What is Intanza?
Intanza is a vaccine available in suspension for injection in pre-filled syringes. Contains fractions of influenza viruses that have been inactivated (killed). Intanza contains three different strains (types) of influenza virus (ie A / New Caledonia / 20/99, A / Wisconsin / 67/2005 and B / Malaysia / 2506/2004).
What is Intanza used for?
Intanza is used for vaccination against adult flu, particularly those with a greater risk of developing complications of the disease. The vaccine should be used according to official recommendations. Adults up to the age of 59 are given the lowest concentration (containing 9 micrograms of each viral strain). People aged 60 or over are given the highest concentration (containing 15 micrograms of each viral strain).
The vaccine can only be obtained with a prescription.
How is Intanza used?
Intanza is administered as an "intradermal" injection into the surface layer of the skin using a special microinjection system. The recommended site of administration is the shoulder.
How does Intanza work?
Intanza is a vaccine. Vaccines act by "teaching" the immune system (the body's natural defense system) to defend itself against a disease. Intanza contains fragments of three different strains of the influenza virus. When a person is vaccinated, the immune system recognizes the fragments of the virus as "foreign" and produces antibodies against that virus. In the event of exposure to any of these virus strains in the future, the immune system will be able to produce antibodies more quickly. Antibodies will help the body protect itself against diseases caused by these influenza virus strains.
Each year, the World Health Organization (WHO) provides recommendations on which flu strains should be included in vaccines for the next flu season. These viral strains will need to be incorporated into Intanza before the vaccine can be used. Intanza currently contains fragments of the viral strains that are expected to cause influenza in the 2006/2007 season, in accordance with WHO recommendations for the northern hemisphere and the European Union (EU). The viral strains contained in Intanza must be replaced again,
before the vaccine can be used in subsequent seasons.
What studies have been carried out on Intanza?
The Intanza effects were first analyzed in experimental models before being studied in humans.
Four studies involving over 8, 000 people were carried out to analyze the effectiveness of Intanza as a protection against influenza. In two of the studies, persons aged less than 60 years vaccinated with a concentration of 9 micrograms were observed. In the other two studies, persons aged 60 or over vaccinated with a concentration of 15 micrograms were observed. In all of the studies, Intanza was compared to another influenza vaccine given by intramuscular injection. The studies compared the ability of the two vaccines to trigger the production of antibodies (immunogenicity), comparing antibody levels before injection and after three weeks.
What benefit has Intanza shown during the studies?
In all the studies, both Intanza and the comparator vaccine reported adequate levels of antibodies for protection against all three influenza strains. In adults under the age of 60, the concentration of 9 micrograms guaranteed a level of protection equal to that of the intramuscular vaccine. In adults aged 60 or over, the concentration of 15 micrograms guaranteed a level of protection equal to that of the intramuscular vaccine.
What is the risk associated with Intanza?
The most common side effects seen with Intanza (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), malaise and local reactions at the point of vaccination (redness, swelling, hardening of the skin, pain and itching) . For the full list of all side effects reported with Intanza, see the Package Leaflet.
Intanza should not be used in people who may be hypersensitive to the active ingredients, to any of the substances, to eggs, to chicken proteins, to neomycin (an antibiotic), to formaldehyde (a preservative) or to octoxinol 9 (a detergent ). People with fever or an acute infection (of short duration) cannot receive the vaccine until complete recovery.
Why has Intanza been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Intanza's benefits outweigh its risks for prophylaxis of influenza in adults up to the age of 59 and aged 60 or over, particularly in the subjects with a greater risk of developing associated complications. The committee recommended the issuing of marketing authorization for Intanza.
More information on Intanza
On 24 February 2009, the European Commission issued a marketing authorization for Intanza, valid throughout the European Union, to Sanofi Pasteur MSD SNC.
For the full version of Intanza EPAR click here.
Last update of this summary: 02-2009.
