HEVrokotteen

HEVrokotteen is a vaccine designed to prevent infection with the hepatitis E virus (HEV) in humans. It is a recombinant subunit vaccine intended to provoke an immune response that neutralizes HEV.

The formulation targets the HEV capsid protein to stimulate antibody production. Development has involved international collaborations and several multicenter trials across regions with varying HEV exposure risk.

Clinical development has included phase II and phase III studies in adults and adolescents, reporting high seroconversion rates and a generally favorable safety profile. Efficacy estimates in different populations have been consistent enough to support regulatory submissions in some jurisdictions.

Administration typically involves a two-dose schedule given a few weeks apart; alternative schedules have been evaluated. The vaccine has demonstrated durable immune responses for at least year(s) after vaccination in trials.

Regulatory status varies by country. Some jurisdictions have granted approvals or conditional approvals, while others require additional data before authorization.

Indications and use: It is intended for individuals at risk of HEV exposure, such as travelers to HEV-endemic regions, people in HEV outbreaks, and certain immunocompromised groups. It is not currently recommended for routine vaccination of the general population in many settings.

Safety: Reported adverse events are typically mild or moderate, including injection-site pain, fatigue, and low-grade fever. Serious adverse events are rare, and no new safety signals have emerged in available data.

Storage and handling: The vaccine requires standard refrigerated storage and has a defined shelf-life to maintain potency.