Current Approaches in Postapproval Vaccine Safety Studies Using Real-World Data: A Systematic Review of Published...

Area of Science:

• Vaccine safety research
• Pharmacovigilance
• Real-world data (RWD) analytics

Background:

• Postmarketing observational studies using real-world data (RWD) are crucial for vaccine safety evidence and public trust.
• Systematic review of current methodologies, technological advancements, and their limitations in vaccine safety research.

Purpose of the Study:

• To present current research methodologies in postapproval vaccine safety studies.
• To highlight technological advancements enhancing vaccine safety research resources and capabilities.
• To summarize the strengths and limitations of existing vaccine safety research approaches.

Main Methods:

• Comprehensive PubMed search from January 1, 2019, to December 31, 2022.
• Summarized eligible studies by design, country, vaccine, data source, and population.
• In-depth review of select studies representing novel designs, analytical approaches, and data collection methods.

Main Results:

• 135 articles reviewed out of 977 screened.
• Advancements in scientific methods, digital technology, and analytics significantly improve RWD-based vaccine safety studies.
• Near real-time surveillance, self-controlled designs, AI, NLP, and social media analysis enhance signal detection and outcome accuracy.

Conclusions:

• Continued development of RWD methodologies for vaccine safety research is essential.
• Future vaccine safety research will integrate digital technologies, linked RWD networks, machine learning, and advanced analytics.
• These integrated approaches will enable rapid and robust real-world safety information generation, particularly for rare events.