Monovalent inactivated split-virion AS03-adjuvanted pandemic influenza A (H1N1) vaccine

Abstract

The first cases of pandemic influenza A (H1N1) 2009 infection were seen in Mexico in March 2009. Since then, it is thought to have been responsible for at least 18,337 deaths globally. Owing to the young age of fatalities, there have been an estimated 2 million years of life lost, which is comparable to the previous pandemics of 1957 and 1968. In this article, we consider the available data on a monovalent inactivated split-virion AS03-adjuvanted pandemic influenza A (H1N1) vaccine, Pandemrix™ (GlaxoSmithKline, Rixensart, Belgium). At present, Pandemrix appears to be highly immunogenic in all age groups, including children and infants under 3 years of age, with an acceptable safety profile in the context of an influenza pandemic. However, owing to the novel adjuvant, further studies on the safety, immunogenicity and vaccine effectiveness of Pandemrix together with robust post-marketing surveillance are required.

Keywords::

• adjuvant
• AS03
• Guillain–Barré syndrome
• immunogenicity
• pandemic H1N1 influenza
• reactogenicity
• squalene
• swine flu
• thiomersal

Financial & competing interests disclosure

Woolf T Walker has acted as a sub-investigator on commercially funded investigator-led vaccine trials and on commercially funded and sponsored vaccine trials. Saul N Faust has acted as principal investigator for clinical trials conducted on behalf of Southampton University Hospitals NHS Trust and the University of Southampton sponsored by vaccine manufacturers (including GlaxoSmithKline), but received no personal payments from them. Saul N Faust has participated in advisory boards for and received funding to attend conferences from vaccine manufacturers (including GlaxoSmithKline) but has received no personal payments for this work. All grants and honoraria are paid into accounts within the NHS Trust or University. Neither Woolf T Walker nor Saul N Faust have any financial interest in this vaccine or manufacturer. 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.

No writing assistance was utilized in the production of this manuscript.