Novel vaccine safety issues and areas that would benefit from further research

Vaccine licensure requires a very high safety standard and vaccines routinely used are very safe. Vaccine safety monitoring prelicensure and postlicensure enables continual assessment to ensure the benefits outweigh the risks and, when safety problems arise, they are quickly identified, characterise...

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Bibliographic Details
Published in:BMJ global health 2021-05, Vol.6 (Suppl 2), p.e003814
Main Authors: Salmon, Daniel A, Lambert, Paul Henri, Nohynek, Hanna M, Gee, Julianne, Parashar, Umesh D, Tate, Jacqueline E, Wilder-Smith, Annelies, Hartigan-Go, Kenneth Y, Smith, Peter G, Zuber, Patrick Louis F
Format: Article
Language:English
Subjects:
Analysis
Cardiac arrhythmia
Case studies
Communication
dengue
Dengue fever
Female
Health surveillance
Human papillomavirus
Humans
Infections
Influenza
Intestinal obstruction
Malaria
Meningitis
Mortality
Pain
Pandemics
Product life cycle
Public health
R&D
Research & development
Rotavirus
Rotavirus Vaccines
Safety
Sleep disorders
Tropical diseases
Vaccines
Vector-borne diseases
Viruses
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Summary:Vaccine licensure requires a very high safety standard and vaccines routinely used are very safe. Vaccine safety monitoring prelicensure and postlicensure enables continual assessment to ensure the benefits outweigh the risks and, when safety problems arise, they are quickly identified, characterised and further problems prevented when possible. We review five vaccine safety case studies: (1) dengue vaccine and enhanced dengue disease, (2) pandemic influenza vaccine and narcolepsy, (3) rotavirus vaccine and intussusception, (4) human papillomavirus vaccine and postural orthostatic tachycardia syndrome and complex regional pain syndrome, and (5) RTS,S/adjuvant system 01 malaria vaccine and meningitis, cerebral malaria, female mortality and rebound severe malaria. These case studies were selected because they are recent and varied in the vaccine safety challenges they elucidate. Bringing these case studies together, we develop lessons learned that can be useful for addressing some of the potential safety issues that will inevitably arise with new vaccines.
ISSN:2059-7908
2059-7908
DOI:10.1136/bmjgh-2020-003814