EU Vaccine Agency Victim of Cyber-attack
December 14, 2020
head of the European Union’s medical agency confirmed Friday it had been the
subject of a cyberattack for the past two weeks but said it will not impact its
ongoing evaluation of COVID-19 vaccines.
The cyberattack was originally announced Wednesday, with the agency providing
few details. During an online meeting with the European Parliament, European
Medicines Agency (EMA) executive director, Emer Cooke, said the agency had
“launched a full investigation in close cooperation with the law enforcement
officials and other relevant entities.”
In a brief statement on its website, Pfizer partner BioNTech said it had been
informed that some of the documents related to regulatory submission for its
COVID-19 vaccine candidate, which has been stored on an EMA server, had been
“unlawfully accessed.” The company said it did not believe any personal data of
trial participants had been compromised.
Cooke said Friday, “We can assure you that the timelines for the evaluation of
the COVID-19 vaccines and treatments are not impacted. And the agency as you see
today continues to be fully functional."
Amsterdam–based agency is evaluating the Pfizer-BioNTech's COVID-19 vaccine
already approved by Britain and Canada, as well as the vaccine candidate from
Moderna. The agency said it will make a decision on conditional approval at a
meeting to be held by December 29, while a decision on Moderna's version should
follow by January 12.
Cooke said based on the data for the two vaccines so far, "the safety and
efficacy look very promising, and we have not seen the adverse events coming up
that would be a concern."
Earlier this week, Cooke said the vaccine developed by Oxford University and
AstraZeneca is also being considered but complete data for that vaccine has not
yet been submitted.
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