German biotech firm BioNTech said that documents relating to the Covid-19 vaccine it has developed with Pfizer were “unlawfully accessed” after a cyber-attack on Europe’s medicines regulator.
Earlier, the European Medicines Agency (EMA), responsible for assessing and approving vaccines for the European Union, said it targeted a cyber-attack. It gave no further details.
Britain’s National Cyber Security Centre studied the situation and its impact on the UK, the first country where the Pfizer/BioNTech vaccine was deployed.
Following the disclosure, BioNTech said the EMA had informed it that “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”.
But, it added, “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.”
The EMA gave no further details about the attack, saying that it was investigating the incident with law enforcement help. “EMA cannot provide additional details while the investigation is ongoing. Further information will be made available in due course,” it said in a statement.