The European Medicines Agency (EMA) has been subject to a cyber attack and 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.
No BioNTech or Pfizer systems have been breached in connection with this incident and they are unaware that any study participants have been identified through the data being accessed.
A statement on the EMA website said “EMA has been the subject of a cyberattack. The Agency has swiftly launched a full investigation, in close cooperation with law enforcement and other relevant entities. EMA cannot provide additional details whilst the investigation is ongoing. Further information will be made available in due course.”
But further information was released on BioNTech’s website which indicated certain documents had been accessed.