Tracking Hecolin (HEV239) & Hepatitis E Prevention Strategies
Hepatitis E Virus (HEV) causes 20 million infections annually with 3.3 million symptomatic cases and 44,000 deaths. While typically self-limiting in healthy adults, HEV is devastating in pregnant women (mortality rates up to 30% in third trimester) and immunocompromised individuals. Hecolin (HEV239) is the world's only licensed Hepatitis E vaccine, approved in China in 2012 but not yet available globally. The vaccine showed 100% efficacy in Phase 3 trials and could save thousands of lives if deployed in endemic regions of South Asia and sub-Saharan Africa. WHO has not yet prequalified Hecolin, limiting international use. This tracker monitors Hecolin's expansion, global regulatory progress, and next-generation HEV vaccine candidates targeting pregnant women and travelers to endemic areas.
Developer: Xiamen Innovax Biotech / National Institutes for Food and Drug Control (China)
Platform: Recombinant protein vaccine (truncated HEV capsid protein)
Efficacy: 100% efficacy against symptomatic Hepatitis E in Phase 3 trial (112,604 participants)
Dosing: Three doses at 0, 1, and 6 months
Safety: Excellent safety profile in massive Phase 3 trial. Well-tolerated across all age groups.
Target: Adults aged 16-65, particularly in endemic areas (South Asia, sub-Saharan Africa)
Status: Licensed and used in China since 2012. WHO prequalification pending - major barrier to global deployment.
Impact: Could dramatically reduce maternal mortality if approved for pregnant women (currently contraindicated due to lack of pregnancy safety data).
Developer: International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) / Partners
Platform: Hecolin vaccine tested in pregnant women
Critical Need: Pregnant women have 15-30% mortality rate from HEV in endemic areas (vs. 0.5-3% in general population)
Innovation: First trial specifically evaluating safety and efficacy in pregnancy - the highest-risk group
Status: Phase 3 trials in Bangladesh evaluating Hecolin safety in pregnancy. If successful, could save thousands of maternal lives.
Developer: Multiple groups
Platform: Hecolin or similar recombinant vaccines
Target: Travelers to endemic regions (South Asia, Africa), military deployments, aid workers
Status: Phase 2 trials evaluating abbreviated schedules and immunogenicity in non-endemic populations
Goal: Pre-travel vaccination similar to Hepatitis A vaccine
Developer: Various academic/industry groups
Approaches: mRNA vaccines, VLP vaccines, improved recombinant proteins
Goals: Single-dose formulation, broader genotype coverage, explicit pregnancy safety data
Status: Preclinical and early Phase 2 development
Developer: Academic consortia
Target: Transplant recipients, HIV+ individuals, cancer patients - groups with chronic HEV risk
Challenge: Chronic HEV infection occurs almost exclusively in immunocompromised individuals
Status: Phase 1 safety trials in immunocompromised populations
Hecolin represents an underutilized vaccine success story. With 100% efficacy proven in one of the largest vaccine trials ever conducted (112,604 participants), it could save tens of thousands of lives annually if deployed globally. The primary barriers are: (1) Regulatory: WHO prequalification needed for GAVI/international procurement, (2) Awareness: HEV underrecognized compared to Hepatitis A/B, (3) Pregnancy data: Despite pregnant women being highest risk, no pregnancy safety data exists (ethical barriers to trials), (4) Economic: Limited commercial market outside endemic regions. HEV is particularly deadly in pregnant women - 15-30% mortality vs. 0.5-3% in general population. Endemic hotspots: Bangladesh, India, Pakistan, Egypt, Sudan. Outbreaks occur in refugee camps, conflict zones, floods (fecal-oral transmission). Future priorities: WHO prequalification of Hecolin, pregnancy safety studies, single-dose formulations, integration into routine immunization in hyperendemic areas.