Live attenuated influenza vaccine tetravalent: a clinical review

Abstract

Live attenuated influenza vaccine (LAIV) has been available as a trivalent formulation in the EU since 2012. Influenza B strains from two lineages have co-circulated outside Asia in Europe, Israel and North America since the early 2000s. The trivalent vaccine contained a single influenza B lineage virus chosen primarily on the basis of the previous year’s circulating lineage. Failure to align the vaccine virus with the circulating virus leaves even vaccinated patients, particularly children, at risk for infection with B viruses from the other lineage. Recently, a tetravalent formulation was approved and use will begin during the 2014–2015 influenza season. Approval of LAIV Tetra was based on the established efficacy and safety of trivalent LAIV and studies demonstrating similar immunogenicity between the trivalent and tetravalent vaccines. Addition of a fourth strain to the vaccine will address the issue of co-circulation of influenza B viruses and provide a broader range of protection.

Keywords:

• intranasal influenza vaccine
• live attenuated influenza vaccine
• tetra
• tetravalent

Financial & competing interests disclosure

EAF Simões has received grant funds from MedImmune to the University of Colorado Denver. AR Bandell is an employee of MedImmune and holds stock or stock options in AstraZeneca, the parent company of MedImmune. Medical writing assistance was provided by JE Fincke and A Wu, of Complete Healthcare Communications, Inc. (Chadds Ford, PA, USA) and funded by MedImmune. Assistance in formatting, table and graph development was provided by M Giannopoulos of Complete Healthcare Communications, Inc. and funded by MedImmune. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• Influenza places a high burden of disease on children; current recommendations in the USA and UK suggest routine influenza vaccination for healthy children.

• Influenza B is a substantial contributor to the disease burden, especially in children.

• Tetravalent live attenuated influenza vaccine (LAIV) addresses the issue of co-circulation of influenza B viruses and provides a broader range of protection.

• The tetravalent formulation of LAIV vaccine will be available in the EU for the first time during the 2014–2015 influenza season.

• The efficacy and safety of trivalent LAIV has been established in clinical trials. Approval of tetravalent LAIV was based on studies showing similar immunogenicity and safety between the trivalent and tetravalent formulations of the vaccine.

Notes