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ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness
Statement from the International Coalition of Medicines Regulatory Authorities
EMA has endorsed the joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help healthcare professionals answer questions about the evaluation, approval and monitoring of safe, effective and high-quality COVID-19 vaccines.
This International Coalition of Medicines Regulatory Authorities (ICMRA) statement aims to inform and help healthcare professionals answer questions about the role of regulators in the oversight of COVID-19 vaccines. It explains how vaccines undergo robust scientific evaluation to determine their safety, efficacy and quality and how safety will continue to be closely monitored after approval.
People who are not vaccinated remain at risk of spreading the virus. Herd immunity through vaccination occurs when the majority of population has been vaccinated and can no longer give the virus to others, hence protecting themselves as well as those who cannot be vaccinated. Achieving ‘herd immunity’ and reducing the effective reproduction number of infection disease as much as possible is important. If ‘herd immunity’ is not achieved by enough people being vaccinated this could seriously affect vulnerable people, including immunocompromised people who cannot receive vaccines, or those who respond poorly to vaccination and therefore are more readily infected. Herd immunity requires a combination of high vaccination coverage with vaccines that are both effective and provide a reasonable duration of protection. Achieving ‘herd immunity’ will allow a return to normal societal functioning and re-opening of economies.
ICMRA brings together the heads of 30 medicines regulatory authorities* from every region in the world, with the WHO as an observer. Medicines regulators recognise their important role in facilitating the provision of access to safe and effective high-quality medicinal products that are essential to human health and well-being. This includes ensuring that the benefits of vaccines outweigh their risks.