PT  - JOURNAL ARTICLE
AU  - Salmon, Daniel A
AU  - Lambert, Paul Henri
AU  - Nohynek, Hanna M
AU  - Gee, Julianne
AU  - Parashar, Umesh D
AU  - Tate, Jacqueline E
AU  - Wilder-Smith, Annelies
AU  - Hartigan-Go, Kenneth Y
AU  - Smith, Peter G
AU  - Zuber, Patrick Louis F
TI  - Novel vaccine safety issues and areas that would benefit from further research
AID  - 10.1136/bmjgh-2020-003814
DP  - 2021 May 01
TA  - BMJ Global Health
PG  - e003814
VI  - 6
IP  - Suppl 2
4099  - http://gh.bmj.com/content/6/Suppl_2/e003814.short
4100  - http://gh.bmj.com/content/6/Suppl_2/e003814.full
SO  - BMJ Global Health2021 May 01; 6
AB  - 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.No data are available.