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Pfizer and BioNTech say hackers stole information about their coronavirus vaccine from the European Union’s drug regulator.
The European Medicines Agency confirmed Wednesday that it was hit with a cyberattack as it reviewed the two companies’ COVID-19 shot for possible approval later this month.
The agency did not reveal any details about the attack, but Pfizer and BioNTech said the hackers who carried it out “unlawfully accessed” documents related to their regulatory submission for the vaccine that has been stored on an agency server.
The drugmakers said they did not believe any participants in their clinical study of the vaccine had been identified as a result of the attack, which did not penetrate either company’s systems.
EU regulators also assured Pfizer and BioNTech that the hack would not affect their timeline for reviewing the vaccine, the companies said in a statement. The EMA plans to meet by Dec. 29 to decide whether to grant a conditional authorization for the shot, following similar approvals in the UK and Canada.
“At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law,” Pfizer and BioNTech said. “Given the critical public health considerations and the importance of transparency, we continue to provide clarity around all aspects of the vaccine development and regulatory processes.”
The disclosure followed warnings in recent months that hackers were trying to steal critical information about the various coronavirus vaccines being developed around the world.
Microsoft said last month that it had detected cyberattacks on several companies directly involved in the vaccine efforts that were traced to Russian and North Korean hackers.
Hackers are also going after companies that will likely play a role in the complex process of shipping COVID-19 vaccines around the globe, IBM researchers warned last week.