Perspectives on the future of postmarket vaccine safety surveillance and evaluation

Abstract

Strong, scientifically-based postmarket safety surveillance is critical to maintaining public confidence in vaccinations and reducing the burden from vaccine-preventable diseases. The infrastructure and scientific methods for postmarket safety surveillance have continuously improved over the last 30 years, with major enhancements in the last decade. Supporting and enhancing this system will continue to be important as the number of vaccines and people vaccinated expands globally.

Keywords::

• benefit-risk
• epidemiology
• genomics
• informatics
• pharmacovigilance
• surveillance
• vaccine safety

Financial & competing interests disclosure

This article reflects the views of the author and should not be construed to represent FDA's views or policies. This work was supported as part of the author's duties as an employee of the US FDA. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Vaccination will be more important than ever as a disease prevention strategy as more vaccines are introduced and more people are vaccinated globally.

• Vaccination is very safe but rare adverse effects do occur.

• Declining vaccine-preventable disease incidence leads to increased public demands for evidence of vaccine safety.

• Pathogenesis of many adverse events will become better understood and linked to specific genetic profiles aided by the collection of tissue samples in adverse event biorepositories.

• Personalized vaccination will become theoretically possible as the cost of generating genetic profiles is reduced.

• Postmarketing surveillance coupled with epidemiological studies are necessary to monitor vaccine safety in actual use and improvements in methods will continue.

• New technologies, especially informatics, internet and mobile communications, will be evaluated and integrated into vaccines safety surveillance system.

• Convergence of vaccine safety, drug safety and product quality surveillance systems will increase.

• Vaccines will become even safer and vaccination will thrive as a disease prevention strategy.