EMA has endorsed a statement for healthcare professionals jointly developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO). The statement is 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.
ICMRA and WHO also highlight the measures put in place nationally and globally to continuously monitor the safety of COVID-19 vaccines that are used in countries worldwide.
“The COVID-19 vaccination campaigns have generated the largest set of information on vaccines, including real-world data from clinical practice, that we, the international community of regulators, have ever received,” said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. “The data clearly show you can trust the science – these vaccines work.”
The statement also contains up-to-date information as well as questions and answers on:
- clinical trial data (including effectiveness studies);
- COVID-19 virus variants;
- commonly reported adverse events for each vaccine type; and
- the latest advice on vaccine boosters and vaccine safety in children and pregnant women.
ICMRA and WHO will continue to monitor data on COVID-19 vaccines and their safety and provide any updates as they become available.
The development of the joint statement, which was last updated in January 2021, followed a series of discussions among ICMRA members and WHO on the importance of public confidence in COVID-19 vaccines. The ICMRA-WHO statement is available in English and French on the ICMRA and WHO websites.
ema.europa.eu
