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New scientific forum and joint work launched for
monitoring safety and effectiveness of COVID-19 vaccine in Europe.
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.
EMA
EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe
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