Hacked Documents on COVID-19 Vaccines Were ‘Manipulated,’ EMA Says

Internal European Medicines Agency (EMA) documents on pending approvals of COVID-19 vaccines were hacked and leaked online, the agency said last week.

“Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines,” the EMA said.

The Jan. 15 announcement followed a Jan. 11 statement by Yarix, an Italian cybersecurity firm, that it found stolen EMA documents in “50 files of classified information on the authorization and commercial process of the Pfizer-BioNTech vaccine” on the dark web, which hosts websites for illicit activity. The documents had been hacked on Dec. 9, Yarix said, adding that its discovery of the leak triggered an investigation by the Italian Postal Police.

The EMA said the leaked documents “included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines.” This was the agency’s fifth statement on the hack since it occurred.

Germany-based BioNTech said in December that the EMA had notified the company and Pfizer — its partner in developing one of the first approved COVID-19 vaccines — that documents related to their regulatory submission had been among those hacked. “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,” the German company said.

Moderna, the developer of another approved messenger RNA vaccine against COVID-19, also said documents related to its EMA regulatory submission had been hacked. — Martin Berman-Gorvine