Intanza

influenza vaccine (split virion, inactivated)

This is a summary of the European public assessment report (EPAR) for Intanza. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Intanza.

What is Intanza?

Intanza is a vaccine, which is available as a suspension for injection in a pre‑filled syringe. The vaccine contains fragments of influenza (flu) viruses that have been inactivated (killed). Intanza contains three different strains (types) of influenza virus (A/California/7/2009 (H1N1)-derived strain, A/Perth/16/2009 (H3N2)-like strain and B/Brisbane/60/2008).

What is Intanza used for?

Intanza is used to vaccinate adults against flu, especially those who are at an increased risk of developing complications of the disease. The use of the vaccine should be based on official recommendations. Adults up to the age of 59 years receive the lower strength (containing 9 micrograms of each virus strain). People aged 60 years and over receive the higher strength (15 micrograms of each virus strain).

The vaccine can only be obtained with a prescription.

How is Intanza used?

Intanza is given as one ‘intradermal’ injection into the upper layer of the skin, using a special micro-injection system. The shoulder is the recommended site of injection.

How does Intanza work?

Intanza is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Intanza contains fragments from three different strains of flu virus. When a person is given the vaccine, the immune system recognises the virus fragments as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these virus strains. The antibodies will then help to protect against the disease caused by these strains of flu virus.

Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season. These virus strains need to be included in Intanza before the vaccine can be used. Intanza currently contains fragments of the virus strains that are expected to cause flu in the 2010/2011 season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU). The virus strains in Intanza will need to be replaced again before the vaccine can be used in subsequent seasons.

How has Intanza been studied?

Five studies involving almost 9,000 people have been carried out to study the effectiveness of Intanza in protecting against flu. Two of the studies looked at people under the age of 60 years, who were vaccinated with the 9‑microgram strength. The other three studies looked at people aged 60 years and over, who were vaccinated with the 15‑microgram strength.

In all studies, Intanza was compared with another flu vaccine given by injection into a muscle. In one study in people aged 60 years and over, Intanza was compared with a vaccine containing an adjuvant (a compound added to enhance the immune response). The studies compared the ability of the vaccines to trigger the production of antibodies (immunogenicity) by comparing antibody levels before injection and three weeks afterwards.

What benefit has Intanza shown during the studies?

In all studies, both Intanza and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains. In adults below 60 years, the 9‑microgram strength provided as good a level of protection as the intramuscular vaccine. In people aged 60 years and over, the 15‑microgram strength provided as good a level of protection as the comparator vaccines.

What is the risk associated with Intanza?

The most common side effects with Intanza (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), malaise (feeling unwell) and local reactions at the site of the 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 substances, any of the other ingredients, egg, chicken protein, neomycin (an antibiotic), formaldehyde (a preservative) or octoxinol 9 (a detergent). People who have a fever or an acute (short-lived) infection should not receive the vaccine until they have recovered.

Why has Intanza been approved?

The CHMP decided that Intanza’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Intanza

The European Commission granted a marketing authorisation valid throughout the EU for Intanza to Sanofi Pasteur MSD SNC on 24 February 2009. The marketing authorisation is valid for five years, after which it can be renewed.

This EPAR was last updated on 08/07/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

09/06/2011  Intanza -EMEA/H/C/000957 -IB/0009

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza in adults up to 59 years of age, especially in those who run an increased risk of associated complications.

The use of Intanza should be based on official recommendations.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents