Promoting confidence in COVID-19 vaccines
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have jointly developed a statement aimed to help healthcare professionals answer questions about the role of regulators in the oversight of COVID-19 vaccines and to reassure medical staff about the safety of COVID-19 vaccines that undergo a robust scientific evaluation to determine their quality, safety and efficacy. The statement outlines measures put in place nationally and globally to continuously monitor the safety of COVID-19 vaccines that are used in countries worldwide. It also contains up-to-date information on clinical trial data (including effectiveness studies), COVID-19 virus variants, commonly reported adverse events for each vaccine type as well as the latest advice on vaccine boosters and vaccine safety in children and pregnant women.
The development of the latest version of this statement, which was last updated in 2021, followed a series of discussions among ICMRA members and WHO on the importance of public confidence in COVID-19 vaccines.
Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 17 May 2022)
Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization [PDF]
Statement in other languages
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have jointly developed a statement to help healthcare professionals increase trust and confidence in COVID-19 vaccines and answer questions from patients about the development, regulatory review and safety monitoring of these vaccines.
Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 11 June 2021)
Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization [PDF]
Statement in other languages
ICMRA members from around the world have jointly developed a statement 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.
ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness (19 January 2021)
Statement in other languages
- Arabic - بيان التحالف الدولي للجهات الرقابية والموجه للمختصين الصحيين كيفية تنظيم (تشريع) لقاحات فيروس كوفيد 19 من منظوري السلامة والفاعلية.
- French - Déclaration de l’ICMRA pour les professionnels de la santé : Comment l’innocuité et l’efficacité des vaccins contre la COVID-19 seront réglementées
- Japanese - ICMRAの医療従事者向けステイトメント:COVID-19ワクチンの安全性及び有効性に関する規制方法
- Korean - 의료진 대상 ICMRA 성명: 안전성과 효과성을 위한 코로나19 백신 인허가 절차
- Portuguese - Declaração do ICMRA sobre confiança na eficácia e segurança das vacinas (para profissionais de saúde)