The First Approved RSV Vaccine Worldwide Belongs to AstraZeneca and Sanofi

The European Commission (EC) is the first regulatory agency worldwide to approve a respiratory syncytial virus (RSV) vaccine. AstraZeneca and Sanofi’s Beyfortus (nirsevimab) won the honor of this historic approval, built on the basis of the pivotal MELODY efficacy trial. The trial demonstrated the vaccine’s efficacy. 

Related Article: GSK’s RSV Vaccine Candidate Has Won Another Regulatory Review

The World’s First RSV Vaccine

RSV is a common virus that leads to infections of the lungs and respiratory tract. These infections are typically mild, although they occur in most people at some point in their life. However, RSV is especially risky for immunocompromised individuals. These risks include the worsening of certain conditions such as chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure. This can lead to pneumonia, hospitalization, and death.

Currently, a number of companies work on RSV vaccine candidates. Earlier this week, GSK announced an FDA acceptance for their vaccine candidate for priority review. Pfizer also has an RSV candidate in development. On November 1, Pfizer published results from a trial, wherein the potential vaccine demonstrated an efficacy of 81.8% against severe medically attended lower respiratory tract illness due to RSV in infants. 

However, AstraZeneca and Sanofi beat out the competition. In the MELODY Phase 3 study, the two companies’ collaborative vaccine, Beyfortus, demonstrated an efficacy of 74.5% against lower respiratory tract infections caused by RSV.

As a result, Beyfortus won the positive recommendation of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This opinion won over the EC, who granted Beyfortus approval in the European Union. 

On the approval, Iskra Reic, Executive Vice President, Vaccines and Immune Therapies of AstraZeneca, said, “Beyfortus is the first single-dose preventative option against respiratory syncytial virus to gain approval in Europe and is also the first and only preventative option approved for a broad infant population. Today’s marketing authorisation of Beyfortus marks a significant achievement for the scientific community and addresses a persistent, global unmet need in RSV prevention.”

This approval marks the first RSV vaccine approval worldwide by any regulatory body. It is very likely that Beyfortus will win approval in other countries based on this announcement.

By Ray Parker

Author

GeneOnline