PPC: For enterotoxigenic Escherichia coli (ETEC) vaccines

WHO preferred product characteristics for vaccines against enterotoxigenic Escherichia coli

31 May 2021
Indication
Prevention of moderate-to-severe diarrhoea (MSD) due to ETEC infection.

Target population
Infants from 6 months and children up to 24 months of age. Longer-term effectiveness data in children up to 5 years of age will be of interest for decision-making.
Efficacy
Efficacy of 60% (point estimate) or more against moderate-to-severe ETEC diarrhoea. Assessment of field efficacy in response to all circulating serotypes would inform vaccine effectiveness.
Safety
A safety and reactogenicity profile at least as favourable as current WHO recommended routine vaccines in the comparable age group.
URL
https://www.who.int/publications/i/item/who-preferred-product-characteristics-for-vaccines-against-enterotoxigenic-escherichia-coli
Product type
Vaccine
Status
Active
Safety

Formulation/presentation: Low-dose vials or blow-fill-seal multi-mono- dose containers to reduce missed opportunities for vaccination and vaccine wastage. Dose regimen: At least two doses are expected to be needed for primary immunization, between the ages of 6 and 9 months. An additional booster dose may be required to maintain effective, long lasting immunity through the first 5 years of age. Route of administration:  Oral or injectable (IM, ID or SC), using standard volumes for injection, as specified in programmatic suitability for prequalification (PQ), or needle-free delivery. Durability of protection: Protection to at least 2 years of age starting 14 days after the last dose in the primary series, with protection up to age 5 years desirable. Stability and storage: Two years at 2 to 8°C. For a powder formulation, vaccine vial monitor (VVM) for at least 30 days at 37°C. For a liquid formulation, VVM for at least 14 days at 37°C.

ID_254