GACVS Reviewed Safety Profiles of Hecolin® on its 30th Meeting in Geneva, Switzerland

The Global Advisory Committee on Vaccine Safety (GACVS) held its 30th meeting in Geneva, Switzerland on June 11-12, 2014. The committee reviewed the safety profiles of the Hepatitis E vaccine Hecolin? in the meeting and concluded that the safety data on Hecolin? were reassuring.

The available safety data on Hecolin? derived from Phase 1, 2 and 3 clinical trials in healthy subjects were reviewed and positively approved. As recommendations for further study, GACVS noted that there are no safety data in paediatric subjects (<16 years of age), the elderly (>65 years of age), persons with underlying diseases or conditions such as those who are immunosuppressed persons or have liver disease and thus recommended that studies be conducted to assess the safety of Hecolin? in these subpopulations.

As for safety assessment in pregnant women, GACVS recommended that any follow-up of those inadvertently vaccinated in pregnancy during a HPV Clinical III study, which uses Hecolin? as an active control arm, should be useful to assess safety in this group.

The committee also noted that there are as yet no studies to evaluate the safety and immunogenicity of Hecolin? when given concomitantly with other vaccines. In addition, GACVS recommended that a Phase 4 post-marketing study be conducted once the vaccine is in more widespread use to further assess the safety profile of Hecolin?, in particular with regard to serious and rare adverse events.

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