Documents relating to Pfizer and BioNTech’s COVID-19 vaccine regulatory submission were accessed by cyber attackers, BioNTech confirmed in a statement on Wednesday.

European medicine regulator, the European Medicines Agency (EMA), on whose server the documents had been stored as part of its ongoing assessment for a Conditional Marketing Authorization to potentially enable use of the vaccine in Europe, was targeted by hackers.

“It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed.”


It added: “EMA has assured us that the cyber attack will have no impact on the timeline for its review.”

A full investigation has been launched by the EMA, in cooperation with law enforcement and other entities, the Agency said, though it was unable to provide more information while the investigation remains ongoing.

Commenting on the incident, the NCSC said: “We are working with international partners to understand the impact of this incident affecting the EU’s medicine regulator, but there is currently no evidence to suggest that the UK’s medicine regulator has been affected.”