AstraZeneca’s Nirsevimab: US FDA Wants Input On How It Would Fit With Pediatric RSV Vaccines
Proposed RSV prevention treatment for infants and neonates showed efficacy with few safety concerns, but with pediatric vaccines in development, FDA wants the Antimicrobial Drugs Advisory Committee to discuss what data would be needed to determine appropriate use in vaccinated infants and mothers.
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Phase II studies of vaccines involve more variables than for drugs and these can be compounded by seasonality. This can make the time until vaccine approval longer than would be expected for drugs.
Maternal vaccines may cause first RSV infections to occur when infants are older, requiring increased study of disease patterns and additional dosing data on AstraZeneca/Sanofi’s nirsevimab in older babies.
A CDC work group seems to be leaning towards recommending choosing either Pfizer’s maternal vaccination for infant RSV or AstraZeneca/Sanofi’s preventative antibody treatment in babies but not both, in part due to the high costs. What happens to the already available Synagis antibody is another wildcard.