Cyberattack on EMA - update 5
The ongoing investigation of the cyberattack on EMA revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines have been leaked on the internet.
This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.
Two EU marketing authorisations for COVID-19 vaccines have been granted at the end of December/beginning of January following an independent scientific assessment.
Amid the high infection rate in the EU, there is an urgent public health need to make vaccines available to EU citizens as soon as possible. Despite this urgency, there has always been consensus across the EU not to compromise the high-quality standards and to base any recommendation on the strength of the scientific evidence on a vaccine’s safety, quality and efficacy, and nothing else.
EMA is in constant dialogue with the EC, and other regulators across the network and internationally. Authorisations are granted when the evidence shows convincingly that the benefits of vaccination are greater than any risks of the vaccine. Full details of the scientific assessments are publicly available in the European Public Assessment Reports on EMA’s website.
The Agency continues to fully support the criminal investigation into the data breach. Necessary action is being taken by the law enforcement authorities.
EMA will continue to provide information in due course, to the extent possible, given its duty towards the ongoing investigation.