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Hepatitis E virus (HEV) subunit vaccines, including HEV 239, demonstrated high protection and safety in primates. Further policy and advocacy are needed for global introduction of this cost-effective HEV vaccine.

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Area of Science:

  • Virology
  • Vaccinology
  • Public Health

Background:

  • Hepatitis E virus (HEV) was molecularly cloned in 1991.
  • Recombinant viral capsid antigens were developed as vaccine candidates.
  • Nonhuman primates were used to test vaccine efficacy against HEV infection and liver disease.

Purpose of the Study:

  • To evaluate the protective efficacy and safety of two genotype 1 HEV subunit vaccine candidates.
  • To assess the potential for widespread adoption and cost-effectiveness of HEV vaccines.

Main Methods:

  • Expression of recombinant HEV capsid antigens in insect cells (56 kDa vaccine) and *Escherichia coli* (HEV 239 vaccine).
  • Testing of vaccine candidates in nonhuman primates for protection against HEV.
  • Review of clinical development, regulatory approval, and public health impact.

Main Results:

  • Both subunit vaccine candidates showed high protective efficacy against hepatitis E.
  • The vaccines were found to be acceptably safe in preclinical studies.
  • The HEV 239 vaccine received approval in China in 2011.

Conclusions:

  • Subunit vaccines are effective against hepatitis E, offering a promising public health tool.
  • Despite demonstrated efficacy and partial approval, WHO prequalification is pending for broader global access.
  • Policymaking, advocacy, and pilot introductions are crucial for implementing HEV vaccines in high-burden regions, where they are expected to be cost-effective.