Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness
Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization
11 June 2021
The global impact of the COVID-19 pandemic has resulted in an unprecedented level of public interest in vaccines. This includes a focus on the development of vaccines and their regulatory review and safety monitoring.
The joint International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO statement aims to help healthcare professionals answer questions about the role of regulators in the oversight of COVID-19 vaccines.
The statement explains how vaccines undergo robust scientific evaluation to determine their safety, efficacy and quality and how safety is closely and continually monitored after approval.
Furthermore, the statement describes rare adverse events of special interest for mRNA vaccines (Pfizer and Moderna COVID.19 vaccines) and for adenovirus vector vaccines (AstraZeneca, Janssen, Gamaleya and CanSino Biologics vaccines) and advises healthcare professionals to closely monitor patients and promptly report suspicious side effects.
The section Questions and Answers on COVID-19 vaccines addresses issues such as rapid but thorough development of COVID-19 vaccines, plurality of candidate vaccines in development, speed of regulatory authorisation, and duration of protection, among others.
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 role in facilitating access to safe and effective high-quality medicinal products essential to human health and well-being. This includes ensuring that benefits of vaccines outweigh their risks.
ICMRA is an international executive-level coalition of key regulators from every region in the world. It provides a global strategic focus for medicines regulators and gives strategic leadership on shared regulatory issues and challenges. Priorities include coordinated response to crisis situations.
About the World Health Organization
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from 149 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.
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