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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/440746/2014

EMEA/H/C/001208

EPAR summary for the public

Foclivia

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

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

What is Foclivia?

Foclivia is a vaccine. It is available as a suspension for injection that contains some parts of inactivated (killed) influenza (flu) virus. It contains a flu strain called A/Viet Nam/1194/2004 (H5N1).

What is Foclivia used for?

Foclivia is a vaccine that can only be used once a flu 'pandemic' has been officially declared by the World Health Organization (WHO) or the European Union (EU). A flu pandemic occurs when a new type (strain) of flu virus emerges 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. Foclivia would be given according to official recommendations.

The vaccine can only be obtained with a prescription.

How is Foclivia used?

Foclivia is given in two doses, at least three weeks apart. It is given by injection into the upper arm muscle or the thigh.

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How does Foclivia work?

Foclivia is a 'mock-up' vaccine. This is a special type of vaccine that can be developed to help with the management of a future pandemic.

Before a pandemic starts, nobody knows which strain of flu virus will be involved, so companies cannot prepare the correct vaccine in advance. Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune. They can test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing a pandemic is included.

Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. Foclivia contains small amounts of parts of a virus called H5N1.The virus has been first inactivated (killed) so that it does not cause any disease. During a pandemic, the virus strain in Foclivia will have to be replaced by the strain causing the pandemic before the vaccine can be used.

When a person is given the vaccine, the immune system recognises the virus as 'foreign' and makes antibodies against it. The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again. This helps to protect against the disease caused by the virus. The vaccine also contains an 'adjuvant' (a compound containing oil) to stimulate a better response.

How has Foclivia been studied?

The main study of Foclivia included 486 healthy subjects (a third of whom were over the age of 60) and compared the ability of two doses of Foclivia to trigger the production of antibodies (immunogenicity). The participants received two injections of Foclivia, containing either 7.5 or 15 micrograms of haemagglutinin (a protein found in flu viruses), 21 days apart. The main measures of effectiveness were the levels of antibodies against the flu virus in the patients' blood before vaccination, on the day of the second injection (day 22), and 21 days later (day 43).

What benefit has Foclivia shown during the studies?

According to criteria laid down by the CHMP, a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.

The study showed that Foclivia produced an antibody response that satisfies these criteria. Twenty-one days after the second injection, 86% of the people receiving the vaccine with 7.5 micrograms haemagglutinin had levels of antibodies that would protect them against H5N1. The figure was 85% in the patients who received the 15-microgram dose.

What is the risk associated with Foclivia?

The most common side effects with Foclivia (seen in between 1 and 10 people in 100) are headache, sweating, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (redness, swelling, hardening, bruising, pain), fever, malaise (feeling unwell), fatigue (tiredness) and shivering. The majority of these side effects disappear within 1 to 2 days. For the full list of all side effects reported with Foclivia, see the package leaflet.

Foclivia should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace levels in the vaccine, such as eggs, chicken protein, kanamycin or neomycin sulphate (two antibiotics), formaldehyde, barium sulphate and cetyltrimethylammonium bromide (CTAB). If a pandemic has

Foclivia

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started, however, it may be appropriate to give the vaccine to these patients, as long as facilities for resuscitation are available.

Why has Foclivia been approved?

The CHMP decided that Foclivia's benefits are greater than its risk and recommended that it be given marketing authorisation.

Foclivia has been authorised under 'exceptional circumstances'. This means that, because the vaccine is a mock-up and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Foclivia?

When the company that makes Foclivia includes the flu strain responsible for a pandemic in the vaccine, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.

What measures are being taken to ensure the safe and effective use of Foclivia?

A risk management plan has been developed to ensure that Foclivia is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Foclivia, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Foclivia

The European Commission granted a marketing authorisation valid throughout the European Union for Foclivia on 19 October 2009. The authorisation was based on the authorisation granted to Focetria in 2007 ('informed consent').

The full EPAR for Foclivia 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 Foclivia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2014.

Foclivia

EMA/440746/2014