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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/777825/2012

EMEA/H/C/002094

EPAR summary for the public

Aflunov

prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

This is a summary of the European public assessment report (EPAR) for Aflunov. 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 Aflunov.

What is Aflunov?

Aflunov is a vaccine that contains parts of influenza (flu) viruses that have been inactivated. Aflunov contains a flu strain called A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23).

What is Aflunov used for?

Aflunov is used in adults to protect against flu caused by the H5N1 ('bird flu') strain of the influenza A virus. The vaccine is given according to official recommendations.

The vaccine can only be obtained with a prescription.

How is Aflunov used?

The vaccine is given by injection into the shoulder muscle in two single doses, at least three weeks apart. In the event of an officially declared pandemic caused by the H5N1 strain of the influenza A, people who have already been vaccinated with Aflunov (with one or two doses) may be given only one more dose, instead of the two doses recommended for unvaccinated people.

How does Aflunov work?

Aflunov is a 'prepandemic' vaccine. This is a type of vaccine to be given before or during a flu pandemic.to protect against a new strain of flu that may cause a future influenza pandemic. A flu

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pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus.

Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. This vaccine contains some parts of the H5N1 virus. The virus has first been inactivated so that it does not cause any disease. When a person is given the vaccine, the immune system recognises the virus parts as 'foreign' and makes antibodies against them. The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again. This may help to protect against the disease caused by the virus.

The vaccine contains an 'adjuvant' (a compound containing oil) to enhance the immune response.

How has Aflunov been studied?

At the time of the initial marketing authorisation, two main studies using a strain called A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) provided data on vaccination with Aflunov in healthy adults aged below and above 60 years. In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Aflunov three weeks apart, or placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart. In the second study involving 240 people, subjects were given Aflunov using different vaccination schedules. The studies looked at the ability of the vaccine to trigger the production of antibodies ('immunogenicity') against the flu virus.

A third study, using a vaccine with strain A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), has been carried out in 343 adults aged below and above 60 years.

What benefit has Aflunov shown during the studies?

The two studies at the time of the initial marketing authorisation showed that overall Aflunov produced an acceptable antibody response. In the first study, 21 days after the second injection, around 90% of people aged below 60 years and around 80% of those aged above 60 years had levels of antibodies that would protect them against H5N1. The second study established that Aflunov should be given as two doses at least three weeks apart.

The third study showed that 21 days after the second injection, around 70% of adults below 60 years and around 64% of adults above 60 years produced an acceptable antibody response.

What is the risk associated with Aflunov?

The most common side effects with Aflunov (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness). For the full list of all side effects reported with Aflunov, see the package leaflet.

Aflunov should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low levels) such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), barium sulphate, formaldehyde and cetyltrimethylammonium bromide. However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.

Why has Aflunov been approved?

The CHMP noted that it is likely that a H5N1 strain of the influenza will cause a pandemic in the future. The CHMP decided that Aflunov's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Aflunov

The European Commission granted a marketing authorisation valid throughout the European Union for Aflunov on 29 November 2010.

The full EPAR for Aflunov can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Aflunov, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 12-2012.

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Aflunov

EMA/777825/2012