Fluenz Free Trial
Giorgina Makara
AstraZeneca today announced that the European Commission (EC) has granted Marketing Authorisation to FluenzTM Tetra. Fluenz Tetra is a nasally administered four-strain live attenuated influenza vaccine for the prevention of influenza in children and adolescents from 24 months up to 18 years of age. The EC approval makes Fluenz Tetra the first and only intra-nasal four-strain influenza vaccine available in Europe.
Historically, seasonal flu vaccines have contained three strains of influenza: two influenza A viruses (H1N1 and H3N2) and one influenza B virus. Fluenz Tetra contains an additional influenza B strain. Over the past decade, influenza B strains accounted for approximately 25 percent of the influenza strains circulating in Europe.
The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use on 19 September 2013, and is applicable to all 28 member states and the three European Economic Area countries of the European Union.
Influenza is the most common vaccine-preventable disease in the developed world. In Europe and throughout the world, influenza creates a significant medical and economic burden. According to World Health Organization (WHO) estimates, seasonal influenza results in three to five million cases of severe illness and up to half a million deaths globally each year. Rates of infection are highest among children, and school-aged children are recognised as the main transmitters of the flu virus. Vaccinating children can lower the overall burden of influenza. This is achieved through direct protection of the child and through indirect effects that are a result of decreased transmission of the virus from children to others in the community, often referred to as herd immunity.
Fluenz Tetra is formulated to contain four live attenuated influenza virus strains that are weakened so as to not cause illness.The vaccine is administered by spraying into each nostril where it induces protective immunity. The most common adverse reactions for Fluenz Tetra include runny nose or nasal congestion.
In the US, Fluenz Tetra is marketed by MedImmune Specialty Care Division of AstraZeneca, under the trade name FluMist Quadrivalent (Influenza Vaccine Live, Intranasal). FluMist Quadrivalent was approved by the US Food and Drug Administration (FDA) on 29 February 2012.
Vaccine strains are recommended annually by the World Health Organization (WHO) based on anticipated circulating influenza strains for the upcoming season. Historically, seasonal flu vaccines have been trivalent formulations, meaning they contain three strains of influenza: one influenza A (H1N1) virus, one influenza A (H3N2) virus, and one influenza B virus. However, new tetravalent (also referred to as quadrivalent) flu vaccines contain two strains of influenza A and two strains of influenza B to provide broad protection against influenza B.
Since 2001, influenza B strains from two different lineages (B/Yamagata and B/Victoria) have co-circulated each influenza season in Europe. Trivalent vaccine formulations rely on predictions of which influenza B strains will be dominant in the upcoming season. However, B strain circulation has been difficult to predict correctly, and in the last decade, the vaccine B strain only matched the dominant circulating B strain about every other year.
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AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on Fluenz Tetra, a nasally administered four-strain live attenuated influenza vaccine, for the prevention of seasonal influenza in eligible children and adolescents 24 months to 17 years of age.
Historically, seasonal flu vaccines have contained three strains of influenza: one influenza A (H1N1) virus, one influenza A (H3N2) virus, and one influenza B virus. However, Fluenz Tetra contains two strains of influenza A and two strains of influenza B to provide broad protection against influenza B. Influenza B strains on average account for approximately 25 percent of the influenza strains that circulate in Europe.
The positive opinion was reached after a review of data from a pivotal paediatric study. These data indicated that the safety and immunogenicity profile of Fluenz Tetra was comparable to currently approved three-strain (trivalent) vaccine, Fluenz.
Since 2001, influenza B strains from two different lineages (B/Yamagata and B/Victoria) have co-circulated each influenza season in Europe. Trivalent vaccine formulations rely on predictions of which influenza B strains will be dominant in the upcoming season. However, B strain circulation has been difficult to predict correctly, and in recent years, the vaccine B strain did not match the dominant circulating B strain.
This is a summary of the European public assessment report (EPAR) for Fluenz Tetra. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Fluenz Tetra.
Fluenz Tetra is a vaccine used to protect children from 2 to less than 18 years of age against influenza (flu). Influenza is mainly caused by two kinds of influenza virus, known as influenza A and B. Each of these circulates as different strains or subtypes, which change over time. Fluenz Tetra will contain live attenuated (weakened) influenza A and B virus strains (type A-H1N1, type A-H3N2 and two type B strains) based on the official recommendation for the annual flu season.
Fluenz Tetra is available as a nasal spray. The recommended dose is one nasal spray (0.1 ml) per nostril. Children who have not been previously vaccinated against seasonal influenza should receive a second dose 4 weeks after the first.
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 two A and two B strains in Fluenz Tetra will be updated with weakened virus strains for each season, according to WHO and European Union recommendations. Historically, seasonal flu vaccines have contained three strains of influenza: one influenza A-H1N1 virus, one influenza A-H3N2 virus, and one influenza B virus. The inclusion of both influenza B viruses in Fluenz Tetra can provide a broader protection against influenza B.
The company provided three studies that compared Fluenz Tetra with Fluenz, an authorised influenza vaccine that contains three of the four strains of influenza in Fluenz Tetra and whose effectiveness is already established.
Of these studies the main study involved over 2,000 children aged 2 to 17 years who were vaccinated with either Fluenz Tetra or one of two Fluenz vaccines containing either one of the two influenza B strains which are also contained in Fluenz Tetra. The study assessed the ability of the vaccines to stimulate an immune response against influenza, by measuring the production of protective antibodies. The study showed that patients vaccinated with Fluenz Tetra had immune responses against each of the four vaccine virus strains that were comparable to the immune responses stimulated by the Fluenz vaccines.
The most common side effects with Fluenz Tetra (seen in more than 1 patient in 10) are reduced appetite, headache, blocked or runny nose and malaise (feeling unwell). For the full list of all side effects reported with Fluenz Tetra, see the package leaflet.
Fluenz Tetra must not be used in children who are hypersensitive (allergic) to the active substances or any of the other ingredients, to gentamicin (a type of antibiotic), or to eggs or egg proteins. It must also not be given to children with a weakened immune system due to conditions such as blood disorders, symptomatic HIV infection, cancer or certain medical treatments, nor to children who are receiving treatment with salicylates (painkillers such as aspirin).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fluenz Tetra have been included in the summary of product characteristics and the package leaflet.
Live attenuated influenza vaccine (LAIV) is an intranasally administered trivalent, seasonal influenza vaccine that contains three live influenza viruses (two type A [H1N1 and H3N2 subtypes] and one type B).
LAIV did not differ significantly from placebo in preventing febrile illnesses in adults (primary endpoint) enrolled in a phase III trial. However, LAIV significantly reduced the incidence of febrile upper respiratory tract illnesses (URTI), severe febrile illnesses, febrile URTI-related work absenteeism and healthcare provider use. In another well designed trial in adults, LAIV significantly reduced the incidence of symptomatic, laboratory-confirmed influenza compared with placebo (but not intramuscular TIV).
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