On the heels of winning an EU nod for its RSV vaccine marketing authorization application, GSK (LSE/NYSE:GSK) has announced that FDA has accepted a Biologics License Application for its RSV vaccine candidate for older adults.
The agency also granted priority review to the vaccine, which will clip four months off the vaccine candidate’s biologics license application (BLA) review time.
The PDUFA date for the vaccine candidate is May 3, 2023.
GSK said that its RSV vaccine, if approved, would be the first to protect adults 60 and over from RSV infections, which can lead to pneumonia, hospitalization and death.
While researchers have sought to develop RSV vaccines since the 1960s, no vaccine against the virus is currently available.
In granting the BLA, FDA reviewed data from a prespecified interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) Phase 3 study.
Experts have warned that there could be a ‘tripledemic’ threat this winter season thanks to the risk of COVID-19, flu and RSV infections. The potential availability of one or more RSV vaccines by fall 2023 could help protect infants, young children and older people from the latter virus, which can be life-threatening in some cases.
In GSK’s clinical study involving adults 60 and older, the vaccine offered strong protection across the RSV A and B strains.
The company has announced the regulatory authorities in Europe and Japan have accepted regulatory submissions for the RSV vaccine.
The latest clinical trial data could indicate the GSK’s RSV vaccine candidate is more effective than Pfizer’s, according to the Financial Times. Although comparing results from disparate clinical trials is problematic, there was a substantial difference in the margin of protection in the GSK and Pfizer studies. GSK’s vaccine candidate had 82.6% overall efficacy, while Pfizer’s vaccine had an overall efficacy of 66.7%.
Despite the positive news, GSK shares dipped about 1% to $33.12.
Filed Under: clinical trials, Drug Discovery, Infectious Disease