UK Rapidly Approves Influenza Vaccine For Seniors
Sanofi Pasteur TIV High-Dose influenza vaccine is available in the UK for the 2019 2020 flu season
An application for an influenza vaccine designed to be effective in the over-65 age group was quickly approved by UK authorities to become available for the 2019 to 2020 flu season.
Announced on February 19, 2020, by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Sanofi Pasteur was granted a UK license for Trivalent Influenza Vaccine (Split Virion, Inactivated) High Dose (TIV High Dose).
The UK is the only European country where the TIV High-Dose vaccine is approved.
This approval process took just 7 months to complete, compared with a standard review time of 12 months for national approvals.
The MHRA’s Licensing Director, Dr. Siu Ping Lam, said in a statement: “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”.
Influenza vaccines are known to be less effective in the over-65 age group since the immune system is less vigorous in older people, said this press statement. Advancements have been made in flu vaccine technology which can enhance the vaccines’ protective effect in this age range, compared to those which are known to be effective in the under-65s.
Most flu vaccines are made to a specific formula. Due to the desire to enhance its effect in older people, this formula has been optimized for the over-65 age group, resulting in a product that is more effective in older people than the standard flu vaccine.
The Department of Health and Social Care and the Joint Committee on Vaccination and Immunisation (JCVI) in the UK expressed a desire that such vaccines be made available to the UK public as soon as possible, and preferably in time for the 2019 to 2020 flu season.
Hugo Fry, Sanofi UK Country Chair & General Manager of Sanofi Pasteur said: “It’s exciting to see the MHRA increasingly thinking creatively.”
“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”.
In the UK, fatalities attributable to influenza average 8,000 fatalities per year, across all age groups. Of the 3,454 confirmed, flu-related hospital admissions to intensive care or high-dependency units during the 2017/18 winter season, 42 percent of the cases were in those aged 65 years and older.
In addition to the considerable evidence of immune responses to vaccination declining with age, over 50 percent of 65+ years of age have at least 2 chronic conditions. This further increases the likelihood of flu-related complications or worsening of the underlying chronic condition in this population, said this UK statement.
As of February 17, 2020, the WHO reported influenza activity continued to increase across the European region, though it appeared to have already peaked in some countries, with Influenza A detections predominated in most of the reporting countries.
In Ireland, influenza activity continued to decrease but remained above the baseline threshold. And in the United Kingdom of Great Britain and Northern Ireland, influenza activity and illness indicators continued to decrease and were reported at baseline levels.
Influenza Vaccine news published by Precision Vaccinations.
- Sanofi UK marketing authorisation granted for Sanofi Pasteur’s Trivalent Influenza Vaccine (Split Virion, Inactivated) High Dose
- WHO 17 February 2020 - Update number 361, based on data up to 02 February 2020
- Innovation: MHRA’s speedy approval of high dose flu vaccine demonstrates flexibility in national applications