Foclivia

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

  • Email
  • Help

About

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 for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

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.

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

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 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 Committee for Medicinal Products for Human Use (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.

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’). 

For more information about treatment with Foclivia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Foclivia : EPAR - Summary for the public BG = bălgarski 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public ES = español 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public CS = čeština 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public DA = dansk 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public DE = Deutsch 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public ET = eesti keel 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public EL = elliniká 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public EN = English 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public FR = français 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public IT = italiano 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public LV = latviešu valoda 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public LT = lietuvių kalba 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public HU = magyar 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public MT = Malti 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public NL = Nederlands 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public PL = polski 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public PT = português 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public RO = română 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public SK = slovenčina 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public SL = slovenščina 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public FI = suomi 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public SV = svenska 2009-12-17 2014-08-06
Foclivia : EPAR - Summary for the public HR = Hrvatski 2009-12-17 2014-08-06

This EPAR was last updated on 08/03/2016 .

Authorisation details

Product details

Product details for Foclivia
NameFoclivia
Agency product numberEMEA/H/C/001208
Active substance

influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1)

International non-proprietary name (INN) or common name

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

Therapeutic area Influenza, HumanImmunizationDisease Outbreaks
Anatomical therapeutic chemical (ATC) code J07BB02
Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Foclivia
Marketing-authorisation holder

Novartis Vaccines Influenza Srl


 

Revision4
Date of issue of marketing authorisation valid throughout the European Union19/10/2009

Contact address:

Novartis Vaccines Influenza Srl
Via Fiorentina 1
53100 Siena
Italy

Product information

Product information

05/02/2016  Foclivia -EMEA/H/C/001208 -IAIN/0021/G

Name Language First published Last updated
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08
Foclivia : EPAR - Product Information HR = Hrvatski 2009-12-17 2016-03-08

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.


Name Language First published Last updated
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  
Foclivia : EPAR - All Authorised presentations HR = Hrvatski 2009-12-17  

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza in an officially declared pandemic situation.

Pandemic influenza vaccine should be used in accordance with official guidance.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Foclivia : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2012-06-11 2016-03-08

Initial marketing-authorisation documents

Name Language First published Last updated
Foclivia : EPAR - Public assessment report HR = Hrvatski 2009-12-17  
Committee for medicinal products for human use summary of positive opinion for Foclivia HR = Hrvatski 2009-07-23  

Authorised

This medicine is approved for use in the European Union