Hackers targeting the European medical regulator “unlawfully accessed” documents related to the Pfizer and BioNTech vaccine submission, the companies said in a statement.
The US drug giant and German firm said their own systems -- including personal data of participants -- had not been breached.
“We were informed by the European Medicines Agency (EMA) that the agency has been subject to a cyber attack and that some documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, which has been stored on an EMA server, had been unlawfully accessed,” a statement from BioNTech said Wednesday.
The company stressed that no BioNTech or Pfizer systems had been breached and they were “unaware that any study participants have been identified through the data being accessed.”
“At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law,” the statement said.
“EMA has assured us that the cyber attack will have no impact on the timeline for its review,” it added.
The EMA on Wednesday said it had launched a full investigation into the cyberattack and was in “close cooperation” with law enforcement officials and other relevant entities.
Neither the BioNTech nor EMA statement gave any further details on how the cyberattack took place or who was responsible.