Sanofi UK marketing authorisation granted for Sanofi Pasteur’s Trivalent Influenza Vaccine (Split Virion, Inactivated) High...
21 Enero 2019 - 11:32AM
Sanofi UK marketing authorisation granted for Sanofi Pasteur’s
Trivalent Influenza Vaccine (Split Virion, Inactivated) High
Dose▼(TIV High Dose)
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Press Release Source: Sanofi (EURONEXT: SAN)
(NASDAQ: SNY) |
UK marketing authorisation granted for Sanofi Pasteur’s
Trivalent Influenza Vaccine (Split Virion, Inactivated) High
Dose▼(TIV High Dose)
- TIV High Dose is approved for the prevention of influenza in
people 65 years of age and older,1 a population that is
particularly vulnerable to influenza infection and its
complications2
- National approval process for TIV High Dose could serve as a
template for how new product approvals could take place after the
UK leaves the European Union
- UK is the only European country where TIV High Dose is
approved
MAIDENHEAD, UK – January 18,
2019 – UK marketing authorisation has been granted for
Sanofi Pasteur’s Trivalent Influenza Vaccine (Split Virion,
Inactivated) High Dose (TIV High Dose), which is indicated for
active immunisation of people 65 years of age and older against
influenza disease.1 This decision means the UK is the only European
country where TIV High Dose is approved.
The UK approval of TIV High Dose followed a
national procedure, with 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. “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. “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.” Our immune defenses naturally decline with
advancing age, which can cause our immune responses to vaccines to
diminish.2 This natural decline also means that older adults are
particularly vulnerable to influenza infection and its
complications.2 TIV High Dose has therefore been designed
specifically to improve protection against influenza compared to
standard dose TIV for this population.1
TIV High Dose is included in the Joint Committee
on Vaccination and Immunisation (JCVI) advice on influenza vaccines
for the 2019/20 influenza season.
TIV High Dose is already approved for people 65
years of age and older in the United States (US), Canada, Australia
and Brazil.
About influenza
Influenza or “flu” is an acute viral infection
caused by influenza viruses, which spreads easily from person to
person. Flu circulates all year round worldwide but mostly in the
winter, which is why it’s sometimes referred to as seasonal flu.3
People at highest risk of severe illness or complications from flu
are pregnant women, children under 59 months, the elderly,
individuals with chronic health conditions (such as diabetes, or
chronic heart or respiratory diseases), and individuals that have a
weakened immune system due to conditions such as HIV/AIDS,
malignancy or from receiving chemotherapy or steroids.3 Worldwide,
annual flu epidemics result in 3 to 5 million cases of severe
illness, and 290,000 to 650,000 deaths.3 In industrialised
countries most deaths associated with flu occur among people age 65
or older.3
In the UK, fatalities attributable to flu are
estimated to range from around 4,000 to 14,000 per year, with an
average of around 8,000 fatalities per year, across all age
groups.4 The 2017/18 winter season showed moderate to high levels
of circulating flu in the UK, of which the impact was predominantly
seen in older adults, with a consistent pattern of outbreaks in
care homes.5 Of the 3,454 confirmed, flu-related hospital
admissions to intensive care or high-dependency units, 42% of the
cases were in those aged 65 years and older.5 In addition to
considerable evidence of immune responses to vaccination declining
with age, over 50% of older people (65 years of age and older) have
at least two chronic conditions.6 This further increases the
likelihood of flu-related complications or worsening of the
underlying chronic condition in this population.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions. With
more than 100,000 people in 100 countries, Sanofi is transforming
scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life |
Media Relations Contact Emily Wyer Tel.: +44
(0)7740 410 878 Emily.Wyer@sanofi.com |
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References
1 Trivalent Influenza Vaccine (Split Virion, Inactivated) High
Dose▼ Summary of Product Characteristics 18/01/2019.
2 Haq K et al. (2014) Immunosenescence: influenza vaccination
and the elderly. Curr Opin Immunol. 29C:38-42.
3 World Health Organization. (2018). Influenza (Seasonal).
[Online] Available
at: http://www.who.int/mediacentre/factsheets/fs211/en [Last
accessed December 2018].
4 National Institute for Health and Care Excellence (2018). Flu
vaccination: increasing uptake. Available at:
http://www.nice.org.uk/guidance/ng103 [Last accessed December
2018].
5 Public Health England. Surveillance of influenza and other
respiratory viruses in the UK: Winter 2017 to 2018. Available at:
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/740606/Surveillance_of_influenza_and_other_respiratory_viruses_in_the_UK_2017_to_2018.pdf
[Last accessed December 2018].
6 Kingston A, et al. Projections of multi-morbidity in the older
population in England to 2035: estimates from thePopulation Ageing
and Care Simulation (PACSim) model. Age Ageing.
2018;47(3):374-380.
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