Vaccines, Blood & Biologics
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.
FDA’s Center for Biologics Evaluation and Research (CBER) seeks to respond to this need by launching its Global Regulatory Utilization of Vaccine Safety and Surveillance (GRUVSS) Initiative. The GRUVSS Initiative builds upon efforts currently 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:
• Will complete a pilot project 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. Resources permitting, the pilot will serve as a foundation
for follow-on collaborations with UMC.
• Will assist WHO in building upon a pilot project that was initiated at the time of the H1N1 pandemic and
employed a new surveillance tool to detect any vaccine associated Guillain–Barré syndrome (GBS)
cases; this tool will now be piloted in both low- and middle-income countries.
• Will host 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. Resources permitting, the goal is to host the
seminar on an annual basis.
• 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.
• Is pursuing a sole-source Cooperative Agreement with the WHO to advance efforts envisioned under
• Is in discussion with the EMA to launch an exchange of information on validated signals between the
EMA and FDA/CBER for biological and related medicinal products which are the responsibility of
FDA/CBER and have been authorized in the European Union through the centralized procedure.
• Will contribute to a Pan American Vaccine Safety Network whose establishment is under discussion
within the Americas region.
• Support WHO initiatives to globally strengthen regulatory capacity and regulatory science in
• Support the WHO’s Global Advisory Committee for Vaccine Safety.
• Participate in consultations with the Bill and Melinda Gates Foundation on improving global