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| Press release Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)
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United Kingdom marketing authorization for Sanofi Pasteur trivalent influenza vaccine (Split Virion, inactivated) at high dose▼ (VIV High Dose)
- VIV High Dose is approved for the prevention of influenza in people 65 years and older,1 a population particularly vulnerable to influenza infection and its complications2
- The national VIV High Dose approval process could serve as a model for approving new products after the UK's departure from the European Union.
- The United Kingdom is the only European country where TIV High Dose is approved
MAIDENHEAD, UK – 18 January 2019 – A marketing authorization was granted for the trivalent trivalent vaccine Sanofi Pasteur (Split Virion, Inactivated) (VIV High Dose), indicated for the active immunization of persons 65 years of age and older against influenza.1 This decision means that the United Kingdom is the only European country where TIV High Dose is approved.
The UK approval of TIV High Dose was done according to a national procedure. Sanofi Pasteur collaborated with the UK regulator in an agile and flexible way to obtain an accelerated badessment of the case. The process only took seven months, compared to a standard 12-month review period for national approvals. This way of working could offer opportunities for faster approval of products after the UK leaves the European Union.
"We are delighted that a UK marketing authorization has been granted for this vaccine. This approval marks a positive step in increasing the options available to healthcare professionals to help protect people aged 65 and over from the flu in the UK, "said Hugo Fry, General Manager of Sanofi UK. "Sanofi Pasteur is committed to meeting public health needs and continues to actively explore several innovative influenza vaccines for the future. We have worked closely with the UK supervisory authorities throughout this approval process and are grateful for their committed and agile approach. "
Our immune defenses naturally decrease with age, which can lead to a decrease in our immune response to vaccines.2 This natural decline also means that the elderly are particularly vulnerable to influenza infection and its complications.2 The high-dose TIV was therefore specifically designed to improve protection against influenza compared to standard-dose TIV for this population.1
VIV High Dose is included in the opinions of the Joint Committee on Immunization and Vaccination (JCVI) regarding influenza vaccines for the 2019/20 influenza season.
VIV High Dose is already approved for people 65 years of age and older in the United States, Canada, Australia and Brazil.
About the flu
Influenza or "flu" is an acute viral infection caused by an influenza virus that is easily transmitted from one person to another. Influenza circulates all year around the world, but especially in winter, which is why it is sometimes called seasonal flu.3 People most at risk of serious illness or flu complications are pregnant women, children under 59 months of age, the elderly, people with chronic diseases (such as diabetes, heart disease or respiratory diseases). chronic) and the immune system weakened. like HIV / AIDS, a malignant tumor, chemotherapy or steroids.3 Around the world, annual influenza epidemics result in 3 to 5 million cases of serious illness and death from 290,000 to 650,000 people.3 In industrialized countries, most influenza-related deaths occur in people aged 65 and over.3
In the United Kingdom, it is estimated that the number of deaths from influenza varies between 4,000 and 14,000 per year, with an average of about 8,000 deaths per year, all age groups combined.4 The winter season 2017/18 showed moderate to high levels of circulating influenza in the UK, the impact of which was mainly observed in the elderly, with a constant trend of outbreaks in healthcare facilities .5 Of the 3,454 influenza-related hospitalizations confirmed in intensive care units or high-dependence units, 42% involved people aged 65 and over.5 In addition to considerable evidence of decreased immune response to vaccination with age, more than 50% of seniors (65 years and older) have at least two chronic conditions.6 This further increases the risk of complications related to influenza or worsening of the underlying chronic condition in this population.
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About Sanofi Sanofi is committed to helping people meet their health challenges. We are a global biopharmaceutical company focused on human health. We prevent diseases through vaccines, provide innovative treatments to fight pain and relieve suffering. We support the rare people with rare diseases and the millions of people with chronic diseases in the long term. With more than 100,000 people in 100 countries, Sanofi turns scientific innovation into healthcare solutions around the world. Sanofi, empowering life |
References
1 Trivalent influenza vaccine (split virion, inactivated) at high dose ▼ Summary of Product Characteristics 18/01/2019.
2 Haq K et al. (2014) Immunosenescence: influenza immunization 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/fr [Last accessed December 2018].
4 National Institute for the Excellence of Health and Care (2018). Vaccination against the flu: increasing absorption. Available at: http: // www.nice.org.uk/guidance/ng103 [Last accessed December 2018].
5 Public health in England. Surveillance of influenza and other respiratory viruses in the United Kingdom: winter 2017 to 2018. Available at: https://badets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/740606/Surveillance_of_influenza_et_autres_virus_piratoires_spiratoires_in_the_UK_2017_to_188.pdf [Last accessed December 2018].
6 Kingston A et al. Multi-morbidity projections in the elderly in England up to 2035: estimates from
Simulation Model of Population Aging and Care (PACSim). Aging 2018; 47 (3): 374-380.
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