PPC: For human respiratory syncytial virus infections (RSV) monoclonal antibodies
WHO preferred product characteristics of monoclonal antibodies for passive immunization against respiratory syncytial virus (RSV) disease
8 June 2021
Indication
Prevention of severe RSV disease during early infancy, the period of highest risk of severe RSV disease and mortality.
Target population
All infants in the first 6 months of life.
Efficacy
At least 70% efficacy against RSV-confirmed severe disease for five months following administration (the median length of the RSV season).
Safety
Safety and reactogenicity comparable to other WHO recommended vaccines given at the same age (e.g. HepB birth dose).
Product type
Vaccine
Status
Active
Safety
Dose regimen: A one-dose regimen is highly preferred. A single dose can be given as a birth dose or at any healthcare visit during the first 6 months of life. Route of administration: Single intramuscular or subcutaneous dose using standard volumes for injection, as specified in programmatic suitability for prequalification.
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