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.

Manini, I., Domnich, A., Amicizia, D., Rossi, S., Pozzi, T., Gasparini, R., et al. (2015). Flucelvax (Optaflu) for seasonal influenza. EXPERT REVIEW OF VACCINES, 14(6), 789-804 [10.1586/14760584.2015.1039520].

Flucelvax (Optaflu) for seasonal influenza

MANINI, ILARIA;Domnich, Alexander;ROSSI, STEFANIA;POZZI, TERESA;MONTOMOLI, EMANUELE
2015

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.
Manini, I., Domnich, A., Amicizia, D., Rossi, S., Pozzi, T., Gasparini, R., et al. (2015). Flucelvax (Optaflu) for seasonal influenza. EXPERT REVIEW OF VACCINES, 14(6), 789-804 [10.1586/14760584.2015.1039520].
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11365/1010174