Fluad Tetra
Authorised
This medicine is authorised for use in the European Union
influenza vaccine (surface antigen, inactivated, adjuvanted)
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Fluad Tetra is a vaccine used to protect people aged from 50 years against influenza (flu).
Flu is caused mainly by two types of influenza virus, known as influenza A and B. Each of these circulate as different strains, which change over time.
Fluad Tetra contains proteins from four different inactivated influenza A and B virus strains (type A H1N1, type A H3N2 and two type B strains). They are chosen according to the official recommendation for the annual flu season.
The vaccine also contains an adjuvant, which helps to improve the vaccine's effectiveness. The viruses used in Fluad Tetra are grown in fertilised hens’ eggs.
Fluad Tetra is given as a single injection into a muscle, preferably in the upper arm.
The vaccine can only be obtained with a prescription, and it should be used according to official recommendations issued at national level by public health bodies.
For more information about using Fluad Tetra, see the package leaflet or contact your doctor or pharmacist.
Fluad Tetra is a vaccine. Vaccines work by preparing the immune system (the body’s natural defences) to defend the body against a specific disease. Fluad Tetra contains small amounts of proteins of influenza viruses. When a person is given the vaccine, the immune system recognises the proteins in the vaccine as ‘foreign’ and makes antibodies against them. The immune system will then be able to respond more quickly when exposed to the virus. This will help to protect against flu.
Each year, the World Health Organization (WHO) recommends which flu strains should be included in flu vaccines for the upcoming flu season in the northern hemisphere. The composition of Fluad Tetra will be updated annually according to WHO and EU recommendations.
Studies in people aged 50 years or more investigated the effectiveness of Fluad Tetra at triggering the production of protective antibodies against flu.
A study involving over 7,000 people aged 65 years or above found that antibody levels were generally higher when an adjuvant was included in the vaccine. The study compared an influenza vaccine that did not contain an adjuvant with one that contained the same adjuvant as Fluad Tetra. Both vaccines contained three of the four virus strains covered by Fluad Tetra.
A second study involving 1,776 people aged 65 years or above found that after 22 days the level of antibodies resulting from Fluad Tetra vaccination was similar to that resulting from two other vaccines, each containing both influenza A virus strains and either one of the influenza B virus strains contained in Fluad Tetra. All vaccines contained the same adjuvant.
Another study involved 2,044 people aged 50 to 64 years who received either Fluad Tetra or another influenza vaccine also containing four virus strains, but no adjuvant. Three weeks after vaccination, the level of antibodies produced against each of the four virus strains in response to Fluad Tetra vaccination was similar to that seen with the comparator vaccine. Further results showed that, compared with the comparator vaccine, Fluad Tetra vaccination led to higher levels of antibodies, although not against all 4 virus strains.
However, additional data showing that, in people aged 50 to 64 years, vaccination with an influenza vaccine containing three virus strains and an adjuvant produced higher antibody levels than vaccination with a comparable vaccine that did not contain an adjuvant. Further evidence from observational studies and public health monitoring also supports the effectiveness of influenza vaccines containing an adjuvant in the 50-64 years age group.
The company also presented information on the use of Fluad Tetra in children aged between 6 months and 6 years, but withdrew its application for this use. Results from these studies did not clearly show that Fluad Tetra was sufficiently effective in protecting children against influenza.
For the full list of side effects and restrictions of Fluad Tetra, see the package leaflet.
The most common side effects with Fluad Tetra (which may affect more than 1 in 10 people), which generally last up to 3 days, include pain at the injection site, tiredness and headache. In people aged 50 to less than 65 years, other common side effects include arthralgia (joint pain) and myalgia (muscle pain).
Fluad Tetra must not be used in people allergic to the active substances or any of the other ingredients or to the following substances which may be present in the vaccine in trace amounts: ovalbumin (egg protein), the antibiotics kanamycin and neomycin, formaldehyde, cetyltrimethylammonium bromide or hydrocortisone.
The vaccine must also not be used by people who have had anaphylaxis (a sudden, severe allergic reaction) to previous influenza vaccination.
In people aged 65 years and over, Fluad Tetra stimulates a higher level of antibody production than influenza vaccines that do not contain an adjuvant. The vaccine is also expected to be effective in people aged 50 to less than 65 years. Because Fluad Tetra includes two influenza B virus strains, it can give broader protection than previous vaccines that contained only one strain. Side effects of Fluad Tetra are mostly mild to moderate and last only a short time.
The European Medicines Agency therefore decided that Fluad Tetra’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fluad Tetra have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Fluad Tetra are continuously monitored. Side effects reported with Fluad Tetra are carefully evaluated and any necessary action taken to protect patients.
Fluad Tetra received a marketing authorisation valid throughout the EU on 20 May 2020.
Product information
Latest procedure affecting product information:
R/0055
19/12/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Fluad Tetra
- Active substance
- A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) / A/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022 IVR-237) / B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) influenza virus
- International non-proprietary name (INN) or common name
- influenza vaccine (surface antigen, inactivated, adjuvanted)
- Therapeutic area (MeSH)
- Influenza, Human
- Anatomical therapeutic chemical (ATC) code
- J07BB02
Pharmacotherapeutic group
VaccinesTherapeutic indication
Prophylaxis of influenza in adults 50 years of age and older.
Fluad Tetra should be used in accordance with official recommendations.
News on Fluad Tetra
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