Intradermal (ID) Flu Vaccine Available Now For The First Time In The UK

Main Category: Immune System / Vaccines
Also Included In: Flu / Cold / SARS;  Public Health
Article Date: 07 Sep 2010 - 0:00 PDT

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Reliable intradermal (ID) flu vaccination1, amplifying the immune response of older vulnerable people, will help to protect them from flu and its complications during this year's flu season.2,3,4,5 Available now in the UK, the Intanza®15µg micro-needle injection system* is simple for healthcare practitioners to use, with a narrow (30G), short (1.5mm) needle that is nearly imperceptible for patients.3

In clinical trials, Intanza®15µg generated a higher immune response than standard intramuscular (IM) flu vaccine in adults aged 60 years and over 4,5 and is licensed for use in this age group. In general Intanza®15µg is well tolerated. The incidence of injection-site reactions was higher for the ID than the IM vaccine but these reactions were generally mild and of short duration.4,5,6 The frequency of systemic reactions† showed no significant differences between ID and IM vaccines.4,5,6

Standard intramuscular (IM) flu vaccine gives 70-80% protection7 but 1 in 3 older patients may remain at-risk of flu infection despite vaccination. This is because the immune function declines with age (immunosenescence)[i] leaving people more susceptible to infection and less responsive to vaccination.9 ID vaccination amplifies the immune response, targeting the high concentration of specialised immune cells located near the dense lymphatic and blood capillary network2,3 in the dermal skin layer‡.

A randomised controlled trial compared ID and IM flu vaccination in 1,107 volunteers aged 60-85 years. Geometric mean titres (GMT) were 48-70% higher in ID vaccine recipients indicating that Intanza®15µg is more immunogenic than standard IM flu vaccine in this age group.4 In a three-year randomised controlled trial in 3,707 adults aged 60-95 years receiving ID or IM flu vaccine, seroprotection rates (GMT≥40 l/dil) were 5-7% higher in the ID group.5 This means that for every 1,000 people vaccinated with Intanza®15µg, an additional 50-70 older people could achieve antibody levels considered protective against flu infection.

The Chief Medical Officer is encouraging healthcare professionals to increase flu vaccine coverage in the over 65 year-old at-risk group, currently 72.4%, toward the WHO target of 75%. The expectation is that coverage in the clinical at-risk groups, currently 51.6%, will reach 60% by 2011/12.10

When surveyed, people responded positively about ID vaccination. In a survey in Germany and France, 60 to 68% of unvaccinated people covered by national flu vaccination recommendations[1] stated that having the option of intradermal influenza vaccination would encourage them to get vaccinated against influenza.11 In another trial, 96% of participants declared they were satisfied with the micro-needle injection system after being vaccinated.9 **

* Developed in collaboration with Becton Dickinson

† most commonly headache, myalgia and malaise

‡ The dermal skin layer, also called the dermis, is the second layer of the skin just lying beneath the epidermis

§ n=451

** 60-64 years old, n=2262, a validated, self administered, patient reported outcome questionnaire was completed 21 days after intradermal or intramuscular vaccination.

Notes

Indication of Intanza®

Intanza®15µg/strain suspension for injection [Influenza vaccine (split virion, inactivated)] is indicated for the prophylaxis of influenza in individuals 60 years of age and over. For more information on Intanza® including safety profile, please refer to the Summary of Product Characteristics.12 Sanofi Pasteur MSD is progressively launching Intanza® throughout Western Europe††.

Influenza and its complications place a significant annual burden on the NHS

The number of people who consult their GP with influenza-like symptoms varies from year to year, but is usually between 50 and 200 for every 100,000 people per week during the influenza season.13 Patients in the risk groups and those over 65 years of age are more likely to become seriously ill with influenza, perhaps suffering from severe bronchitis or pneumonia. They may be hospitalised more often and have a higher fatality rate.7,14 Even in winters when the incidence of influenza is low, 3,000 to 4,000 deaths have been attributed to it and in epidemic years this number reached almost 30,000.7

Influenza places a high cost burden on the NHS due to secondary care costs such as hospital admissions. Each year in England alone, there are approximately 9,000 excess respiratory admissions in those aged 65 years and over. The average of 9,000 people a year disguises the impact of influenza in a bad year such as 1996/97, when 21,000 excess admissions occurred. Each unplanned patient hospitalisation due to influenza costs the NHS between £347 & £774.15

An average of 9,000 admissions for respiratory infections among people over 65 years of age may not sound excessive but it is likely to mean about 90,000 bed days even in an average year. 14

†† Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom

* The monovalent H1N1swine influenza vaccine is still being offered to this group if they have not received it already as the response to the trivalent seasonal influenza vaccine is uncertain in this age group.

^ The monovalent H1N1swine influenza vaccine is still being offered to these groups if they have not received it already as the immune response to a single dose of trivalent seasonal influenza vaccine would be expected to be suboptimal in immunocompromised individuals that have not previously received the H1N1 swine influenza vaccine.

Further information about seasonal flu vaccination can be found in Chapter 19 (updated) of the 'Green Book'.

About the studies

Randomised controlled clinical studies showing that Intanza® 15µg produces a superior immunogenicity compared with standard intramuscular (IM) flu vaccine in elderly adults involved nearly 5,000 subjects.4,5

The survey of general practitioners and patients on their perception of an intradermal seasonal influenza vaccine and willingness to be vaccinated was carried out in France and Germany in 2009. It involved more than 2,500 subjects who were provided with a set of information (presentation of the micro-needle injection system, intradermal administration, immunogenicity and safety of the vaccine) as part of the survey method.

[1] n=451

References

1. Laurent PE et al. Evaluation of the clinical performance of a new intradermal vaccine administration technique and associated delivery system. Vaccine 2007;25:8833-42

2. Nicolas JF, Guy B. Intradermal, epidermal and transcutaneous vaccination: from immunology to clinical practice. Expert Rev Vaccines 2008;7:1201-14

3. Lambert PH, Laurent PE. Intradermal vaccine delivery: will new delivery systems transform vaccine administration? Vaccine 2008;26:3197-3208 p3205-3199

4. Holland D et al. Intradermal Influenza Vaccine Administered Using a New Microinjection System Produces Superior Immunogenicity in Elderly Adults: A Randomized Controlled Trial. J Infect Dis 2008;198: 650-8

5. Arnou R et al. Intradermal influenza vaccine for older adults: A randomized controlled multicenter phase III study. Vaccine 2009;27:7304-7312

6. Van Damme P, et al. Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study. BMC Infectious Diseases 2010; 10:134

7. Department of Health. Immunisation against infectious disease (Green Book) 2006. TSO

8. Kovaiou RD et al. Age-related changes in immunity : implications for vaccination in the elderly. Expert Rev Mol Med 2007;9:1-17

9. Reygrobellet C et al. Perception and acceptance of intradermal influenza vaccination: Patient reported outcomes from phase 3 clinical trials. Hum Vaccin 26-4-2010;6:336-345

10. Chief Medical Officer letter : 28 May 2010. (last accessed 18 August 2010)

11. Prebet et al., Survey of French and German public and general practitioners on their perception of an intradermal seasonal influenza vaccine and willingness to be vaccinated. 16th WONCA Europe conference 2010; : 1 -

12. Intanza® 15µg, Summary of Product Characteristics, 2010.

13. NHS Choices. Seasonal influenza accessed June 2010

14. Fleming DM. The contribution of influenza to combined acute respiratory infections, hospital admissions, and deaths in winter. Commun Dis Public Health 2000; 3: 32-8.

15. NHS Reference Costs 2008/2009, UK Department of Health (England and Wales). accessed June 2010

Source:
Sanofi Pasteur MSD

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