Optaflu

Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Optaflu?

Optaflu is a vaccine, which is available as a suspension for injection in a pre-filled syringe. The vaccine contains the inactivated ‘surface antigen’ from three different strains (types) of influenza (flu) virus as active substances (A/Solomon Islands/3/2006, A/Wisconsin/67/2005 and B/Malaysia/2506/2004).

What is Optaflu used for?

Optaflu 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.

The vaccine can only be obtained with a prescription.

How is Optaflu used?

Optaflu is given as one injection of 0.5 ml into the muscle at the top of the arm.

How does Optaflu work?

Optaflu is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Optaflu contains fragments from the surface of 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 the 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, and these virus strains need to be included in Optaflu before the vaccine can be used. Optaflu currently contains fragments of the virus strains that are expected to cause flu in the 2007/2008 season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU). The virus strains in Optaflu will be need to be replaced again before the vaccine can be used in subsequent seasons.

The viruses used in Optaflu are grown in mammal cells, unlike those in other flu vaccines, which are grown in hen’s eggs.

How has Optaflu been studied?

The effects of Optaflu were first tested in experimental models before being studied in humans.

The effectiveness of Optaflu was first assessed using a formulation of the vaccine that included the virus strains expected to cause flu in the 2004/2005 season. The vaccine’s effectiveness was assessed in one main study involving 2,654 adults, around half of whom were elderly (over 60 years of age). The effects of Optaflu were compared to those of a similar flu vaccine that was made in eggs. The study compared the ability of the two vaccines to trigger the production of antibodies (immunogenicity), by comparing antibody levels before injection and three weeks afterwards.

The immunogenicity of the current formulation of the vaccine has been confirmed in 135 adults, around half of whom were elderly.

What benefit has Optaflu shown during the studies?

In the original main study, both Optaflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains, as defined in criteria laid down by the Committee for Medicinal Products for Human Use (CHMP) for flu vaccines produced in cell culture. The two vaccines were similar in triggering the production of antibodies, both in adults 60 years of age and below, and in the elderly.

The current formulation of Optaflu for the 2007/2008 season brought about similar antibody responses against the three flu strains included in the vaccine to those seen in the main study.

What is the risk associated with Optaflu?

The most common side effects with Optaflu (seen in more than 1 patient in 10) are headache, erythema (reddening of the skin), pain, malaise (feeling unwell) and fatigue (tiredness). These side effects usually disappear within one to two days without treatment. For the full list of all side effects reported with Optaflu, see the Package Leaflet.

Optaflu should not be used in people who may be hypersensitive to the active substances or any of the other ingredients. People who have a fever or an acute (short-lived) infection should not receive the vaccine until they have recovered.

Why has Optaflu been approved?

The CHMP decided that Optaflu’s benefits are greater than its risks for the prophylaxis of influenza for adults, especially those who run an increased risk of associated complications. The Committee recommended that Optaflu be given marketing authorisation.

Other information about Optaflu

The European Commission granted a marketing authorisation valid throughout the EU for Optaflu to Novartis Vaccines and Diagnostics GmbH & Co. KG on 1 June 2007.

This EPAR was last updated on 06/05/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

04/04/2011  Optaflu -EMEA/H/C/000758 -IA/0027/G

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 for adults, especially in those who run an increased risk of associated complications.

The use of Optaflu should be based on official recommendations.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents