The 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."
The 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.