tetano
Editor, Senior Moderator
xpert Rev Vaccines. 2015 May 12:1-16. [Epub ahead of print] [h=1]Flucelvax (Optaflu) for seasonal influenza.[/h] Manini I[SUP]1[/SUP], Domnich A, Amicizia D, Rossi S, Pozzi T, Gasparini R, Panatto D, Montomoli E.
[h=3]Author information[/h]
[h=3]Abstract[/h] 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[SUP]?[/SUP]/Optaflu[SUP]?[/SUP] (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.
[h=4]KEYWORDS:[/h] Flucelvax; MDCK cell culture; Optaflu; influenza vaccine; vaccination
PMID: 25968069 [PubMed - as supplied by publisher]
[h=3]Author information[/h]
[h=3]Abstract[/h] 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[SUP]?[/SUP]/Optaflu[SUP]?[/SUP] (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.
[h=4]KEYWORDS:[/h] Flucelvax; MDCK cell culture; Optaflu; influenza vaccine; vaccination
PMID: 25968069 [PubMed - as supplied by publisher]