Expert Review Vaccine Profiles

Including address, academic qualifications, and job titles of all authors, as well as telephone number, fax number and email address of the author for correspondence on a separate cover sheet as the peer reviewers will not be aware of the authors’ identity.
 
Please note that only the address of the first author of the article will appear on Medline/PubMed, not necessarily the corresponding author.

Maximum 200 words.

The aim of the abstract is to draw in the interested reader and provide an accurate reflection of the content of the paper. We therefore request the following structure is followed for full-length review articles:

– Introduction: Authors are required to describe the significance of the topic under discussion.
– Areas covered: Authors are required to describe the research discussed and the literature search undertaken.
– Expert opinion: The author’s expert view on the current status of the field under discussion.

A brief list of keywords, in alphabetical order, is required to assist indexers in cross-referencing. The keywords will encompass the therapeutic area, mechanism(s) of action, key components etc.

An executive summary of the authors’ main points (bulleted) is very useful for time-constrained readers requiring a rapidly accessible overview.

Introduction
Incorporating basic information on disease incidence and prevalence, unmet medical need and present treatment guidelines (highlighting regional variations where appropriate).

Overview of market
• What are the unmet needs of currently available therapies?
• Which competitor compounds/classes of compounds are in the clinic/late development?

Introduction to the vaccine
• Chemistry
• Pharmacodynamics
• Pharmacokinetics and metabolism

Clinical efficacy
• (Phase I studies)
• Phase II studies
• Summary table of Phase I and II trial results
• Phase III studies
• Summary table of Phase III trial results

Post- marketing surveillance (if applicable)
• Safety and tolerability. Including a table summarizing safety outcomes in clinical trials, and also a table comparing the characteristics of the vaccine with its competitors.

Regulatory affairs
• Include information on the status of the vaccine, i.e., where it is currently approved, in which countries it is approved and for what indications. Should cover EU, US and rest of the world where appropriate.

Conclusion
An analysis of the data presented in the review.

This section affords authors the opportunity to go beyond the conclusion and provide their interpretation of the data presented in the article, discussing any improvements the vaccine has over currently available therapies and how likely physicians are to convert to treatment with the vaccine. In addition, there is the opportunity to discuss the developments that are likely to be important in the future and the avenues of research likely to become exciting as further studies yield more detailed results, potential questions to consider are:

1. How could advances/research have discussed here impact real-world outcomes (diagnosis, treatment guidelines, effectiveness, economics, drug utilization etc.)? Can changes be realistically implemented into clinical/research practice? What is preventing adoption in clinical practice?
2. What are the key weaknesses/challenges in the field and how can current problems/limitations be solved? Are there any technical, technological, or methodical limitations that prevent research from advancing as it could?
3. What potential does further research hold? What is the goal in this field?
4. Does the future of study lie in this area? Are there other more promising areas in the field which could be progressed?
5. How will the field evolve in the future? In your perspective, what will the standard procedure have gained or lost from the current norm in five or ten years?

A brief summary to direct the reader to the most important further reading, related articles and relevant websites.

Important references should be highlighted with a one/two-star system and brief annotations should be given. Papers or patents of particular interest should be identified using one or two asterisk symbols (* = of interest, ** = of considerable interest) and annotated with a brief sentence explaining why the reference is considered to be of interest.