AuthorsStern, Peter L
AffiliationUniversity of Manchester, UK
MetadataShow full item record
AbstractOBJECTIVE: The goal of a vaccine is to prime the immune response so the immune memory can facilitate a rapid response to adequately control the pathogen on natural infection and prevent disease manifestation. This article reviews the main elements that provide for the development of safe and effective vaccines Data Sources: Literature covering target pathogen epidemiology, the key aspects of the functioning immune response underwriting target antigen selection, optimal vaccine formulation, preclinical and clinical trial studies necessary to deliver safe and efficacious immunization. STUDY SELECTIONS: Whole live, inactivated, attenuated or partial fractionated organism based vaccines are discussed in respect of the balance of reactogenicity and immunogenicity. The use of adjuvants to compensate for reduced immunogenicity is described. The requirements from preclinical studies, including establishing a proof of principle in animal models, the design of clinical trials with healthy volunteers that that lead to licensure and beyond are reviewed. RESULTS: The three vaccine development phases, preclinical, clinical and post licensure integrate the requirements to ensure safety, immunogenicity and efficacy in the final licensed product. Continuing monitoring of efficacy and safety in the immunized populations is essential to sustain confidence in vaccination programs. CONCLUSION: In an era of increasing vaccine hesitancy the need for a better and widespread understanding of how immunization acts to counteract the continuing and changing risks from the pathogenic world is required. This demands a societal responsibility for obligate education on the benefits of vaccination, which as a medical intervention has saved more lives than any other procedure.
CitationStern PL. Key Steps in Vaccine Development. Ann Allergy Asthma Immunol. 2020.
JournalAnnals of Allergy Asthma and Immunology
- Reduced-antigen, combined diphtheria, tetanus and acellular pertussis vaccine, adsorbed (Boostrix®): a review of its properties and use as a single-dose booster immunization.
- Authors: McCormack PL
- Issue date: 2012 Sep 10
- Needle size for vaccination procedures in children and adolescents.
- Authors: Beirne PV, Hennessy S, Cadogan SL, Shiely F, Fitzgerald T, MacLeod F
- Issue date: 2015 Jun 18
- The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines.
- Authors: Lopalco PL, DeStefano F
- Issue date: 2015 Mar 24
- Use of interleukin 12 to enhance the cellular immune response of swine to an inactivated herpesvirus vaccine.
- Authors: Zuckermann FA, Martin S, Husmann RJ, Brandt J
- Issue date: 1999
- Strategic priorities for respiratory syncytial virus (RSV) vaccine development.
- Authors: Anderson LJ, Dormitzer PR, Nokes DJ, Rappuoli R, Roca A, Graham BS
- Issue date: 2013 Apr 18