Cyberattack on EMA - update 6

News 25/01/2021

Further to the cyberattack on EMA last year, some of the unlawfully accessed documents including email correspondence have been made public through the Internet and were subsequently picked up by some media outlets. This was the subject of a public update from the Agency on 15 January. A closer investigation of the published material has revealed that not all of the documents were published in their integral, original form and may have been taken out of context. Whilst individual emails are authentic, data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created and additional titles were added by the perpetrators in a way which could undermine trust in vaccines.

In the EU, several measures are in place to ensure the continued high quality of vaccines over their lifecycle. Vaccines used in public health immunisation programmes are subject to stringent testing and quality control measures and must meet rigorous specifications approved by EMA. Additionally, an official medicines control laboratory of a Member State performs an independent control for each batch of vaccine. 

The Agency continues to fully support the criminal investigation led by law enforcement authorities, in cooperation with other entities.

The Agency and the European medicines regulatory network remain fully functional and timelines related to the evaluation and approval of COVID-19 medicines and vaccines are not affected.

EMA will continue to provide information in due course, to the extent possible, given its duty towards the ongoing investigation.


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