EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities (ICMRA) that urges all stakeholders, including vaccines researchers and investigators, academia, regulators and the pharmaceutical industry, to continue COVID-19 vaccine trials beyond the time when the pre-defined cases of COVID-19 disease for final analysis in a trial have been reached. This can provide important additional and more precise information on longer-term safety and efficacy of a vaccine against COVID-19.
‘The work of ICMRA in streamlining regulatory requirements for vaccines through global cooperation has supported the rapid development of COVID-19 vaccines,’ said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. ‘Vaccines will be a key component in overcoming COVID-19, and we must ensure that robust and convincing evidence is being generated to enable the continuous assessment of their benefits and risks.’
The development of a joint statement on continuation of vaccine trials followed a series of meetings and discussions among ICMRA members on regulatory requirements to enable rapid assessment and authorisation of vaccines against COVID-19.