Regulatory Priorities, Real-World Evidence, and the Safety and Effectiveness of COVID-19 Vaccines

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FDA's Sentinel Initiative Driving Sound Research Practices for Vaccine Development

The ways COVID-19 vaccines are being administered have changed substantially in the last few months. Issues such as mixing and matching vaccines, boosters, and vaccine use in children are fundamentally changing that landscape. These shifts make it critically important that research methods are solid; the Sentinel Initiative plays a key role in ensuring that in the US. 

The Sentinel Initiative, launched in 2007 by the US Food and Drug Administration (FDA), is a national electronic data system created to help monitor the safety of FDA-regulated products, including drugs, vaccines, biologics, and medical devices. Having a collective network of data providers and scientific collaborators enables regulators to evaluate potential safety issues rapidly.

The Sentinel system provides extensive health-data resources for safety surveillance, support for developing and applying new methods, and support for performing studies. The Biologics Effectiveness and Safety (BEST) System supports the Sentinel Initiative in monitoring the safety and effectiveness of biologic products. RTI-HS is in the trenches with CBER and other partners in the BEST System to address FDA regulatory priorities around new COVID-19 vaccines. 

RTI-HS is collaborating with the FDA to ensure that rigorous, valid methods are used to evaluate COVID-19 vaccine effectiveness in the real world. Bradley Layton, PhD, Senior Research Epidemiologist with RTI-HS, shares, “We are honored to be working with the FDA and their network of research collaborators committed to ensuring rigorous, valid research in service of public health and safety.”

Dr. Layton recently served as a panelist on the FDA Sentinel Initiative Public Workshop session BEST Collaborator Perspectives. The session focused on the BEST System’s work with partners to support COVID-19 pandemic efforts – particularly the development of vaccine safety and effectiveness protocols.

Layton reported that “BEST System scientific and data partners and leadership from CBER discussed the ongoing work of evaluating COVID-19 vaccine safety and effectiveness in the BEST System’s data resources. There have been exciting developments in building enhanced data capacity for rapid analyses, establishing novel linkages with vaccine registries, and investigating and applying cutting-edge methods for inferential studies. Panelists and moderators emphasized how lessons learned during the COVID-19 pandemic can prepare us to respond rapidly to future pandemics.”

 

 

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