PPC: For a zika virus disease vaccine for endemic use

Preferred Product Characteristics for a Zika vaccine for endemic use

21 August 2019
Indication
Prevention of Zika virus-associated serious complications, in particular congenital Zika syndrome.

Target population
Girls and boys below the reproductive age (e.g. <age of 9 years, although girls and women of child-bearing potential could also be considered in catch-up programmes. For non-replicating platforms, alternative age groups could be considered such as during early adolescence.

Efficacy
Demonstration of prevention of virologically confirmed ZIKV illness, in accordance with proposed WHO/PAHO definition ideally in 80% of the population or higher. Acceptable thresholds for efficacy should be informed by updated vaccine impact models, and by market research with key stakeholders. Evidence of prevention of ZIKV infection would be desired, in addition to demonstration of prevention of ZIKV illness. Surrogate of immunity markers obtained from animal models, human challenge studies or cohort studies can be considered.
Safety
Safety and reactogenicity at least comparable to WHO-recommended routine vaccines, providing a highly favourable risk-benefit profile, ideally with only mild, transient adverse events related to vaccination and no serious AEs related to vaccination. Low risk of high fever.
URL
https://www.who.int/publications/m/item/preferred-product-characteristics-for-a-zika-vaccine-for-endemic-use
Product type
Vaccine
Status
Active
Safety

Formulation/presentation: Vaccine is provided as a liquid product in monodose or multi-dose (5-10) presentations with a maximal dosage volume of 0.5mL for i.m. or s.c. administration. Multi-dose presentations should be formulated, managed, and discarded in compliance with WHO’s multi-dose vial policy. Dose regimen: Single-dose primary series is the preferred vaccine characteristics, potentially with a booster dose. Route of administration: Injectable (IM or SC) using standard volumes for injection. Other routes could also be considered such as skin patches. Durability of protection: Confers long-lasting protection predicted to be more than 10 year after administering the primary series and can be maintained by a single booster dose. Stability and storage: Shelf life of at least 12 months at -20°C. and Shelf life of at least 6 months at 2-8°C or above. The need for a preservative is determined and any issues are addressed. VVM: Proof of feasibility and intent to apply a vaccine vial monitor (VVM) to the primary container.

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