Pfizer-BioNTech vaccine documents were ‘unlawfully accessed’ in a cyberattack on Europe’s medicines agency

LONDON —Documents related to the development of the Pfizer-BioNTech Covid-19 vaccine have been “unlawfully accessed” in a cyberattack on the European Medicines Agency.

The EMA said in a short statement on its website on Wednesday that it “has been the subject of a cyberattack” and launched an investigation “with law enforcement and other relevant agencies.”

The regulator did not disclose details on the nature of the attack but BioNTech said on its website that documents included in its regulatory submission, which were stored on an EMA server, had been accessed. It’s unclear exactly which documents were accessed and who by.

“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,” BioNTech said.

The German biotech firm said it had decided to release details of the hack “given the critical public health considerations and the importance of transparency.”

The EMA, which authorizes the use of medicines across the European Union, is currently reviewing two Covid-19 jabs. One is from Pfizer and BioNTech, and the other is made by Moderna. It is unknown if Moderna documents were also accessed.

The regulator is expected to announce a decision on whether the vaccines are safe for use across Europe in the coming weeks.

“EMA has assured us that the cyberattack will have no impact on the timeline for its review,” BioNTech said.