U.S. drugmaker Pfizer and its German partner BioNTech said on Wednesday that regulation documents related to their development of a COVID-19 vaccine had been “unlawfully accessed” in a cyberattack on Europe’s medicines regulator.
The European Medicines Agency (EMA), responsible for assessing and approving medicines and vaccines for the European Union, said hours earlier it had been targeted in a cyberattack.
It gave no further details. Pfizer and BioNTech said they were waiting for further information from the EMA, but the agency “has assured us that the cyber attack will have no impact on the timeline for its review.”
It was not immediately clear when or how the attack took place, who was responsible or what other information may have been compromised.
A spokeswoman for BioNTech declined further comment. Pfizer did not immediately respond to a request for further comment.
The two companies said in a joint statement that they had been informed by the 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 … had been unlawfully accessed.”
They added that “no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware of any personal data of study participants being accessed.”
