Global Phase 3 Clinical Trial Results Show Nirsevimab Significantly Protects Infants Against Respiratory Syncytial Virus Infection

On March 3, 2022, the international authoritative medical journal "New England Journal of Medicine" today published the detailed results of the phase III clinical trial of the prophylactic monoclonal antibody nirsevimab, which is the first single injection to treat all infants throughout the respiratory tract.

The investigators also conducted a prespecified pooled analysis of respiratory syncytial virus-induced hospitalizations in the Phase III and Phase IIb trials and found that nirsevimab at the recommended dose in term and preterm infants (greater than 28 weeks of gestation) The effective rate in reducing the incidence of RSV-related hospitalization was 77.

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Based on the results of Phase III and Phase II/III clinical trials and Phase IIb clinical trials, nirsevimab has been confirmed to provide sustained protection for all infants throughout the RSV season with only one injection

Jean-François Toussaint, global head of vaccine research and development at Sanofi, said: "In these three pivotal late-stage clinical trials, we are focusing on providing all infants with a first-in-class protection against respiratory syncytial virus

Promising rapid protection Nirsevimab is the first investigational long-acting antibody designed to protect all infants from infection during the first respiratory syncytial virus season and aims to provide rapid and immediate protection to infants with a single dose of nirsevimab immunization

Professor Shen Kunling, consultant of the National Clinical Research Center for Respiratory Diseases, Beijing Children's Hospital affiliated to Capital Medical University and Shenzhen Children's Hospital, said that respiratory syncytial virus is highly contagious, similar to the new coronavirus, and all infants and young children are at risk of infection

It is reported that the prophylactic monoclonal antibody nirsevimab has been clinically studied in more than 30 countries around the world

Sanofi Vaccines and its partner AstraZeneca are working with all parties to jointly promote the development and launch of nirsevimab in China, and protect millions of Chinese babies from respiratory syncytial virus

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