GSK’s RSV Vaccine Candidate Has Won Another Regulatory Review

GSK announced on November 2 that the United States Food and Drug Administration (FDA) accepted their Biologics License Application (BLA) for the company’s respiratory syncytial virus (RSV) older adult vaccine candidate. In addition to accepting the BLA, the FDA granted the vaccine candidate, the FDA granted GSK a priority review. 

The basis of the BLA was the positive data gathered from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase 3 trial.

Related Article: GSK Posts Stellar Results from Phase 3 RSV Vaccine Trial

RSV Vaccine Candidate Won Priority Review

RSV is a virus responsible for infections of the lungs and respiratory tract. Though the disease is very common, with mild infection occurring in most people at some point in their life, it is especially risky for individuals with weakened immune systems. Risks associated with RSV infection in at-risk groups 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.

GSK developed a vaccine for the inoculation of RSV in older adults, one of the at-risk groups. The AReSVi-006 Phase 3 trial evaluated GSK’s vaccine candidate, analyzing the overall efficacy against RSV lower respiratory tract disease (LRTD) in adults aged 60 years and older. The trial enrolled over 25,000 participants across 17 different countries. 

The trial found that the vaccine had a “consistent high vaccine efficacy” in addition to a favorable safety profile. The results of the AReSVi-006 Phase 3 trial formed the basis of GSK’s BLA submission to the FDA. 

On November 2, GSK announced that the FDA not only accepted the BLA but granted it priority review as well. The acceptance marks the third major regulatory milestone for the vaccine candidate after similar regulatory acceptances in the European Union and Japan. 

With an action date set for May 3, 2023, GSK’s vaccine candidate has the potential of being the first RSV vaccine for older adults approved anywhere in the world. However, with competition such as Pfizer’s own RSV vaccine, the race is on for the spot as the world’s first RSV vaccine. 

Author

Max Heirich