- Vaccine candidate has the potential to be the first available to help protect adults aged 60 years and older from lower respiratory tract disease caused by respiratory syncytial virus
- Application includes important pivotal phase III data evaluating the efficacy and safety of our vaccine candidate against respiratory syncytial virus-lower respiratory tract disease in adults aged 60 years and above
- Canadian regulatory submission follows regulatory submissions in the US, Europe and Japan
MISSISSAUGA, ON, Nov. 25, 2022 /CNW/ – GSK has filed a New Drug Submission (NDS) to Health Canada for its respiratory syncytial virus (RSV) older adult vaccine candidate. If approved, GSK’s RSV older adult vaccine candidate has the potential to be the first vaccine available to help protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
Canada’s Regulatory filing follows regulatory submission acceptances by the US Food and Drug Administration (FDA), the European Medicines Agency and Japan’s Ministry of…