In order to to reinforce post-marketing surveillance  of the effectiveness, safety and effect of COVID-19 vaccines in Europe, a joint meeting was held by Joint Advisory Board (JAB) on 26th April this year. JAB is co-chaired by the European Medicines Agency (EMA) along with the European Centre for Disease Prevention and Control (ECDC) working to review the prioritisation, draft, conduct and clarification of the post-authorisation observational studies of the vaccine.

EMA and ECDC will mutually organize and supervise a number of large-scale, nation-wide, observational studies for close monitoring of new vaccines in real life. These studies will help produce sufficient evidence to support incessant evaluation of the risk-benefit ratio of COVID-19 vaccines and notify decision-making on their use in national or local vaccination schemes for diverse populations. EMA will work on saefty monitoring and EDC, the vaccine efficacy.

As stated by EMA’s Executive Director-Emer Cooke, ”Observational research is the mainstray of post-marketing investigation of COVID-19 vaccines and increased EU level partnership is required to organise large studies fulfilling both medicines regulators and national institutes needs for promoting public health and vaccination.“

The JAB will meet time and again to address the need for studies to inform vaccination approaches and significant regulatory measures on COVID-19 vaccines.