FDA’s safety initiatives for vaccines

Vaccines, pharmacovigilance, fda


Vaccines are a hot topic at the moment. This drug group offers plenty of R&D opportunities pharma. The increase in the global use of vaccines has highlighted the need to improve global vaccine pharmacovigilance. I have been working through some of the FDA's safety pages and have come across one focussing on the Global Regulatory Utilization of Vaccine Safety Surveillance (GRUVSS).


It focuses on the CBER's efforts with the GRUVSS Initiative.  It explains, "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."


Its worth taking a look at these pages as a useful source of information and solid reminder of key initiatives and regulations when planning your safety strategy for the US market. Vaccines will be part of the focus of the pre conference workshop day at the World Drug Safety Cognress Europe in September which is addressing the safety challenges for biologics.

Leave a Reply

Your email address will not be published. Required fields are marked *