CBER Wants Better Vaccine Safety, Identify Adverse Events

| 03 May 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is announcing its intent to launch a program to ensure the safety of vaccine products manufactured around the globe by enhancing the regulatory capacity of emerging nations.

CBER's initiative, dubbed the "Global Regulatory Utilization of Vaccine Safety and Surveillance (GRUVSS) initiative," is in response to what FDA described as a "dramatic increase in the global use of vaccines, including new vaccines manufactured using novel technologies."

Because the manufacturing of these products is increasingly done abroad and outside the purview and expert watch of trained regulatory professionals, CBER said it will partner with a number of other agencies to put into motion its GRUVSS initiative, which it says "builds upon efforts currently underway."

The GRUVSS initiative operates with three goals in mind, said FDA in its explanation of the plan. It aims to "ensure the safety of people vaccinated" in low-and middle-income countries, enhance the regulatory capacity of countries manufacturing vaccines or introducing vaccines to their populations, and "support  countries through international collaboration, training and [the exchange of] information."

CBER said while the initiative will have a measurable impact on developing countries, it also serves the needs of US by proving FDA regulators with addition adverse event data, which may be useful in identifying advanced signals that a product is unsafe or needs changes made to its indication.

To put the GRUVSS initiative into motion, FDA said it will ramp up a number of new and existing initiatives, including the completion of an adverse event pilot project, the creation of a new pilot project with the World Health Organization to identify vaccine associations with Guillain-Barre syndrome, host several workshops and seminars and contribute to a number of existing global health initiatives.

FDA said it is "in discussion with the European medicines Agency (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."

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FDA - Global Regulatory Utilization of Vaccine Safety Surveillance (GRUVSS)