Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer's view

Autor: Dominique Rosillon, Sandrine Fontaine, Vincent Bauchau, François Haguinet, Marie-Noëlle Marenne, Corinne Willame, Hubert Buyse, Laurence Baril, Catherine Cohet
Rok vydání: 2016
Předmět:
medicine.medical_specialty
Drug Industry
media_common.quotation_subject
030231 tropical medicine
Population
Vaccines
Attenuated
Risk Assessment
Chickenpox Vaccine
03 medical and health sciences
0302 clinical medicine
Health care
Malaria Vaccines
medicine
Adverse Drug Reaction Reporting Systems
Humans
Technology
Pharmaceutical
Quality (business)
030212 general & internal medicine
Papillomavirus Vaccines
Vaccines
Combined
education
Risk management
media_common
education.field_of_study
Vaccines
Data collection
General Veterinary
General Immunology and Microbiology
business.industry
Public health
Vaccination
Public Health
Environmental and Occupational Health
Rotavirus Vaccines
Identification (information)
Infectious Diseases
Data access
Risk analysis (engineering)
Influenza Vaccines
Molecular Medicine
business
Measles-Mumps-Rubella Vaccine
Zdroj: Vaccine. 35(23)
ISSN: 1873-2518
Popis: Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure. The aim of this perspective paper is to describe the authors' experience in the design and conduct of twelve PASS that contributed to the evaluation of the benefit-risk of vaccines in real-world settings. We describe challenges and learnings from selected PASS of rotavirus, malaria, influenza, human papillomavirus and measles-mumps-rubella-varicella vaccines that assessed or identified potential or theoretical risks, which may lead to changes to risk management plans and/or to label updates. Study settings include the use of large healthcare databases and de novo data collection. PASS methodology is influenced by the background incidence of the outcome of interest, vaccine uptake, availability and quality of data sources, identification of the at-risk population and of suitable comparators, availability of validated case definitions, and the frequent need for case ascertainment in large databases. Challenges include the requirement for valid exposure and outcome data, identification of, and access to, adequate data sources, and mitigating limitations including bias and confounding. Assessing feasibility is becoming a key step to confirm that study objectives can be met in a timely manner. PASS provide critical information for regulators, public health agencies, vaccine manufacturers and ultimately, individuals. Collaborative approaches and synergistic efforts between vaccine manufacturers and key stakeholders, such as regulatory and public health agencies, are needed to facilitate access to data, and to drive optimal study design and implementation, with the aim of generating robust evidence.
Databáze: OpenAIRE
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