Enhancing vaccine safety capacity globally: A lifecycle perspective

Abstract

Major vaccine safety controversies have arisen in several countries beginning in the last decades of 20th Century. Such periodic vaccine safety controversies are unlikely to go away in the near future as more national immunization programs mature with near elimination of target vaccine-preventable diseases that result in relative greater prominence of adverse events following immunizations, both true reactions and temporally coincidental events. There are several ways in which vaccine safety capacity can be improved in the future to potentially mitigate the impact of future vaccine safety controversies. This paper aims to take a “lifecycle” approach, examining some potential pre- and post-licensure opportunities to improve vaccine safety, in both developed (specifically U.S. and Europe) and low- and middle- income countries.

A self-aggregating peptide: implications for the development of thermostable vaccine candidates

“…For this reason, in recent years new technologies have been developed to advance in the production of more efficient and safer vaccines [10,14,15]. Lowering the cost of vaccines is an essential step to facilitate massive vaccination especially in isolated areas where the cold-chain cannot be maintained easily [14,16].…”

Introducing new vaccines in low- and middle-income countries: challenges and approaches

“…There is also a need to develop new messaging strategies (as around disease syndromes or partial protection) [22]. The introduction of new vaccines for diseases endemic in LMICs without prior use in countries with strong pharmacovigilance systems requires specific safety monitoring strategies [23,24]. Post-licensure evaluation of vaccine safety, effectiveness or impact is associated with methodological challenges in low resource settings [25,26].…”

Vaccination and unexplained sudden death risk in Taiwanese infants

“…Because lot A constituted the majority of DTwP doses supplied beginning in July 1991, its suspension contributed to temporary vaccine shortages in Taiwan, and a decrease in DTwP doses administered was observed. The recent experience of other Asian countries with pentavalent vaccine (DTwP–HepB–Hib) use being associated with reports of deaths further highlights the need for establishing an infrastructure to timely evaluate safety signals, particularly when new vaccines are introduced in LMICs . In Taiwan, the ad hoc case–control results were not available until July 1995, approximately 3 years after the initiation of investigation, but use of linkable nationwide mortality and immunization datasets in 2015 efficiently shortened the hypothesis‐testing timespan to several months.…”

“…The recent experience of other Asian countries with pentavalent vaccine (DTwP-HepB-Hib) use being associated with reports of deaths 46 further highlights the need for establishing an infrastructure to timely evaluate safety signals, particularly when new vaccines are introduced in LMICs. 47,48 In Taiwan, the ad hoc case-control results were not available until July 1995, approximately 3 years after the initiation of investigation, but use of linkable nationwide mortality and immunization datasets in 2015 efficiently shortened the hypothesis-testing timespan to several months. Prospectively collected and assembled demographic, health outcome, and vaccination data can provide additional analytical flexibility to rapidly confirm or refute hypotheses should they occur.…”