Flucelvax | European Medicines Agency (EMA)

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Overview

Flucelvax is a vaccine used to protect adults and children from 2 years of age against influenza (flu).

Influenza is mainly caused by two types of influenza virus, known as influenza A and B. Each of these circulate as different strains and subtypes, which change over time.

Flucelvax contains proteins from three different inactivated influenza A and B virus strains (type A-H1N1, type A-H3N2 and one type B strain), chosen based on the official recommendation for the annual flu season.

The vaccine can only be obtained with a prescription and should be used according to official recommendations.

Flucelvax is available as an injection in a pre-filled syringe. The recommended dose is a single injection into a muscle, preferably in the upper arm, or the thigh in infants and young children. Children under 9 years of age who have not been previously vaccinated against flu should receive a second dose at least 4 weeks later.

For more information about using Flucelvax see the package leaflet or contact your doctor or pharmacist.

Flucelvax is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Flucelvax contains proteins from the surface of three different strains of the flu virus.

When a person is given the vaccine, the immune system will treat the virus proteins as ‘foreign’ and make defences against them. If, later on, the person comes into contact with the flu, the immune system will recognise the virus proteins and be prepared to defend the body against the virus. This will help to protect against flu caused by the virus.

Each year, the WHO makes recommendations on which flu strains should be included in vaccines for the upcoming flu season in the northern hemisphere. The composition of Flucelvax will be updated annually according to WHO and EU recommendations.

The company provided data from studies carried out in previous flu seasons to support the marketing authorisation of equivalent or similar flu vaccines, Optaflu and Flucelvax Tetra. Optaflu included virus strains expected to cause flu during the 2007/2008 season, while Flucelvax Tetra includes the three virus strains of Flucelvax, as well as an additional type B strain.

A main study showed that Optaflu was more effective than placebo (a dummy treatment) at preventing flu. The study involved around 11,400 people aged 18 to 49 years who received either Optaflu, a similar flu vaccine that also protects against three virus strains, or placebo. Results showed that Optaflu reduced the number of flu cases, caused by the virus strains in the vaccine, by around 84% compared with placebo.

Two main studies involving around 5,000 people aged 4 years and older compared Flucelvax Tetra with two other vaccines that each protect against three virus strains. The immune response triggered by the vaccines was evaluated by measuring the average antibody levels and the percentage of people whose antibody levels increased significantly, three weeks after vaccination. Results showed that Flucelvax Tetra produced an immune response similar to that of the two other vaccines, leading to comparable levels of protective antibodies in people aged 9 and older.

In another study involving over 4,500 children aged from 2 to less than 18 years of age, Flucelvax Tetra was found to be effective in preventing flu. The study compared Flucelvax Tetra to a non_–influenza vaccine. Flucelvax Tetra reduced the cases of flu: 7.8% of children vaccinated with Flucelvax Tetra got flu compared with 16.2% of those given the non-influenza vaccine.

For the full list of side effects and restrictions with Flucelvax, see the package leaflet.

The most common side effects with Flucelvax in adults and children aged 9 to less than 18 years of age (which may affect more than 1 in 10 people) include pain, reddening and hardening at the site of injection, headache, tiredness and muscle pain.

The most common side effects in children aged 6 to less than 9 years of age with Flucelvax (which may affect more than 1 in 10 children) include pain, reddening, hardening, and bruising at the injection site, tiredness, muscle pain and headache.

The most common side effects in children aged 2 to less than 6 years of age with Flucelvax (which may affect more than 1 in 10 children) include tenderness, reddening, hardening and bruising at the injection site, sleepiness, irritability and change in eating habits.

Flucelvax must not be used in people who are allergic to the active substance, any of the other ingredients, or the following substances which may be present in the vaccine in trace amounts: beta-propiolactone, cetyltrimethylammonium bromide and polysorbate 80.

Each year in Europe, seasonal flu causes up to 50 million cases of illness, and between 15,000 and 70,000 people die from flu-related causes. The effectiveness of Flucelvax in people aged 2 years of age and older is supported by studies for similar or equivalent vaccines used during previous flu seasons that have a similar composition and are made using the same process. These studies have shown that the vaccines trigger a strong immune response to protect against flu and are effective in preventing flu. The safety profile of Flucelvax is expected to be similar to these vaccines, with side effects that are generally mild to moderate and short lived.

The European Medicines Agency therefore decided that Flucelvax’s benefits are greater than its risks and that 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 Flucelvax have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Flucelvax are continuously monitored. Suspected side effects reported with Flucelvax are carefully evaluated and any necessary action taken to protect patients.

Flucelvax received a marketing authorisation valid throughout the EU on 15 November 2024.

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First published: 28/11/2024

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First published: 28/11/2024Last updated: 15/04/2025

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Product information

English (EN)
(370.77 KB – PDF)

First published: 28/11/2024Last updated: 15/04/2025

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Latest procedure affecting product information:
II/0001

10/04/2025

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).

English (EN)
(52.71 KB – PDF)

First published: 28/11/2024

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Product details

Name of medicine: Flucelvax
Active substance: A/Darwin/6/2021(H3N2)-like strain (A/Darwin/11/2021, wild type) / A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022 CVR-167) / B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021) / B/Phuket/3073/2013-like virus (B/Singapore/INFTT-16-0610/2016, wild type)
International non-proprietary name (INN) or common name: influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Therapeutic area (MeSH): Influenza, Human
Anatomical therapeutic chemical (ATC) code: J07BB02

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza in adults and children from 6 months of age.

Flucelvax should be used in accordance with official recommendations.

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Flucelvax | European Medicines Agency (EMA)

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Flucelvax | European Medicines Agency (EMA)

Overview

How is Flucelvax used?

How does Flucelvax work?

What benefits of Flucelvax have been shown in studies?

What are the risks associated with Flucelvax?

Why is Flucelvax authorised in the EU?

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

Other information about Flucelvax

Product information

Product details

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