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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Global Regulatory Utilization of Vaccine Safety Surveillance (GRUVSS)

Globalization has introduced many new challenges to the FDA in meeting its responsibility to assure that the products it regulates are safe, effective and of good quality.  This is true in the vaccine arena as well, where there has been a dramatic increase in the global use of vaccines, including new vaccines manufactured using novel technologies.  Multiple entities operating in the global public health arena have recognized the need to improve global vaccine pharmacovigilance in the wake of this changing landscape to assure vaccine safety.  Recent efforts highlight this need, specifically:

• The World Health Organization’s (WHO’s) Global Vaccine Safety Blueprint (“Blueprint”),
• The Decade of Vaccines (“DoV”),
• The FDA/US Agency for International Development’s (USAID’s) Report on the Safety of Medicines in Sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance (a product of the FDA/USAID Interagency Agreement on Strengthening Systems to ensure Quality and Safety of regulated products in developing countries (SSA), and
• The Report of the Council for International Organizations of Medical Sciences (CIOMS)/WHO Working Group on Vaccine Pharmacovigilance.

In seeking to respond to this need, FDA’s Center for Biologics Evaluation and Research (CBER) launched its Global Regulatory Utilization of Vaccine Safety and Surveillance (GRUVSS) Initiative on April 30, 2012.  The GRUVSS Initiative builds upon efforts that were already underway, as well as initiating activities in collaboration with other FDA components, US government agencies, and global partners such as the WHO and the Uppsala Monitoring Centre (UMC).  FDA/CBER hopes to be able to contribute to the mission outlined by the WHO in its Blueprint:

• To ensure the safety of people vaccinated by assisting low- and middle-income countries to have at least a minimal capacity for vaccine safety activities.
• To enhance capacity for vaccine safety assessment in countries that introduce newly available vaccines and countries that manufacture and use prequalified vaccines.
• To support countries through international collaboration, training and information exchange.

While the goal of strengthening global vaccine pharmacovigilance is to improve global public health, US public health would also be served.  US licensed vaccines are now increasingly used globally, and utilization of information from a more data rich environment can assist CBER in enhancing its adverse event signal detection.  Additionally, more vaccines are entering the global market prior to coming to the US for licensure.  Good signal detection can facilitate CBER’s pre-market safety assessment of such vaccines.

To this end, FDA/CBER:

• Has completed a pilot project in 2012 with the UMC to characterize the differences between vaccine adverse event reports in the UMC vaccine adverse event reporting database,  VigiBase, originating from VAERS and vaccine adverse event reports in VigiBase from other national centers, with the goal of maximizing the utilization/analysis of the combined data. Based on this pilot project, CBER’s Division of Epidemiology started using in 2012, FDA data mining methods in conjunction with VigiBase to examine the utility of this information for surveillance of CBER regulated vaccines with substantial worldwide distribution. 
• Is assisting WHO in building upon a pilot project that was initiated at the time of the H1N1 pandemic which employed a new epidemiological study approach to detect any association between pandemic influenza vaccines and Guillain–Barré syndrome (GBS) cases.  That study approach used an active, collaborative hospital-based vaccine safety monitoring methodology.  WHO, with FDA technical and financial support, began implementing the approach in a selected group of low and middle income countries in 2012.  It is anticipated that the methodology will become an integral part of WHO's vaccine safety monitoring toolbox.
• Hosted a two-day seminar June 2-3, 2012, in Uppsala, Sweden, following the WHO UMC course, “Pharmacovigilance:  the study of Adverse Drug Reactions and Related Problems” to explore the methods used by FDA/CBER scientists to assess post-marketing safety data and inform subsequent regulatory actions taken for vaccines and other biologics.  Based on positive feedback, this seminar, “Application of Pharmacovigilance to U.S. FDA Regulatory Decisions for Vaccines,” was integrated into the WHO UMC course in 2013.
• Offered a working session on vaccine pharmacovigilance within a broader USAID supported pharmacovigilance workshop targeting Sub-Saharan Africa held in Kenya in April 2012 to provide tools to assist countries in implementing a systems perspective to pharmacovigilance.  Resources permitting, the session is intended to serve as a platform for additional future workshops to provide hands-on experience by regulatory authorities in developing countries.
• In 2012, CBER entered into a sole-source Cooperative Agreement with the WHO to advance efforts envisioned under the Blueprint. 
• In 2013, a monthly exchange of validated signals was initiated between the EMA Patient Health Protection Sector and FDA/CBER Division of Epidemiology for products authorized in the European Union through the centralized procedure which are also regulated by CBER.
• Supports the Council for International Organizations of Medical Sciences CIOMS/WHO Working Group on Vaccine Pharmacovigilance by providing an expert on pharmacovigilance methods for a three year (2013-2016) effort to develop harmonized tools and methods for the exchange of vaccine safety information.  This project will build upon the prior report from the CIOMS/WHO Working Group on Vaccine Pharmacovigilance entitled “Definition and Application of Terms for Vaccine Pharmacovigilance” which established a common concepts and terms for vaccine pharmacovigilance.
• Supports WHO initiatives to global strengthen regulatory capacity and regulatory science in pharmacovigilance.
• Supports the WHO’s Global Advisory Committee for Vaccine Safety.
• Participates in consultations with the Bill and Melinda Gates Foundation on improving global pharmacovigilance.