Cyberattack: EMA says leaked documents ‘manipulated’

Regulatory NewsRegulatory News | 15 January 2021 |  By 

Documents related to COVID-19 vaccines that were unlawfully accessed in a cyberattack against the European Medicines Agency (EMA) and subsequently leaked online were intentionally manipulated, the agency said on Friday.
EMA first disclosed the hack in December and said at the time it had launched a full investigation in cooperation with law enforcement and other authorities. Since then, vaccine frontrunners Pfizer and BioNTech and Moderna have released statements acknowledging that documents related to their COVID-19 vaccine submissions were accessed.
Earlier this week, in its fourth update on the attack, EMA said it had learned that some of the documents that were accessed had been leaked online. (Updated: Documents leaked to the internet in wake of EMA cyberattack, Regulatory Focus 12 January 2021).
Now, in its latest update, EMA has disclosed that the leaked documents included internal confidential email correspondence from November relating to its 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,” EMA said.
EMA’s disclosure of the leak came one day after Italian cybersecurity firm Yarix said it found confidential documents related to the Pfizer-BioNTech vaccine on the dark web. The firm said it found a post on a forum containing more than 33 megabytes of files. Privacy and security expert Lukasz Olejnik tweeted what appears to be a screenshot of the leaked file directory and wrote that the manipulation of the documents point to an actor wanting to discourage vaccination by sowing disinformation about the integrity of the review process.
In its statement, EMA sought to assure that its review, while rapid and conducted with urgency, was not compromised. “Despite this urgency, there has always been a 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 also points out that it has released details of its scientific assessments for both vaccines on its website and the agency has committed to increased transparency for COVID-19-related products.


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