What is Fluenz - flu shot?
Fluenz is a vaccine available as a nasal spray that protects against influenza A (subtypes H1N1 and H3N2) and influenza B. It contains live attenuated (weakened) strains of the influenza virus based on the official recommendation for the annual influenza season.
What is Fluenz used for - flu shot?
Fluenz is used to prevent influenza in children and adolescents aged 24 months to 18 years.
The vaccine can only be obtained with a prescription. Its use must be based on official recommendations.
How is Fluenz used - flu shot?
Fluenz is supplied as a nasal spray in a disposable nasal applicator (administered in doses of 0.1 ml in each nostril). It is to be used only as a nasal spray and must not be injected. Children who have not previously been vaccinated against seasonal flu should be given a second dose at least 4 weeks after the first.
How does Fluenz work - flu shot?
Fluenz is a vaccine. Vaccines work by "teaching" the immune system (the body's natural defense system) how to defend itself against a disease. Fluenz contains strains of the flu virus that have been weakened so that they cannot cause disease.
When the vaccine is given, the immune system recognizes the virus as 'foreign' and develops defenses to counter it. The immune system can then respond more quickly when it is exposed to the virus again, helping to protect the body against disease caused by the virus.
Each year the World Health Organization (WHO) makes recommendations on influenza virus strains to include in vaccines for the next flu season. These virus strains must be included in Fluenz before it can be used. Fluenz will be updated with weakened strains. type A-H1N1, A-H3N2 and B of the virus for each season, according to the recommendations issued by the WHO and the European Union for the Northern Hemisphere.
The viruses used in Fluenz grew on chicken eggs.
How has Fluenz been studied - flu vaccine?
The effects of Fluenz were first tested in experimental models before being studied in humans.
Nine main studies involving around 24,000 children and adolescents and four studies involving around 11,000 adults compared Fluenz with a placebo (a vaccine with no specific therapeutic activity) or another injectable flu vaccine containing inactivated (killed) viral source material of the same three flu strains. The flu strains were selected taking into account the flu season. The main measure of effectiveness was the number of laboratory-confirmed cases of influenza caused by the three strains during the influenza season under consideration, although one of the adult studies measured the number of cases of febrile illness (rather than confirmed cases of influenza).
What benefit has Fluenz - influenza vaccine shown during the studies?
In studies in children and adolescents, Fluenz reduced the number of influenza cases caused by the three influenza strains by between 62% and 100% compared to placebo and between 35% and 53% compared to the reference inactivated vaccine.
Studies in adults have shown that Fluenz may have some benefits over placebo, however the results have been mixed. Studies have also shown that Fluenz is not as effective as the reference inactivated vaccine in adults.
What are the risks associated with Fluenz - flu shot?
The most common side effects of Fluenz (seen in more than 1 in 10 patients) are decreased appetite, headache, runny or stuffy nose and feeling sick. For the full list of side effects reported with Fluenz, see the leaflet. illustrative.
Fluenz must not be used in people who may be hypersensitive (allergic) to the active substances, to any of the other ingredients, to gentamicin (a type of antibiotic), to eggs or to egg proteins. It should also not be given to people with weakened immune systems as a result of conditions such as blood disorders, symptomatic HIV infection and cancer or certain medical treatments. It must not be given to children who are taking salicylate therapy (used in medicines such as aspirin to relieve pain).
Why has Fluenz - flu vaccine been approved?
The CHMP pointed out that the studies have convincingly shown that Fluenz is more effective than placebo and the inactivated reference vaccine in children and adolescents, but not in adults. The CHMP therefore decided that the benefits of Fluenz outweigh the risks in children and adolescents aged 24 months to 18 years and recommended granting marketing authorization for this patient group.
Learn more about Fluenz - flu shot
On January 27, 2011, the European Commission granted MedImmune, LLC a "Marketing Authorization" for Fluenz, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
Last update of this summary: 01-2011.
The information on Fluenz - flu shot published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
