RSV: UK to examine whether to offer monoclonal antibody routinely to all babies

The UK’s Medicines and Healthcare Products Regulatory Agency has approved nirsevimab, a long acting monoclonal antibody, to protect newborn babies against respiratory syncytial virus (RSV) lower respiratory tract disease. The European Medicines Agency gave its approval earlier this month.1

Approval was based on the results of two studies published in the New England Journal of Medicine showing that nirsevimab has a good safety and efficacy profile in preterm and full term infants.234 One trial in 1490 healthy infants showed that a single injection of nirsevimab, in comparison with placebo, produced a 74.5% reduction in RSV associated lower respiratory tract infections needing medical care.

However, the preventive injection won’t be offered routinely to all babies in the UK until more data are available on whether it prevents hospital admissions for RSV. A new trial, Harmonie, is trying to answer that question.5 This study hopes to recruit more than 20 000 infants up to 12 months in the UK, Germany, and France.

A collaboration between the UK National Institute …