PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Fluenz Tetra - Vaccine Influenza and what is it used for?
Fluenz Tetra is a vaccine used to protect children and adolescents between the ages of 2 and 18 from influenza. The flu is mainly caused by two types of influenza viruses, types A and B. Each of these types circulates in the form of different strains or subtypes, which change over time. Fluenz Tetra contains the live attenuated (weakened) strains of influenza viruses A and B (type A-H1N1, type AH3N2, type B lineage Victoria and type B lineage Yamagata), based on official recommendations for the annual flu season.
How is Fluenz Tetra - Vaccine Influenza used?
Fluenz Tetra is available as a nasal spray. The recommended dose is a nasal spray (0.1 ml) 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 must be based on official recommendations.
How does Fluenz Tetra - Vaccine Influenza work?
Fluenz Tetra is a vaccine. Vaccines act by "teaching" the immune system (the body's natural defense system) to defend itself against a disease. Fluenz Tetra contains strains of the influenza virus that has previously been attenuated so as not to cause the disease. When a person is vaccinated, the immune system recognizes the virus as "foreign" and produces defenses that counteract it. The immune system will then be able to react more quickly if it is exposed to the virus again. This will help protect the body against the disease caused by the virus. Each year, the World Health Organization (WHO) provides recommendations on which flu strains should 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: an influenza virus type A-H1N1, an influenza virus type A-H3N2 and a type B influenza virus. The inclusion of both type B influenza viruses in Fluenz Tetra can provide better protection against the flu. B. The viruses used in Fluenz Tetra are grown in chicken eggs.
What benefit has Fluenz Tetra - Vaccine Influenza shown during the studies?
The company provided three studies comparing Fluenz Tetra with Fluenz, an authorized flu vaccine that contains three of the four influenza virus strains present in Fluenz Tetra and whose effectiveness is now well established. Of these studies, the main study was conducted on over 2, 000 children and adolescents aged between 2 and 17 years, who were vaccinated with Fluenz Tetra or with one or other of the two Fluenz vaccines containing one of the two strains of influenza B also present in Fluenz Tetra. The study assessed 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 - Vaccine Influenza?
The most common side effects with Fluenz Tetra (which may affect more than 1 in 10 people) are decreased appetite, headache, blocked or runny nose and malaise. For the full list of all side effects reported with Fluenz Tetra, see the package leaflet. Fluenz Tetra should not be used in children and adolescents who are hypersensitive (allergic) to the active ingredients or any of the other ingredients, to gentamicin (a type of antibiotic), or to eggs or egg proteins. Furthermore, it must not be given to subjects whose immune system is weakened due to blood disorders, symptomatic HIV infection and cancer, nor to children and adolescents treated with salicylates (painkillers such as aspirin)
Why has Fluenz Tetra - Vaccine Influenza 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 represents 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 - Vaccine Influenza?
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 included in the summary of product characteristics and the information sheet for Fluenz Tetra, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Fluenz Tetra - Vaccine Influenza
On 4 December 2013, the European Commission issued a marketing authorization for Fluenz Tetra, valid throughout the European Union. For more information about treatment with Fluenz Tetra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 12-2013
