Influenza vaccine failure: failure to protect or failure to understand?

ABSTRACT

Introduction: I propose that influenza vaccine failure be defined as receipt of a properly stored and administered vaccine with the subsequent development of documented influenza. Several mechanisms of vaccine failure occur and can – sometimes in combination – lead to what is termed ‘vaccine failure.’ Influenza vaccine failure occurs for many reasons, many of which are not true failures of the vaccine (e.g. improper vaccine storage/handling).

Areas covered: In this article, I discuss common causes of ‘vaccine failure’ that are appropriately or inappropriately attributed to vaccines. This includes host, pathogen, vaccine, and study design issues such as genetic restriction of immune response; failure to store, handle, and administer vaccine properly; issues of immunosuppression and immunosenescence; apparent but false vaccine failure; time-mediated failure; etc.

Expert commentary: A proper framework and nosology for vaccine failure informs discussion about influenza vaccine efficacy and prevents misperceptions that in turn affect vaccine uptake. Influenza vaccine can only provide maximum protection to the extent that the circulating and vaccine strains closely match; the vaccine is stored, handled, and administered properly and within a time frame to result in development of protective levels of immunity; and it is administered to a host capable of immunologically responding with protective immune responses.

KEYWORDS:

• Vaccine storage
• immunity
• immunization programs
• influenza
• human
• influenza vaccines
• vaccination

Declaration of interest

G Poland is the chair of a Safety Evaluation Committee for novel investigational vaccine trials being conducted by Merck Research Laboratories. Dr. Poland offers consultative advice on vaccine development to Merck & Co. Inc., Avianax, Adjuvance, Alopexx, Sanofi Pasteur, GlaxoSmithKline, and Emergent Biosolutions. G Poland holds four patents related to vaccinia and measles peptide research. These activities have been reviewed by the Mayo Clinic Conflict of Interest Review Board and are conducted in compliance with Mayo Clinic Conflict of Interest policies. This research has been reviewed by the Mayo Clinic Conflict of Interest Review Board and was conducted in compliance with Mayo Clinic Conflict of Interest policies. Research reported in this publication was supported by the National Institute of Allergy And Infectious Diseases of the National Institutes of Health under award number U01AI089859. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The author has 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.

Reviewer disclosures

A reviewer on the manuscript has disclosed receipt of research funding from Merck & Co., Inc. and Pfizer Inc. Another reviewer disclosed employment with Sanofi Pasteur, which manufactures influenza vaccine. In the manuscript, there was specific reference to at least 2 of the influenza vaccines that Sanofi Pasteur manufactures.

Additional information

Funding

Research reported in this publication was supported by the National Institute of Allergy And Infectious Diseases of the National Institutes of Health under award number U01AI089859. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.