Path Vaccine Solutions

SEE PART III, LINE 1.

IN 2020, PVS CONTINUED OUR FIGHT AGAINST DIARRHEAL DISEASES, THE SECOND-LEADING CAUSE OF DEATH AMONG CHILDREN IN LOW-INCOME COUNTRIES. TO COMBAT ROTAVIRUS, A MAJOR CAUSE OF SEVERE DIARRHEA, WE CONTINUED CLINICAL DEVELOPMENT OF A NONREPLICATING ROTAVIRUS VACCINE CANDIDATE. THE PHASE 3 EFFICACY STUDY THAT BEGAN IN LATE 2019 WAS PAUSED THROUGHOUT 2020 DUE TO THE COVID-19 PANDEMIC IN ORDER TO BEST PROTECT THE HEALTH AND SAFETY OF PARTICIPATING INFANTS AND THEIR FAMILIES. PREPARATORY ACTIVITIES CONTINUED AT THE THREE CLINICAL SITES IN AFRICA THROUGHOUT THE YEAR TO ENSURE READINESS TO RESTART THE TRIAL ONCE CONDITIONS ALLOW. (CONTINUED ON SCHEDULE O).THIS VACCINE CANDIDATE IS ADMINISTERED AS AN INTRAMUSCULAR INJECTION AND COULD POTENTIALLY OVERCOME THE LOWER EFFICACY LEVELS SEEN IN LOW-RESOURCE SETTINGS FOR ORAL, LIVE ATTENUATED ROTAVIRUS VACCINES. IN ADDITION, PVS CONTINUED CONDUCTING A CASE-CONTROL STUDY IN INDIA TO EVALUATE THE EFFECTIVENESS OF SERUM INSTITUTE OF INDIA PVT. LTD.'S (SIIPL'S) LICENSED ROTAVIRUS VACCINE, ROTASIIL. THE STUDY WAS PAUSED FROM LATE MARCH 2020 TO LATE NOVEMBER 2020 DUE TO THE COVID-19 PANDEMIC.PVS 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. IN 2020, OUR WORK INCLUDED COMPLETING THE SUBMISSION OF RESULTS FROM A PHASE 1 TRIAL OF AN INJECTABLE, SUBUNIT ETEC VACCINE CANDIDATE TO THE US FOOD AND DRUG ADMINISTRATION. PVS ALSO PARTIALLY SUPPORTED THE FINAL DATA ANALYSIS FOR A PHASE 2B EFFICACY STUDY OF AN ORAL ETEC VACCINE CANDIDATE IN FINNISH TRAVELERS TO BENIN, REPORTING RESULTS IN MARCH 2020.ACHIEVING WORLD HEALTH ORGANIZATION PREQUALIFICATION IN 2019 FOR PNEUMOSIL (A LOW-COST PNEUMOCOCCAL CONJUGATE VACCINE [PCV] DEVELOPED BY PVS AND SIIPL) TRIGGERED A UNICEF AND SIIPL SUPPLY AGREEMENT IN 2020, WHICH AT $2.00 PER DOSE WAS MORE THAN 30 PERCENT LESS EXPENSIVE THAN OTHER PCVS, IMPROVING AFFORDABILITY FOR LOW- AND MIDDLE-INCOME COUNTRIES. IN ADDITION, PNEUMOSIL RECEIVED MARKET AUTHORIZATION IN INDIA, AND A PHASE 3 CLINICAL TRIAL OF PNEUMOSIL IN THE GAMBIA ALSO PROGRESSED.PVS ADDED TO THE RESPIRATORY SYNCYTIAL VIRUS (RSV) MATERNAL IMMUNIZATION KNOWLEDGE BASE IN 2020. WE PUBLISHED SEVERAL ARTICLES ABOUT THE ECONOMIC IMPACT IN LOW-INCOME COUNTRIES OF RSV AND OTHER ACUTE RESPIRATORY INFECTIONS AMONG INFANTS, AS WELL AS A MODELING EXERCISE ON THE IMPACT OF A HYPOTHETICAL MATERNAL RSV VACCINE IN PROTECTING INFANTS IN COUNTRIES SUPPORTED BY GAVI, THE VACCINE ALLIANCE.PVS ALSO CONTRIBUTED AN ARTICLE ON ANTENATAL CARE TIMING, WHICH COULD INFORM MATERNAL VACCINE COVERAGE, AND A STATE-OF-THE-ART REVIEW ON THE MATERNAL IMMUNIZATION LANDSCAPE. ADDITIONALLY, WE UPDATED OUR RSV VACCINE AND MONOCLONAL ANTIBODY SNAPSHOT (WHICH PROVIDES AN OVERVIEW OF THE INTERVENTION PRODUCT LANDSCAPE) AND TRIAL TRACKER (WHICH PROVIDES INFORMATION ON RELATED CLINICAL TRIALS).