title: Flucelvax (Optaflu) for   seasonal influenza.
abstract: Conventional egg-based manufacturing technology for seasonal influenza vaccines has several drawbacks, including its inflexibility, reliance on egg supplies, risk of contamination, absence of growth of some isolates and egg-adaptive viral mutations that threaten vaccine matching. To overcome these limitations, cell culture-derived vaccines have been designed, including the trivalent inactivated vaccine Flucelvax®/Optaflu® (brand names in the US/EU, respectively). Flucelvax®/Optaflu® has gained wide regulatory approval and is currently implemented in several countries. Non-clinical studies have assuaged hypothetical concerns regarding oncogenicity and use in persons allergic to dogs. Ample clinical data suggest the non-inferiority of Flucelvax®/Optaflu® to egg-based vaccines in terms of immunogenicity, safety and tolerability, and it has fulfilled American and European mandatory requirements. Although Flucelvax®/Optaflu® is currently indicated only for adults and the elderly, pediatric data indicate its good immunogenicity and safety. This paper provides an update on the clinical development of Flucelvax®/Optaflu®, its seasonal trials and available post-marketing surveillance data.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Manini
authors.forename: Alexander
authors.initials: A
authors.lastname: Domnich
authors.forename: Daniela
authors.initials: D
authors.lastname: Amicizia
authors.forename: Stefania
authors.initials: S
authors.lastname: Rossi
authors.forename: Teresa
authors.initials: T
authors.lastname: Pozzi
authors.forename: Roberto
authors.initials: R
authors.lastname: Gasparini
authors.forename: Donatella
authors.initials: D
authors.lastname: Panatto
authors.forename: Emanuele
authors.initials: E
authors.lastname: Montomoli
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D004285:Dogs; D004353:Drug Evaluation, Preclinical; D006801:Humans; D007252:Influenza Vaccines / Q000276:immunology* / Q000302:isolation & purification*; D007251:Influenza, Human / Q000517:prevention & control*; D061985:Madin Darby Canine Kidney Cells; D011358:Product Surveillance, Postmarketing; D013678:Technology, Pharmaceutical / Q000379:methods*; D014611:Vaccination / Q000379:methods*
chemical_list: D007252:Influenza Vaccines