Sanofi, AstraZeneca Release Real-World Data For Respiratory Syncytial Virus Antibody

The race to tap the respiratory syncytial virus (RSV) this season intensifies as Sanofi SA SNY and AstraZeneca Plc 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 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.