Flucelvax Tetra

Flucelvax Tetra is available as a suspension for injection in a pre-filled syringe. The recommended dose is one single injection into a muscle (0.5 ml), preferably in the upper arm.

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

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

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

When a person is given the vaccine, the immune system recognises the virus proteins as ‘foreign’ and makes defences against them. The immune system will then be able to respond more quickly when it is exposed to the virus again. This will help to protect against the disease caused by the virus.

Each year, the World Health Organization (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 Tetra will be updated annually according to WHO and EU recommendations. Historically, seasonal flu vaccines have contained three strains of flu: one influenza A-H1N1 virus, one influenza A-H3N2 virus, and one influenza B virus. Flucelvax Tetra includes an additional B virus strain.

The viruses used to produce Flucelvax Tetra are grown in mammalian cells.

Flucelvax Tetra was compared with two comparator vaccines in 2 main studies. One of the vaccines was Optaflu, a previously authorised vaccine which contains three of the four strains of influenza in Flucelvax Tetra and whose effectiveness in preventing flu is well established. The other vaccine is based on Optaflu but contains the other B strain of Flucelvax Tetra. Together the comparator vaccines contain the four strains of influenza in Flucelvax Tetra.

The studies assessed the ability of the vaccines to stimulate an immune response against influenza, by measuring the production of protective antibodies. They involved over 5,000 people from 4 years of age. Results showed that Flucelvax Tetra lead to similar levels of protective antibodies as the comparator vaccines in people from 9 years of age. 

The most common side effects with Flucelvax Tetra (which may affect more than 1 in 10 people) are pain at the injection site, reddening of the skin and hardening at the injection site, headache, tiredness and muscle pain.

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

Flucelvax Tetra is as effective as the comparator vaccines at stimulating immune responses against the 4 strains included in the vaccine in people from 9 years of age. The inclusion of two influenza B strains in Flucelvax Tetra can provide a broader protection against influenza B. In terms of safety, side effects with Flucelvax Tetra are similar to those observed with vaccines containing three influenza strains and are mostly mild to moderate in severity.

The European Medicines Agency therefore decided that Flucelvax 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 Flucelvax Tetra have been included in the summary of product characteristics and the package leaflet.

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

Flucelvax Tetra received a marketing authorisation valid throughout the EU on 12 December 2018.