Active Substance: A/California/7/2009 (H1N1)pdm09-derived strain used (NYMC X-179A)
A/Victoria/361/2011 (H3N2)-like strain used (NYMC X-223A) derived from A/Texas/50/2012
Common Name: influenza vaccine (split virion, inactivated)
ATC Code: J07BB02
Marketing Authorisation Holder: Sanofi Pasteur S.A.
Active Substance: A/California/7/2009 (H1N1)pdm09-derived strain used (NYMC X-179A) A/Victoria/361/2011 (H3N2)-like strain used (NYMC X-223A) derived from A/Texas/50/2012 B/Massachusetts/02/2012
Authorisation Date: 2009-02-24
Therapeutic Area: Influenza, Human Immunization
Pharmacotherapeutic Group: Vaccines
Prophylaxis of influenza in adults up to 59 years of age, especially in those who run an increased risk of associated complications.
The use of IDflu should be based on official recommendations.
Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.
The use of IDflu should be based on official recommendations.
What is IDflu?
IDflu is a vaccine, which is available as a suspension for injection in a pre‑filled syringe. The vaccine contains fragments of influenza (flu) viruses that have been inactivated (treated to prevent them causing infection). IDflu contains 15 micrograms of each of three different strains (varieties) of influenza virus (an H1N1 subtype, A/California/7/2009, NYMC X-179A; an H3N2 subtype, A/South Australia/55/2014, IVR-175; and a type B, B/Phuket/3073/2013).
What is IDflu used for?
IDflu is used to vaccinate adults aged 60 years and over against flu, especially those who are at an increased risk of developing complications from the disease. The use of the vaccine should be based on official recommendations.
The vaccine can only be obtained with a prescription.
How is IDflu used?
IDflu is given as one ‘intradermal’ injection into the upper layer of the skin, using a special micro‑injection system. The shoulder is the recommended site of injection.
How does IDflu work?
IDflu is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. IDflu contains fragments from 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 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. Fragments of the virus strains that are expected to cause flu in the upcoming season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU), need to be included in IDflu before the vaccine can be used.
How has IDflu been studied?
The ability of IDflu to trigger the production of antibodies (immunogenicity) was first assessed in five main studies involving almost 9,000 people. Three studies looked at people aged 60 years and over, who were vaccinated with the 15 microgram strength. The other two studies looked at use of a lower strength in people under the age of 60.
In all studies, IDflu was compared with another flu vaccine given by injection into a muscle. In one study in people aged 60 years and over, IDflu was compared with a flu vaccine containing an adjuvant (a compound added to enhance the immune response). The studies compared the ability of the vaccines to trigger the production of antibodies (immunogenicity) by comparing antibody levels before injection and three weeks afterwards.
The immunogenicity and safety of subsequent formulations of the vaccine have also been examined in studies.
What benefit has IDflu shown during the studies?
In the five original studies, both IDflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains. In people aged 60 years and over, the 15‑microgram strength provided as good a level of protection as the comparator vaccines.
Later seasonal formulations of IDflu have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main studies.
What is the risk associated with IDflu?
The most common side effects with IDflu (seen in more than 1 patient in 10) are headache, muscle pain, malaise (feeling unwell) and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching). For the full list of all side effects reported with IDflu, see the package leaflet.
IDflu must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients, or to any component that may be present in very small amounts such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol 9. People who have fever or an acute (short-lived) infection should not receive the vaccine until they have recovered.
Why has IDflu been approved?
The CHMP decided that IDflu’s benefits are greater than its risks and recommended that it be given marketing authorisation.
What measures are being taken to ensure the safe and effective use of IDflu?
A risk management plan has been developed to ensure that IDflu 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 IDflu, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about IDflu
The European Commission granted a marketing authorisation valid throughout the EU for IDflu on 24 February 2009.
For more information about treatment with IDflu, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.