Fluenz Tetra - Influenza Vaccine

PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED

What is Fluenz Tetra - Influenza Vaccine and what is it used for?

Fluenz Tetra is a vaccine used to protect children and adolescents between the ages of 2 and 18 years of age from influenza. Influenza is caused predominantly by two types of influenza viruses, types A and B. Each of these types circulate under form of different strains or subtypes, which change over time. Fluenz Tetra contains live attenuated (weakened) strains of influenza viruses A and B (type A-H1N1, type AH3N2, type B Victoria lineage and type B Yamagata lineage), based on official recommendations for the annual flu season.

How is Fluenz Tetra used - Influenza Vaccine?

Fluenz Tetra is available in the form of a nasal spray. The recommended dose is one nasal spray (0.1ml) per nostril. Children who have not previously been vaccinated against seasonal flu should be given a second dose four weeks after the first administration. The vaccine can only be obtained with a prescription and should be based on official recommendations.

How does Fluenz Tetra - Influenza Vaccine work?

Fluenz Tetra is a vaccine. Vaccines work by "teaching" the immune system (the body's natural defense system) to defend itself against a disease. Fluenz Tetra contains strains of the flu virus that have previously been attenuated so that they do not cause disease. When a person comes vaccinated, the immune system recognizes the virus as "foreign" and produces defenses that counter it. Later the immune system will be able to react more quickly if it is exposed to the virus again. This will help protect the body against the disease caused. from the virus. Each year, the World Health Organization (WHO) provides recommendations on flu strains to be included in vaccines for the next flu season in the Northern Hemisphere. The two strains A and B present in Fluenz Tetra will be updated each season with attenuated viral strains, in accordance with the recommendations of the WHO and the European Union. Historically, seasonal influenza vaccines contained three influenza strains: a type A-H1N1 influenza virus, a type A-H3N2 influenza virus, and a type B influenza virus. The inclusion of both type B influenza viruses in Fluenz Tetra may confer greater protection against influenza B. The viruses used in Fluenz Tetra are grown in chicken eggs.

What benefit has Fluenz Tetra - Influenza Vaccine shown during the studies?

The company provided three studies comparing Fluenz Tetra with Fluenz, a licensed flu vaccine that contains three of the four strains of flu viruses found in Fluenz Tetra and is now well established to work. Of these studies, the main study involved over 2,000 children and adolescents between the ages of 2 and 17 who were vaccinated with Fluenz Tetra or with "either" of the two Fluenz vaccines containing either. strains of influenza B also present in Fluenz Tetra. The study evaluated the ability of vaccines to stimulate an immune response against influenza by measuring the production of antibodies. The study found that patients vaccinated with Fluenz Tetra had immune responses against each of the four viral strains contained in the vaccine, comparable to the immune responses stimulated by the Fluenz vaccines.

What is the risk associated with Fluenz Tetra - Influenza Vaccine?

The most common side effects with Fluenz Tetra (which may affect more than 1 in 10 people) are decreased appetite, headache, stuffy or runny nose and feeling sick. For the complete list of side effects reported with Fluenz Tetra, see package leaflet. Fluenz Tetra must not be used in children and adolescents who are hypersensitive (allergic) to the active substances or to any of the other ingredients, to gentamicin (a type of antibiotic), or to eggs or egg proteins. It must also not be used in people whose immune systems are weakened due to blood disorders, symptomatic HIV infection and cancer, or in children and adolescents treated with salicylates (painkillers such as aspirin).

Why has Fluenz Tetra - Influenza Vaccine been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Fluenz Tetra's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the immune response stimulated by Fluenz Tetra was similar to the immune response stimulated by Fluenz. Furthermore, the fact that the vaccine is administered as a nasal spray and not by injection and the fact that it contains both influenza B viruses represent two important advantages for the CHMP for children. . The safety profile of Fluenz Tetra is similar to that of Fluenz and was considered acceptable.

What measures are being taken to ensure the safe and effective use of Fluenz Tetra - Influenza Vaccine?

A risk management plan has been developed to ensure that Fluenz Tetra is used as safely as possible. Based on this plan, safety information has been added to the Summary of Product Characteristics and Information Leaflet for Fluenz Tetra, including the appropriate precautions to be followed by healthcare professionals and patients.

More information about Fluenz Tetra - Influenza Vaccine

On 04 December 2013, the European Commission issued a "Marketing Authorization" for Fluenz Tetra, valid throughout the European Union. For more information on Fluenz Tetra therapy, read the package leaflet (included with the EPAR) or consult your doctor or pharmacist. Last update of this summary: 12-2013

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