December 9, 2020
LONDON (Reuters) – German biotech firm BioNTech said on Wednesday that regulation documents related to the COVID-19 vaccine it is developing with Pfizer were “unlawfully accessed” after a cyberattack on Europe’s medicines regulator.
The European Medicines Agency – which is responsible for assessing and approving medicines, medical devices and vaccines for the European Union – said earlier on Wednesday it had been targeted in a cyberattack.
BioNTech said: “Today, 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 … had been unlawfully accessed.”
It 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.”
BioNTech said it was now waiting for further information about the breach.
The EMA gave no details about the attack in its earlier statement, saying only that it was investigating the incident with help from law enforcement.
“EMA cannot provide additional details whilst the investigation is ongoing. Further information will be made available in due course,” it said in a statement.
(Reporting by Pushkala Aripaka in Bengaluru and Jack Stubbs in London; Editing by Angus MacSwan and David Gregorio)
