EU Regulators Launch Vaccine-Focused Pharmacovigilance Project

EU pharmacovigilance is expanding in a big way for vaccine products, the European Medicines Agency (EMA) has announced.

Under a new plan unveiled on 26 November 2013, EMA will be working with other regulatory bodies on a new five-year project known as the Accelerated Development of Vaccine Benefit-Risk Collaboration in Europe (ADVANCE), the intent of which is to better assess the risks and benefits of a vaccine throughout its lifecycle.

Unlike many drugs, vaccines are generally intended to be used in a large segment of the population. Due to limitations on trial sizes in premarket settings, the amount regulators know about the potential risks of a drug are limited as well. If, for example, the risk of an adverse event is just 1/20,000, even a 10,000-person clinical trial might not discover the risk before the vaccine is made available to consumers.

While manufacturers are already required to submit reports of adverse events, it can be difficult for fragmented regulators and other health authorities to piece together disparate signals to determine if a trend is in fact present.

That's where the ADVANCE project is set to come into play, EMA said. The project will involve EMA, the European Centre for Disease Prevention and Control, vaccine manufacturers, national public health and regulatory bodies and other outside experts.

"The goal of ADVANCE is to review, develop and test methods, data sources and procedures, which will guide the development of a European framework that can ultimately deliver data for the assessment of the benefits and risks of vaccines," EMA explained in a press statement.

"The role of the EMA in ADVANCE will be to develop and test guidance for the conduct and reporting of studies in this area," regulators added. "This best-practice guidance will include methodological standards, governance rules, a code of conduct and a communication strategy."

Participating vaccine manufacturers already include Pfizer, GlaxoSmithKline, Sanofi Pasteur, Takeda and Crucell Holland. Health authorities from Switzerland, Spain, France, Greece, Finland, Italy and the UK have signed on as well.

The project is expected to cost €10.7 million over five years, of which €5 million was contributed by the EU pharmaceutical trade group EFPIA.

EMA Press Statement