Pfizer and BioNTech say documents relating to their development of a COVID-19 vaccine were “ illegally accessed ” in a cyberattack on the European medicines regulator.
US drugmaker Pfizer and its German partner BioNTech said on Wednesday that documents relating to their COVID-19 vaccine development were “illegally viewed” in a cyberattack on the European drugs regulator.
The European Medicines Agency (EMA), which is responsible for evaluating and approving medicines and vaccines for the European Union (EU), said hours earlier it had been the target of a cyber attack. He gave no further details.
Pfizer and BioNTech said they do not believe the personal data of trial participants has been compromised and the EMA “has assured us that the cyber attack will not impact the timeline of its review.”
It was not immediately clear when and how the attack took place, who was responsible, or what other information might have been compromised.
A spokesperson for BioNTech declined to comment further. Pfizer did not immediately respond to a request for further comment.
The two companies said they had been informed by the EMA “that the agency has been the subject of a cyber attack and that certain documents relating to the regulatory submission of Pfizer and BioNTech’s COVID-19 vaccine candidate … have been illegally consulted.
They added that “no BioNTech or Pfizer systems were violated in this incident and we do not know that any study participants were identified from the data consulted.”
The development of Pfizer-BioNTech is among the main contenders in a global race to deploy a vaccine against COVID-19. It is already being administered in the UK, which last week approved the vaccine for emergency use.
But the Pfizer-BioNTech vaccine is still under review by the EU. The EMA said it would complete its review by December 29, although it said its schedule could be subject to change.
The EMA gave few details about the attack in its previous statement, saying only that it was investigating the incident with the help of law enforcement.
“The EMA cannot provide further details while the investigation is ongoing. More information will be available in due course, ”he said in a statement.
Hack attempts against medical and medical organizations have intensified during the COVID-19 pandemic as attackers ranging from state-backed spies to cybercriminals scramble to obtain the latest information on the outbreak.
Reuters news agency has previously documented how hackers linked to North Korea, Iran, Vietnam, China and Russia have been repeatedly accused of attempting to steal information about the virus and its potential treatments.