Aflunov

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

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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 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 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.

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

Name Language First published Last updated
Aflunov : EPAR - Summary for the public BG = bălgarski 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public ES = español 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public CS = čeština 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public DA = dansk 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public DE = Deutsch 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public ET = eesti keel 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public EL = elliniká 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public EN = English 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public FR = français 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public IT = italiano 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public LV = latviešu valoda 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public LT = lietuvių kalba 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public HU = magyar 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public MT = Malti 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public NL = Nederlands 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public PL = polski 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public PT = português 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public RO = română 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public SK = slovenčina 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public SL = slovenščina 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public FI = suomi 24/01/2011 26/06/2013
Aflunov : EPAR - Summary for the public SV = svenska 24/01/2011 26/06/2013

This EPAR was last updated on 14/06/2016 .

Authorisation details

Product details

Product details for Aflunov
NameAflunov
Agency product numberEMEA/H/C/002094
Active substance

influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)

International non-proprietary name (INN) or common name

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

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

Publication details

Publication details for Aflunov
Marketing-authorisation holder

Seqirus S.r.l.


 

Revision7
Date of issue of marketing authorisation valid throughout the European Union29/11/2010

Contact address:

Seqirus S.r.l.
Via Fiorentina 1
I-53100
Siena
Italy

Product information

Product information

13/05/2016  Aflunov -EMEA/H/C/002094 -IAIN/0028/G

Name Language First published Last updated
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016
Aflunov : EPAR - Product Information SV = svenska 24/01/2011 14/06/2016

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
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012
Aflunov : EPAR - All Authorised presentations SV = svenska 24/01/2011 12/06/2012

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Active immunisation against H5N1 subtype of influenza-A virus.

This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/turkey/Turkey/1/05 (H5N1)-like strain.

Aflunov should be used in accordance with official recommendations. 

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Aflunov : EPAR - Public assessment report SV = svenska 24/01/2011  
CHMP summary of positive opinion for Aflunov SV = svenska 24/09/2010  

Authorised

This medicine is approved for use in the European Union