The Medicines and Healthcare products Regulatory Agency (MHRA) has given a fast-track approval to a high dose flu vaccine, which is designed to be effective in over 65-age group.
The Trivalent Influenza Vaccine (Split Virion, Inactivated) High Dose (TIV High Dose) by Sanofi Pasteur became available to the UK public in 2019/20 flu season as MHRA approved the drug in just seven months.
The decision follows the Department of Health and Social Care (DHSC) and the Joint Committee on Vaccination and Immunisation (JCVI) proposal to make available such vaccines to the public as soon as possible.
According to MHRA, the new vaccine is more effective in older people than the standard flu vaccine and the UK is the only European country where it is approved.
Dr Siu Ping Lam, MHRA’s Licensing Director, said: “This is further evidence of the MHRA’s ability to deliver in an agile and flexible way, and enhances our standing as a world-leading, innovative regulator, to enable time-critical preventative medicines to be available earlier and timely for the protection of our patients.”
TIV High Dose is one of three newer vaccines that JCVI is recommending for use in the over-65 group.
Hugo Fry, Sanofi UK Country Chair & General Manager of Sanofi Pasteur, said: “It’s exciting to see the MHRA increasingly thinking creatively on how to be a fast, balanced, light-touch yet scientifically robust regulator in order to create and capitalise on opportunities for faster product approvals.
“The accelerated approval of our TIV High Dose influenza vaccine is a great example of this and clearly demonstrates their agility, flexibility and willingness to collaborate with industry”.