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.
“The past few months have really brought home to us all the importance of confidence in COVID-19 vaccines,” said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. “As mass vaccination campaigns continue to be rolled out, ICMRA and WHO reaffirm their commitment to support healthcare professionals and reassure members of the public that the regulatory processes for the authorisation and safety monitoring of COVID-19 vaccines are robust and driven by patient needs.”
In their joint statement, international regulators and WHO reiterate that COVID-19 vaccines undergo an extensive scientific evaluation to determine their safety, efficacy and quality. They also explain the measures put in place to allow regulators to collect emerging data on vaccine safety from a wide range of sources and to take swift regulatory action to protect public health whenever needed. ICMRA and WHO urge healthcare professionals to not only diligently report adverse events they see in their patients, but also to encourage people who are vaccinated to immediately report any side effects they might experience. This helps regulators to assess any possible link with the vaccines and ensure that the vaccines are used in the safest way.
- This press release, together with all related documents, is available on the Agency’s website at: www.ema.europa.eu
- More information on the work of the International Coalition of Medicines Regulatory Authorities (ICMRA) can be found on its website: http://www.icmra.info/drupal/