UK marketing authorisation has been granted for Sanofi Pasteur’s Trivalent Influenza Vaccine High Dose for people 65 years and older.
As a population that is particularly vulnerable to influenza infection and its complications this is a welcome decision, as it means the UK is the only European country where Trivalent Influenza Vaccine (TIV) High Dose is approved.
“We are pleased that a UK marketing authorisation has been granted for this vaccine. This approval is a positive step towards increasing the options available for healthcare professionals to help protect people 65 years of age and older against flu in the UK,” says Hugo Fry, managing director at Sanofi UK.
He continued, “Sanofi Pasteur is dedicated to supporting public health needs and continues to actively explore several innovative influenza vaccines for the future. We have worked closely with the UK regulator throughout this approval process and are grateful to them for their engaged and agile approach.”
Sanofi Pasteur working in collaboration with the UK regulator in an agile and flexible way to gain accelerated assessment of the dossier. The process took just seven months, compared with a standard review time of 12 months for national approvals. This way of working could provide opportunities for faster product approvals after the UK leaves the European Union.
The treatment is already approved for people 65 years of age and older in the US, Canada, Australia and Brazil.