Aflunov®: a vaccine tailored for pre-pandemic and pandemic approaches against influenza

Abstract

Introduction: Aflunov is an egg-derived, subunit vaccine from Novartis Vaccines and Diagnostics containing 7.5 μg of hemagglutinin (HA) from the avian A/H5N1 virus and the oil-in-water adjuvant MF59.

Areas covered: Aflunov behaves as a pre-pandemic vaccine. It has a good safety profile at all ages. At all ages, it induces high and persisting antibody titers and activation of HA-specific Th0/Th1 CD4⁺ T cells, the levels of which correlate with the neutralizing antibody titers after a booster dose 6 months later. Aflunov triggers strong immunological memory, which persists for at least 6 – 8 years and can be rapidly boosted with a heterovariant vaccine strain, inducing very high neutralizing antibody titers within one week. These antibodies broadly and strongly cross-react with drifted H5N1 virus strains from various clades. Finally, the MF59 changes the pattern of HA recognition by antibodies that react with the HA1 more than with the HA2 region.

Expert opinion: The available data show that Aflunov is a pre-pandemic vaccine suitable not only for stockpiling in case of a pandemic, but also before a pandemic is declared, with the ultimate objective of preventing the onset of an influenza pandemic.

Keywords::

• Aflunov®
• influenza
• MF59®
• vaccine

Acknowledgments

Most of the data discussed in the paper have been obtained from clinical studies sponsored by Novartis Vaccines and Diagnostics. Some data, however, would have never been obtained without the exciting collaboration with investigators, universities, public health entities and governmental laboratories in many countries, with whom the authors had the pleasure to share the enthusiasm of generating novel data on influenza vaccines in general, and on pandemic influenza vaccines in particular. The authors want to collectively acknowledge here their contribution to what they know about Aflunov, and also to thank all the volunteers who patiently participated in the many clinical trials carried out with Aflunov. The authors would like to thank their colleagues at Novartis Vaccines and Diagnostics for the critical reading of the manuscript and for the constructive comments, Giorgio Corsi for the art work and Catherine Mallia for the editorial assistance.

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