The race to tap the respiratory syncytial virus (RSV) this season intensifies as Sanofi SA (NASDAQ:SNY) and AstraZeneca Plc (NASDAQ:AZN) have revealed data from a real-world trial of their candidate nirsevimab, a long-acting antibody.
In November, nirsevimab was approved in Europe, dubbed Beyfortus, to prevent RSV-LRTD in newborns and infants during their first RSV season.
The phase 3 HARMONIE study recruited over 8,000 infants 12 months and younger. Infants who received a single dose of the antibody were 83% less likely to be hospitalized than those who were not inoculated.
The trial, conducted at 250 sites in France, Germany, and the U.K., took place in the 2022-23 RSV season.
"This winter saw higher rates of RSV-related infant hospitalizations than during pandemic or pre-pandemic years," Thomas Triomphe, the vaccines chief at Sanofi, said in a release. "The HARMONIE data demonstrate the real-world impact nirsevimab has on pediatric hospitalizations."
Data also showed that nirsevimab reduced hospitalizations due to severe RSV-related lower respiratory tract disease (LRTD) by 75.71%. Patients with LRTD have an oxygen level below 90% and require supplementation.
Additionally, nirsevimab demonstrated a reduction of 58.04% in the incidence of all-cause LRTD hospitalization compared to infants who received no RSV inoculation.
Last week, GSK plc (NASDAQ: GSK) became the first company to win FDA approval for an RSV vaccine for adults 60 and older.
Analysts say the market is estimated to be over $5 billion and could exceed $10 billion by 2030.
Nirsevimab is currently undergoing regulatory review in the U.S.
Price Action: SNY shares are up 0.50% at $54.64 on the last check Friday.
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
