIN EXPRESSION FACILITY, PATH ADVANCED THE COMMERCIALIZATION OF HIGHLY SPECIFIC AND SENSITIVE MALARIA ANTIGEN REAGENTS FOR IMMUNOLOGICAL TESTS. THESE NEWLY AVAILABLE CUSTOM PROTEINS WILL FACILITATE DEVELOPMENT AND PERFORMANCE BENCHMARKING OF RAPID, ACCURATE, SPECIES-SPECIFIC MALARIA DIAGNOSTICS. THE DIAGNOSTICS TEAM CONTINUED TO MANAGE A COMMUNITY OF PRACTICE FOR G6PD OPERATIONAL RESEARCH AND HOSTED SIX INFORMATION-SHARING WEBINARS.IN COLLABORATION WITH THE U.K. NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROLS, PATH WORKED TO DEVELOP AND RELEASE 14 HIGH-QUALITY AND AFFORDABLE MONOCLONAL ANTIBODIES TO SUPPORT DEVELOPMENT OF PNEUMOCOCCAL VACCINES THAT ARE LOW-COST, SEROTYPE-SPECIFIC, AND TAILORED FOR USE BY VACCINE DEVELOPERS AND RESEARCHERS IN LMICS.MEDICAL DEVICES AND HEALTH TECHNOLOGIES THE MEDICAL DEVICES AND HEALTH TECHNOLOGIES PROGRAM IS PATH'S PRODUCT DEVELOPMENT ARM. THE PROGRAM WORKS WITH PUBLIC- AND PRIVATE-SECTOR PARTNERS AROUND THE WORLD TO DEVELOP, TEST, INTRODUCE, AND SCALE UP AFFORDABLE INNOVATIONS TO IMPROVE THE HEALTH OF PEOPLE IN LMICS. FOR EXAMPLE, IN COLLABORATION WITH LOCAL STAKEHOLDERS AND RESEARCHERS, WE DEVELOP FIT-FOR-PURPOSE HEALTH TECHNOLOGIES SUCH AS THE ELLAVI UTERINE BALLOON TAMPONADE (UBT), A LIFESAVING INTERVENTION FOR POSTPARTUM HEMORRHAGE. IN 2021, THE ELLAVI UBT'S AVAILABILITY GREW TO 16 COUNTRIES. THE CAYA DIAPHRAGM, ANOTHER PATH-DEVELOPED MEDICAL DEVICE, ACHIEVED REGULATORY APPROVAL IN 7 LATIN AMERICAN COUNTRIES, BRINGING THE GLOBAL TOTAL TO 39 COUNTRIES WHERE THE DEVICE IS NOW AVAILABLE.PATH CONTINUED TO SUPPORT INCLUSIVE INNOVATION, HIRING ADDITIONAL DESIGN AND INNOVATION SPECIALISTS IN AFRICA, WHICH ALLOWED THE LIVING LABS INITIATIVE TO CO-CREATE WITH APPROXIMATELY 1,000 FRONTLINE HEALTH WORKERS AND COMMUNITY MEMBERS. THE PATH MICROARRAY PATCH CENTER OF EXCELLENCE CONTINUED OUR CROSS-SECTOR WORK TO ADVANCE THIS NEEDLE-FREE DELIVERY TECHNOLOGY PLATFORM FOR MEASLES, RUBELLA, AND COVID-19 VACCINES.FINALLY, WE CONVENED A GLOBAL SYRINGE MANUFACTURER WORKSHOP AND PRODUCED AN AUTODISABLE SYRINGE GAP ANALYSIS MODEL TO INFORM GLOBAL STAKEHOLDERS AND U.S. DECISION-MAKERS. WE ALSO PRODUCED AND SHARED GLOBAL COLD CHAIN MODELING DATA FOR COVID-19 VACCINES ACROSS 92 ADVANCED MARKET COMMITMENT COUNTRIES. TO ADDRESS THE URGENT NEED FOR A COVID-19 VACCINE THAT IS THERMOSTABLE AND NEEDLE-FREE, THE FORMULATION TEAM SUBMITTED A PATENT APPLICATION FOR A FREEZE-DRIED FORMULATION OF AN MRNA VACCINE SUITABLE FOR ORAL AND PARENTERAL ADMINISTRATION.MARKET DYNAMICSPATH'S MARKET DYNAMICS PROGRAM WORKS TO INCREASE EQUITABLE ACCESS TO HEALTH PRODUCTS AND SERVICES BY DIAGNOSING THE ROOT CAUSES OF MARKET FAILURES, DESIGNING APPROPRIATE SOLUTIONS, AND DEVELOPING SUSTAINABLE AND INCLUSIVE HEALTH MARKETS. THIS WORK COMPLEMENTS PATH'S OTHER EFFORTS, SUCH AS PRODUCT DEVELOPMENT/INTRODUCTION AND HEALTH SYSTEMS STRENGTHENING, AND IS DONE IN CLOSE COLLABORATION WITH NATIONAL MINISTRIES OF HEALTH, GLOBAL AGENCIES, COMMERCIAL PARTNERS, AND PATH'S COUNTRY PROGRAMS. IN 2021, OUR LARGEST AREAS OF WORK WERE:

ESSENTIAL MEDICINES: PATH'S ESSENTIAL MEDICINES DIVISION DEVELOPS AND DELIVERS LIFESAVING VACCINES AND DRUGS FOR WOMEN, CHILDREN, AND COMMUNITIES AROUND THE GLOBE.(CONTINUED ON SCHEDULE O)CENTER FOR VACCINE INNOVATION AND ACCESSPATH'S CENTER FOR VACCINE INNOVATION AND ACCESS ALIGNS EXPERTISE ACROSS EVERY STAGE OF VACCINE RESEARCH, DEVELOPMENT, AND INTRODUCTION TO MAKE VACCINES AVAILABLE TO MORE COMMUNITIES, PARTICULARLY IN LMICS. OUR PORTFOLIO INCLUDES MORE THAN TWO DOZEN VACCINE PRODUCTS IN DEVELOPMENT OR ALREADY IN USE, WITH AN EMPHASIS ON THE LEADING INFECTIOUS CAUSES OF CHILD DEATH AND DISEASE WORLDWIDE.IN 2021, PATH CONTINUED TO SUPPORT THE GLOBAL COVID-19 RESPONSE BY PROVIDING EXPERTISE TO THE COVAX FACILITY, SUPPORTING VACCINE SUPPLY CHAIN NETWORKS, PROVIDING TECHNICAL ASSISTANCE AND TRAINING TO VACCINE MANUFACTURERS, STRENGTHENING CLINICAL RESEARCH CENTER AND COUNTRY DELIVERY READINESS, AND TRAINING PHARMACISTS AS VACCINATORS IN GHANA. WE ALSO SUPPORTED THE MRNA VACCINE TECHNOLOGY HUB IN SOUTH AFRICA AND PROVIDED COORDINATION AND TECHNICAL ASSISTANCE FOR A CONSORTIUM DEVELOPING AN EGG-BASED COVID-19 VACCINE FOR PRODUCTION IN BRAZIL, THAILAND, VIETNAM, AND OTHER LMICS. ADDITIONALLY, PATH GUEST EDITED A SPECIAL ISSUE OF VACCINE INSIGHTS ON COVID-19.IN ONGOING EFFORTS TO FACILITATE LOCAL VACCINE PRODUCTION, PATH SUPPORTED VIETNAM-BASED MANUFACTURER POLYVAC TO ESTABLISH A SYSTEM FOR CONDUCTING POST-LICENSURE VACCINE SAFETY SURVEILLANCE AND DATA ANALYSIS. THIS NEW SYSTEM ENSURES POLYVAC'S COMPLIANCE WITH LOCAL AND GLOBAL REGULATORY REQUIREMENTS. PATH ALSO SUPPORTED CHINESE VACCINE MANUFACTURERS TO READY LOCALLY MADE VACCINES FOR THE GLOBAL MARKET, THEREBY INCREASING AVAILABLE INTERVENTIONS AND POTENTIALLY MAKING VACCINES MORE ACCESSIBLE FOR LMICS. WE HELPED LAUNCH A PHASE 3 CLINICAL STUDY IN KENYA OF A YELLOW FEVER VACCINE FROM BEIJING INSTITUTE OF BIOLOGICAL PRODUCTS. DATA FROM THE STUDY WILL SUPPORT AN APPLICATION FOR WHO PREQUALIFICATION (PQ), A KEY STEP FOR GLOBAL AVAILABILITY. WE PROVIDED TECHNICAL ASSISTANCE TO SEVERAL OTHER MANUFACTURERS PREPARING FOR WHO PQ SUBMISSION OR INSPECTION; THUS IN 2021, SINOVAC BIOTECH LTD'S COVID-19 VACCINE, CORONAVAC, RECEIVED EMERGENCY USE LISTING, AND XIAMEN INNOVAX BIOTECH'S HPV VACCINE, CECOLIN, RECEIVED WHO PQ. PATH CONTINUED TO PROVIDE TECHNICAL SUPPORT TO POLIO VACCINE MANUFACTURERS AND ADVANCE RESEARCH ON NEW INACTIVATED POLIO VACCINE AND ORAL POLIO VACCINE CANDIDATES. BASED ON THE REAL-WORLD PERFORMANCE OF A NOVEL ORAL POLIO VACCINE AGAINST TYPE 2 POLIOVIRUS (NOPV2), THE WHO STRATEGIC ADVISORY GROUP OF EXPERTS ON IMMUNIZATION (SAGE) ENDORSED WIDER USE OF NOPV2 UNDER THE EMERGENCY USE LISTING. PATH ALSO LAUNCHED A PHASE 3 STUDY OF NOPV2 AND A PHASE 1 STUDY OF NOPV1.THROUGHOUT THE YEAR, PATH AND OUR PARTNERS EXPANDED COVERAGE OF JAPANESE ENCEPHALITIS (JE) VACCINATION AND DEVELOPED AND DISSEMINATED EVIDENCE TO SUPPORT JE VACCINE DECISION-MAKING. PATH LAUNCHED A NEW STUDY ON THE COST OF ILLNESS FOR JE AND ITS LONG-TERM CONSEQUENCES IN BANGLADESH, LAOS, AND VIETNAM. WE ALSO WORKED CLOSELY WITH THE GOVERNMENT OF BANGLADESH AND LOCAL PARTNERS TO INFORM THE COUNTRY'S JE VACCINATION DECISION-MAKING, WITH AN APPLICATION TO GAVI, THE VACCINE ALLIANCE (GAVI) EXPECTED IN 2022.ALSO IN 2021, WE CONTINUED A PIVOTAL PHASE 3 STUDY OF A POLYVALENT MENINGOCOCCAL MENINGITIS CONJUGATE VACCINE. THIS VACCINE, DEVELOPED BY SERUM INSTITUTE OF INDIA PVT. LTD., BUILDS ON THE SUCCESS OF MENAFRIVAC, A GROUNDBREAKING VACCINE AGAINST SEROGROUP A MENINGOCOCCAL MENINGITIS THAT WAS DEVELOPED THROUGH AN EARLIER PATH PARTNERSHIP. THE POLYVALENT VACCINE TARGETS SEROGROUPS A, C, W, X, AND Y. AS THE FIRST VACCINE TO TARGET SEROGROUP X, THE VACCINE HAS THE POTENTIAL TO ELIMINATE MENINGOCOCCAL MENINGITIS EPIDEMICS FROM AFRICA'S "MENINGITIS BELT" REGION. WE CONTRIBUTED TECHNICAL AND STRATEGIC EXPERTISE TO THE GLOBAL DEFEATING MENINGITIS BY 2030 INITIATIVE AND SUPPORTED THE WHO CELEBRATION AND LAUNCH OF DEFEATING MENINGITIS BY 2030: A GLOBAL ROAD MAP.PATH ACCELERATED THE DEVELOPMENT AND INTRODUCTION OF A WIDE VARIETY OF MALARIA VACCINE CANDIDATES AND APPROACHES. WE CONTINUED TO WORK WITH WHO; THE MINISTRIES OF HEALTH IN GHANA, KENYA, AND MALAWI; AND OTHER PARTNERS TO INTRODUCE THE WORLD'S FIRST MALARIA VACCINE, KNOWN AS RTS,S, IN SELECTED AREAS OF THOSE COUNTRIES. IN 2021, THE VACCINE RECEIVED A RECOMMENDATION FROM WHO FOR BROAD USE TO CURB PLASMODIUM FALCIPARUM MALARIA IN CHILDREN LIVING IN MODERATE-TO-HIGH MALARIA TRANSMISSION AREAS. WE CONTINUED TO ADVANCE RESEARCH INTO WHETHER REDUCING THE DOSE LEVEL OF RTS,S AND DELAYING THE ADMINISTRATION OF DOSES HAS THE POTENTIAL TO STRETCH LIMITED VACCINE SUPPLIES. WE ALSO RESEARCHED USE OF THE VACCINE TO AVERT HIGHLY SEASONAL MALARIA ALONGSIDE SEASONAL MALARIA CHEMOPREVENTION. WE CONTINUED WORK TO IDENTIFY IMMUNE CORRELATES OF PROTECTION AND STUDY THE USE OF MONOCLONAL ANTIBODIES TO PREVENT MALARIA, AND WE CONTINUED WORK ON A FIVE-YEAR CONTRACT FROM USAID TO ADVANCE PRE-ERYTHROCYTIC, BLOOD-STAGE, AND COMBINATION MALARIA VACCINE APPROACHES.THE DEFEAT DIARRHEAL DISEASE (DEFEATDD) INITIATIVE CONTINUED ITS ROLE AS A DIGITAL HUB FOR INFORMATION ON PREVENTING AND TREATING CHILDHOOD DIARRHEAL DISEASE, THE SECOND-LEADING CAUSE OF DEATH AMONG CHILDREN IN LMICS. A MAJOR FOCUS OF 2021 WAS HIGHLIGHTING CLIMATE CHANGE AND GENDER INEQUITY AS MAJOR DRIVERS OF CHILD HEALTH OUTCOMES.TO REDUCE THE BURDEN OF ROTAVIRUS, A MAJOR CAUSE OF SEVERE DIARRHEA, PATH CONTINUED CLINICAL DEVELOPMENT OF AN INJECTABLE NONREPLICATING ROTAVIRUS VACCINE CANDIDATE WITH THE START OF A PHASE 3 EFFICACY STUDY AT THREE CLINICAL SITES IN AFRICA. PATH ALSO BEGAN A PHASE 2 STUDY WITH THIS CANDIDATE IN SOUTH AFRICA TO EXAMINE IMMUNE RESPONSES TO DIFFERENT COMBINATIONS OF ORAL AND INJECTED ROTAVIRUS VACCINES. IN ADDITION, PATH CONTINUED A CASE-CONTROL STUDY IN INDIA TO EVALUATE THE EFFECTIVENESS OF SERUM INSTITUTE OF INDIA PVT. LTD.'S LICENSED ROTAVIRUS VACCINE, ROTASIIL. PATH CONTINUED TO SUPPORT CLINICAL TRIALS AND RESEARCH ON VACCINE CANDIDATES THAT MAY PROVIDE PROTECTION AGAINST ENTEROTOXIGENIC ESCHERICHIA COLI (ETEC) AND SHIGELLA, THE LEADING BACTERIAL CAUSES OF DIARRHEAL ILLNESS. CURRENTLY, THERE ARE NO LICENSED VACCINES AGAINST EITHER PATHOGEN. WE COMPLETED FURTHER ANALYSIS OF RESULTS FROM A PHASE 2B EFFICACY STUDY OF AN ORAL ETEC VACCINE CANDIDATE (ETVAX) IN FINNISH TRAVELERS TO BENIN, WHICH SHOWED ETVAX VACCINATION REDUCED THE NEED FOR ANTIBIOTICS. IN ADDITION, WE COMPLETED IN-DEPTH EXPLORATORY IMMUNOLOGY ANALYSES OF A NOVEL, INJECTABLE SUBUNIT SHIGELLA VACCINE CANDIDATE USING SAMPLES FROM A RECENT PHASE 1 STUDY SUGGESTING EFFECTIVE IMMUNIZATION MAY BE POSSIBLE WITH A SINGLE DOSE.PATH CONTINUED TO ADVANCE PRECLINICAL DEVELOPMENT OF A VACCINE AGAINST GROUP B STREPTOCOCCUS, A LEADING CAUSE OF BACTERIAL SEPSIS AND MENINGITIS IN YOUNG INFANTS WORLDWIDE, AND AGAINST PNEUMOCOCCAL DISEASE, A TOP CAUSE OF DEADLY CHILDHOOD PNEUMONIA. WE SUPPORTED INVENTPRISE AS IT WORKS TO DEVELOP MULTIVALENT CONJUGATE VACCINES FOR BOTH DISEASES THAT WILL BE AFFORDABLE FOR LMICS.AS PART OF THE TYPHOID VACCINE ACCELERATION CONSORTIUM, PATH WORKED TO ADVANCE TYPHOID CONJUGATE VACCINE (TCV) INTRODUCTION IN GAVI-ELIGIBLE COUNTRIES: IN MALAWI AND NEPAL, WE CONTINUED TO SUPPORT EACH GOVERNMENT IN PLANNING FOR TCV INTRODUCTION; IN PAKISTAN, WE SUPPORTED THE GOVERNMENT IN PLANNING FOR THE CONCLUSION OF THE NATIONAL ROLLOUT; IN LIBERIA AND ZIMBABWE, WE WRAPPED UP OUR SUPPORT AFTER SUCCESSFUL TCV INTRODUCTION CAMPAIGNS; AND IN ADDITIONAL COUNTRIES, WE INITIATED DISCUSSIONS TO SUPPORT DECISION-MAKING. WE CONTINUED TO SHARE NEW DATA AND SERVE AS A HUB FOR TYPHOID INFORMATION, RAISING AWARENESS ON TYPHOID DISEASE AND PREVENTION THROUGH AN INTEGRATED APPROACH THAT INCLUDES VACCINES. TO PREVENT CERVICAL CANCER, PATH CONTINUED TO COORDINATE A CONSORTIUM OF NINE INDEPENDENT RESEARCH INSTITUTIONS TO COLLATE, ANALYZE, AND DISSEMINATE EVIDENCE ON SINGLE-DOSE HPV VACCINATION. THIS INCLUDED SYNTHESIZING NEWLY AVAILABLE, CRITICAL CLINICAL TRIAL DATA TO PREPARE FOR AND PRESENT EVIDENCE TO WHO'S SAGE. A SINGLE-DOSE SCHEDULE WOULD HELP ALLEVIATE COUNTRIES' FINANCIAL, LOGISTICAL, OR OTHER BARRIERS TO HPV VACCINE INTRODUCTION. PATH ALSO SPONSORED A PHASE 3 STUDY OF A LICENSED HPV VACCINE IN GHANA AND BANGLADESH TO GENERATE EVIDENCE IN LMICS AND ON EXTENDED DOSING SCHEDULES, AND CONTINUED DATA COLLECTION FOR AN HPV COST-OF-DELIVERY STUDY IN SIX COUNTRIES WITH HPV VACCINATION PROGRAMS.

AFRICA REGION: PATH'S WORK IN AFRICA INTERSECTS VIRTUALLY EVERY PATH GLOBAL PROGRAM, FROM ADVOCACY AND PUBLIC POLICY TO SEXUAL AND REPRODUCTIVE HEALTH. WE HAVE COUNTRY OFFICES IN SEVEN SUB-SAHARAN NATIONS SPANNING CENTRAL, EASTERN, SOUTHERN, AND WESTERN AFRICA: THE DRC, ETHIOPIA, KENYA, SENEGAL, TANZANIA, UGANDA, AND ZAMBIA - WITH PROJECT OFFICES IN SEVEN MORE. HIGHLIGHTS FROM OUR COUNTRY OFFICES INCLUDE:(CONTINUED ON SCHEDULE O)DRCIN 2021, PATH'S ENGAGEMENT IN THE DRC FOCUSED ON HIV/AIDS, VACCINATION (COVID-19 AND POLIO), AND HEALTH SYSTEM STRENGTHENING. FOR EXAMPLE, THE USAID INTEGRATED HIV/AIDS PROJECT, WHICH PATH LEADS IN HAUT-KATANGA PROVINCE (IHAP-HK), ACHIEVED THE INTERNATIONAL GOLD STANDARD RATE OF 95% UNDETECTABLE VIRAL LOAD AMONG A COHORT OF 45,000. PATH ALSO SUPPORTED THE COVID-19 RESPONSE, INCLUDING HOSTING THE PRESIDENTIAL COVID-19 TASK FORCE IN OUR KINSHASA OFFICE, CONDUCTING THE FIRST DRC NATIONWIDE OXYGEN AVAILABILITY ASSESSMENT, AND MONITORING COVID-19 VACCINATION (THE LATTER VIA THE USAID M-RITE PROJECT). PATH SUPPORTED THE DRC PRESIDENT'S OFFICE FOR THE SECOND PRESIDENTIAL IMMUNIZATION AND POLIO ERADICATION FORUM. TO ACCELERATE TWO HIGH-PRIORITY INITIATIVES - THE DIGITAL TRANSFORMATION OF THE COUNTRY'S HEALTH SECTOR AND UNIVERSAL HEALTH COVERAGE - THE MOH, WITH SUPPORT FROM THE DIGITAL SQUARE TEAM WITHIN PATH, LAUNCHED AN INVESTMENT ROAD MAP WITH MORE THAN 60 INSTITUTIONS PARTICIPATING IN PRIORITIZING CATALYTIC INVESTMENTS.ETHIOPIAWITH FUNDING FROM GAVI THROUGH THE TARGETED COUNTRY ASSISTANCE (TCA) PROJECT, PATH SUPPORTED THE AFAR REGION TO PILOT AND IMPLEMENT CATCH-UP IMMUNIZATION IN TWO CONFLICT-AFFECTED AREAS. PATH ALSO SUPPORTED THE MOH TO IMPLEMENT A VACCINATION STRATEGY DESIGNED SPECIFICALLY FOR COVID-19 VACCINE AND HPV VACCINE, CONDUCTING AN INTEGRATED VACCINATION CAMPAIGN NATIONWIDE FOR TWO COHORTS OF ADOLESCENT GIRLS AND YOUNG WOMEN. IN CLOSE COLLABORATION WITH THE MOH, PATH DESIGNED AND WAS AWARDED A PROJECT FROM BIG WIN PHILANTHROPY TO REVAMP AND RESTORE MATERNAL AND CHILD HEALTH PROGRAMS IN CONFLICT-AFFECTED AREAS, WITH A FOCUS ON EARLY CHILDHOOD DEVELOPMENT AND CAREGIVER HEALTH.KENYAPATH'S NONCOMMUNICABLE DISEASES (NCD) TEAM PARTNERED WITH THE KENYA GOVERNMENT TO EVALUATE THE NATIONAL NCD STRATEGY 2015-2020 TO INFORM THE DESIGN AND DEVELOPMENT OF THE NCD STRATEGY 2021-2026. FOLLOWING LAUNCH OF THE STRATEGY IN JULY 2021, PATH SUPPORTED DISSEMINATION TO OUR FOCAL COUNTIES. PATH IS PRIME ON THE PEPFAR-FUNDED USAID NURU YA MTOTO PROJECT, WITH A FIVE-YEAR (2021-2026) BUDGET OF MORE THAN $44 MILLION. THROUGH THIS PROJECT, PATH LEADS A CONSORTIUM THAT PROVIDES HIV SERVICES TO YOUNG PEOPLE IN HOMA BAY, KISII, AND MIGORI COUNTIES. THROUGH THE DREAMS INITIATIVE, WE CONTINUED TO SUPPORT HIV PREVENTION FOR ADOLESCENT GIRLS AND YOUNG WOMEN. WORKING AS A SUBPARTNER, PATH ALSO SUPPORTED BORESHA JAMII, A PEPFAR-FUNDED USAID PROJECT TO INCREASE ACCESS TO AND DEMAND FOR HIGH-QUALITY TB/HIV PREVENTION, CARE, AND TREATMENT.RTS,S, THE WORLD'S FIRST MALARIA VACCINE, WAS DEVELOPED BY GSK OVER MORE THAN 30 YEARS AND IN PARTNERSHIP WITH PATH SINCE 2001. IN OCTOBER 2021, WHO RECOMMENDED EXPANDING USE OF THE VACCINE ACROSS THE AFRICAN CONTINENT. WITH PATH SUPPORT, KENYA, ONE OF THE FIRST COUNTRIES TO GAIN REGULATORY APPROVAL FOR RTS,S, EMBARKED ON A PHASED INTRODUCTION AND EVALUATION TO LEARN HOW BEST TO IMPLEMENT THE VACCINE WITHIN THE CONTEXT OF ROUTINE IMMUNIZATION.THE PATH KENYA LIVING LABS TEAM IN 2021 FINALIZED THE DESIGN AND PILOT TESTING OF A PROTOTYPE DIGITAL TOOL TO SUPPORT SCHEDULING FOR BOTH IMMUNIZATION AND PHC SERVICES. THE TOOL COMPLEMENTS AN IMMUNIZATION DASHBOARD DEVELOPED BY THE LIVING LABS TEAM TO TRACK PERFORMANCE ON KEY INDICATORS ACROSS KENYA'S COUNTIES, SUBCOUNTIES, AND FACILITIES. KENYA IS ONE OF SEVERAL COUNTRIES RECEIVING SUPPORT THROUGH THE COVID-19 RESPIRATORY CARE RESPONSE COORDINATION PROJECT, A CONSORTIUM FUNDED BY THE BILL & MELINDA GATES FOUNDATION. IN 2021, THE CONSORTIUM, LED BY PATH, PROCURED AND INSTALLED RESPIRATORY CARE EQUIPMENT AT 23 HIGH-VOLUME FACILITIES AND ENSURED THE REPAIR/INSTALLATION OF FIVE OXYGEN GENERATION PLANTS AT TERTIARY/REFERRAL HEALTH FACILITIES. ADDITIONALLY, PATH SUPPORTED KENYAN COUNTIES IN CONDUCTING CAPACITY-BUILDING AND SUPPORTIVE SUPERVISION UNDER THE M-RITE PROJECT, WHICH FOCUSES ON IMMUNIZATION.SENEGALPATH PROVIDED TECHNICAL ASSISTANCE AND LOGISTICAL SUPPORT TO THE MOH IN ROLLING OUT THE 3RD EDITION OF THE INTEGRATED DISEASE SURVEILLANCE AND RESPONSE SYSTEM, A KEY TOOL IN IDENTIFYING, MANAGING, AND MITIGATING INFECTIOUS DISEASE OUTBREAKS. RELATED, PATH PROVIDED TECHNICAL ASSISTANCE TO THE DIRECTORATE OF LABORATORIES AND THE MOH IN DEVELOPING AND VALIDATING NATIONAL STANDARD OPERATING PROCEDURES FOR DETECTION AND SURVEILLANCE OF ANTIMICROBIAL RESISTANCE (AMR).PATH SUPPORTED THE GOVERNMENT IN VARIOUS ASPECTS OF ITS COVID-19 RESPONSE, INCLUDING PROCUREMENT OF EQUIPMENT AND REAGENTS FOR DIAGNOSTIC TESTS AS WELL AS INTENSIVE CARE EQUIPMENT FOR TREATMENT OF SEVERE CASES. AT THE COMMUNITY LEVEL, PATH WORKED TO STIMULATE DEMAND FOR COVID-19 VACCINATION.IN 2021, THE TOOLS FOR INTEGRATED MANAGEMENT OF CHILDHOOD ILLNESS (TIMCI) PROJECT LAUNCHED IN SENEGAL, AND THE TRAINING, SUPERVISION, AND COMMUNITY ENGAGEMENT PHASE BEGAN WITH IMPLEMENTATION AT FOUR INTERVENTION SITES. TIMCI (WITH PATH AS LEAD PARTNER) SUPPORTED THE MOH TO REVISE THE COUNTRY'S INTEGRATED MANAGEMENT OF CHILDHOOD ILLNESS GUIDELINES WITH THE SPECIFIC OBJECTIVE OF INCLUDING PULSE OXIMETRY AND OXYGEN THERAPY INDICATIONS. AS PATH'S WESTERN AFRICA HUB, PATH SENEGAL SUPPORTED THE MOH OF GUINEA, A NEIGHBORING COUNTRY, IN INTEGRATING ALL VIRAL HEMORRHAGIC FEVERS, INCLUDING EBOLA, INTO ITS NATIONAL SURVEILLANCE EARLY WARNING SYSTEM. PATH ALSO PROVIDED TECHNICAL ASSISTANCE TO THE GOVERNMENT OF MALI IN THE DIGITALIZATION OF COVID-19 VACCINATION DATA.TANZANIAIN 2021, THE DATA USE PARTNERSHIP, A COLLABORATION BETWEEN PATH AND THE GOVERNMENT OF TANZANIA, LAUNCHED THE AFYA SUPPORTIVE SUPERVISION PLAN TO IMPLEMENT A DIGITAL SYSTEM FOR DATA COLLECTION IN HEALTH FACILITIES. THE PLAN SUPPLIED 900 TABLETS TO NATIONAL- AND REGIONAL-LEVEL USERS, WITH PATH LEVERAGING OUR EXPERTISE TO SUPPORT TRAININGS ON THE EQUIPMENT AND SOFTWARE.ALSO IN TANZANIA, THE INFECTIOUS DISEASE DETECTION AND SURVEILLANCE (IDDS) PROJECT OPERATIONALIZED A NATIONAL AMR SURVEILLANCE FRAMEWORK. HEALTH WORKERS IN THE COUNTRY CAN NOW SUBMIT HIGH-QUALITY AMR DATA PRODUCED THROUGH THIS FRAMEWORK TO THE NATIONAL DATABASE AND THE GLOBAL AMR SURVEILLANCE SYSTEM.IN COLLABORATION WITH THE MOH, PATH LAUNCHED THE TIMCI PROJECT IN THREE DISTRICTS. WORK IN 2021 INCLUDED DEVELOPING, DEPLOYING, AND SUPPORTING IMPLEMENTATION OF AN ELECTRONIC CLINICAL DECISION-SUPPORT ALGORITHM. PATH'S DIGITAL SQUARE INITIATIVE SUPPORTED THE MOH IN IMPLEMENTING A STANDARDS-BASED NATIONAL HEALTH INFORMATION EXCHANGE PLATFORM THAT BY CLOSE OF 2021 ALLOWED FOR EXCHANGE OF DATA BETWEEN 13 DISPARATE HEALTH INFORMATION SYSTEMS. THROUGH GAVI/TCA, PATH SUPPORTED THE MOH TO TRANSITION FROM A TRADITIONAL, PAPER-BASED SYSTEM FOR IMMUNIZATION TRACKING TO FULL ELECTRONIC DATA COLLECTION AND MANAGEMENT IN MORE THAN 600 PHC FACILITIES. SEPARATELY, PATH SUPPORTED THE MOH TO DEVELOP A RESPIRATORY CARE EQUIPMENT BASELINE ASSESSMENT TOOL, MEDICAL OXYGEN TRAINING MANUAL, AND SCALE-UP PLAN.IN LATE 2021, THE HEALTHY HEART AFRICA PROJECT BEGAN IN TANZANIA WITH THE SIGNING OF A MEMORANDUM OF UNDERSTANDING BETWEEN THE MOH AND ASTRAZENECA, AFTER WHICH PATH CONDUCTED A STAKEHOLDER WORKSHOP TO INTRODUCE THE PROJECT AND ENSURE GOVERNMENT COMMITMENT AND ACCOUNTABILITY. UGANDAIN 2021, PATH'S ADVOCACY AND PUBLIC POLICY TEAM IN UGANDA INFLUENCED THE INTRODUCTION OF A SUPPLEMENTARY BUDGET FOR COVID-19 VACCINATION AND ENSURED BUDGET INCREASES FROM PREVIOUS YEARS FOR ROUTINE IMMUNIZATION AND PHC WERE MAINTAINED DESPITE BUDGET SHORTFALLS AT THE NATIONAL LEVEL. PATH SUCCESSFULLY ADVOCATED FOR THE PASSAGE OF A NATIONAL HEALTH INSURANCE SCHEME AND HELPED DEVELOP A UNIVERSAL HEALTH COVERAGE ROAD MAP AND COMMUNITY HEALTH EXTENSION WORKERS STRATEGY IN PILOT DISTRICTS. OUR TEAM ADVOCATED FOR INTEGRATION OF THE ADDIS DECLARATION ON IMMUNIZATION COMMITMENTS INTO EXPANDED PROGRAM ON IMMUNIZATION WORK PLANS BY CREATING AND DISSEMINATING A SCORECARD TOOL TO SERVE AS AN ACCOUNTABILITY FRAMEWORK. PATH IN UGANDA ALSO ADVOCATED FOR PRIORITIZATION OF ROUTINE IMMUNIZATION TO PREVENT BACKSLIDING DURING COVID-19, WITH A FOCUS ON CATCH-UP CAMPAIGNS SUCH AS A NATIONAL POLIO IMMUNIZATION CAMPAIGN. PATH ALSO SUPPORTED THE MOH TO DISSEMINATE GUIDELINES ON THE CONTINUITY OF ESSENTIAL HEALTH SERVICES DURING COVID-19 AT THE SUBNATIONAL LEVEL, REACHING MORE THAN 400 CHAMPIONS AND HEALTH CARE WORKERS THROUGH TECHNICAL WORKSHOPS AND TRAININGS.

ADVOCACY AND PUBLIC POLICYPATH'S ADVOCACY AND PUBLIC POLICY TEAM WORKS IN THE UNITED STATES, IN AFRICA (DRC, KENYA, SOUTH AFRICA, AND UGANDA), AND AT THE GLOBAL LEVEL WITH MULTILATERAL AGENCIES. WE PARTNER WITH POLICYMAKERS TO HELP THEM UNDERSTAND ISSUES AND MOTIVATE THEM TO COMMIT FUNDING, CRAFT POLICIES, AND SPONSOR INITIATIVES TO STRENGTHEN GLOBAL HEALTH. AS A 501(3)C ORGANIZATION, PATH DOES NOT INFLUENCE THE OUTCOMES OF ELECTIONS AND DOES NOT EMPLOY ANY REGISTERED LOBBYISTS. PATH PROVIDES BEHIND-THE-SCENES SUPPORT TO ADVOCACY PARTNERS IN THE PLACES WHERE WE WORK TO HELP STRENGTHEN THEIR CAPACITY TO ENGAGE WITH LOCAL DECISION-MAKERS TO IMPROVE HEALTH IN THEIR COMMUNITIES. WE FACILITATE PEER-TO-PEER LEARNINGS AMONG THESE PARTNERS TO EXCHANGE BEST PRACTICES AND LESSONS LEARNED ABOUT THE PRACTICE OF ADVOCACY, AND WE HELP ELEVATE LOCAL VOICES IN GLOBAL CONVERSATIONS AROUND HEALTH. IN 2021, PATH LED EFFORTS TO ENSURE SUPPORT AMONG OUR PARTNER POLICYMAKERS TO MAINTAIN AND STRENGTHEN PIVOTAL WORK IN GLOBAL HEALTH RESEARCH AND DEVELOPMENT, MATERNAL AND CHILD HEALTH, IMMUNIZATION, PHC, AND PANDEMIC PREPAREDNESS AND RESPONSE. SUCCESSES INCLUDED PROTECTING KEY U.S. GOVERNMENT FUNDING FOR PATH'S PRIORITY HEALTH AREAS AND HELPING DECISION-MAKERS SHAPE THE GLOBAL RESPONSE TO COVID-19.ASIA, MIDDLE EAST, AND EUROPE REGIONPATH'S LEADERSHIP IN THE ASIA, MIDDLE EAST, AND EUROPE (AMEE) REGION LEVERAGES OUR DEEP EXPERTISE ACROSS MULTIPLE HEALTH DISCIPLINES TO CHAMPION EQUITY IN ACCESS TO CARE, INTRODUCE NEW TECHNOLOGIES AND APPROACHES, AND PARTNER ACROSS SECTORS TO PROVIDE HUMAN-CENTERED CARE AND SUPPORT. PATH COORDINATES OUR WORK IN THIS REGION FROM OFFICES IN EIGHT COUNTRIES, INCLUDING OFFICES IN CHINA, INDIA, UKRAINE, AND VIETNAM THAT SERVE AS REGIONAL HUBS FOR TECHNICAL AND SCIENTIFIC INNOVATION. HIGHLIGHTS INCLUDE:IN 2021, PATH CONTINUED TO COLLABORATE CLOSELY WITH STAKEHOLDERS TO DELIVER HIGH-QUALITY HEALTH SERVICES WHILE FORGING NEW PARTNERSHIPS IN COUNTRIES SUCH AS BANGLADESH, INDONESIA, LAOS, AND NEPAL AND EXPLORING COLLABORATIONS IN NEW GEOGRAPHIES IN THE MIDDLE EAST.PATH PREPARED AND RESPONDED TO EMERGING HEALTH THREATS IN THE REGION BY PROVIDING TECHNICAL SUPPORT, ENHANCING LABORATORY CAPACITY, STRENGTHENING RESPIRATORY CARE RESPONSE, IMPROVING THE COVID-19 SURVEILLANCE SYSTEM, AND LEVERAGING OUR NETWORK OF PARTNERS TO SUPPORT PANDEMIC RESPONSE. IN ADDITION TO THE COVID-19 EMERGENCY, WE COMMITTED TO ELIMINATE LONG-NEGLECTED DISEASES SUCH AS LEISHMANIASIS AND ENSURE THAT THOSE INFECTED RECEIVE CARE.THANKS TO OUR CONTINUOUS WORK IN DEVELOPING INNOVATIVE DIGITAL HEALTH TOOLS, PATH WAS ABLE TO MAINTAIN ESSENTIAL HEALTH SERVICES FOR KEY POPULATIONS IN MYANMAR, DIGITIZE THE LACTATION MANAGEMENT SYSTEM IN INDIA, AND SUPPORT MEDICATION ADHERENCE FOR TB PATIENTS IN UKRAINE. THROUGHOUT THE YEAR, AMEE PROGRAMS FOCUSED ON INCREASING HEALTH SYSTEM CAPACITY AND RESILIENCE WITH COMMUNITY-BASED APPROACHES THAT BRING AWARENESS, AVAILABILITY, AND ACCESSIBILITY OF HEALTH SERVICES TO HARD-TO-REACH COMMUNITIES. IN VIETNAM, FOR EXAMPLE, WE IMPLEMENTED A HIGHLY SUCCESSFUL PROGRAM FOR HIV SELF-TESTING. PATH IN THE AMEE REGION ALSO CONTINUED OUR CLOSE COLLABORATION WITH WHO, UNICEF, GAVI, AND THE GLOBAL FUND ON LARGE-SCALE EFFORTS TO CONTROL AND ELIMINATE DEBILITATING DISEASES SUCH AS MALARIA AND MENINGITIS; TO IMPROVE ACCESS TO LIFESAVING VACCINES FOR CERVICAL CANCER, DIARRHEAL DISEASE, AND PNEUMOCOCCAL DISEASE IN LOW-INCOME COUNTRIES; AND TO STRENGTHEN VACCINE MANUFACTURING CAPACITY AND THE COLD CHAIN AS PART OF OUR ONGOING EFFORTS TO BRING HEALTH AND WELL-BEING TO ALL.