In a cyberattack on Europe’s medicines regulator, Pfizer and its German partner BioNTech said that documents related to coronavirus vaccine development on Wednesday had been “unlawfully accessed”.
The European Medicines Agency (EMA), which allows and approves medicines and vaccines for the Europen Union, said that it had been targeted in a cyberattack. It did not reveal any more details regarding the matter.
Moreover, Pfizer and BioNTech believed that no personal data of trial participants had been leaked and EMA “has assured us that the cyber attack will have no impact on the timeline for its review.”
It was not clear that when or how the EMA was attacked, or who was the culprit behind the cyberattack.
BioNTech spokeswoman had declined further comment and Pfizer also did not reply immediately to a request for more comment.
Both the companies said that they were instantly 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 that any study participants have been identified through the data being accessed.”
In its earlier statement, EMA had given few details about the cyberattack and said,
“EMA cannot provide additional details whilst the investigation is ongoing. Further information will be made available in due course.”
The UK had become the first country to approve Pfizer/BioNTech coronavirus vaccine for widespread use.
Britain’s medicines regulator, the MHRA, said the jab, which offers up to 95% protection against Covid-19 illness, is safe to be rolled out.