Hackers posted confidential documents regarding COVID-19 medicines and vaccines on the internet after a data breach late last year at the European Medicines Agency.
Timelines related to evaluating and approving COVID medicines and vaccines haven't been affected, the EMA said in a statement on Tuesday. The agency said it remains "fully functional" and that law enforcement authorities are taking action on the data breach.
Caught up in the hack were some documents submitted by Pfizer Inc. and BioNTech SE during regulatory review of their vaccine, approved last month.
Pfizer shares fell 2 per cent in New York, with BioNTech's American depositary receipts down 4.3 per cent.
The EMA said it would notify any additional entities and individuals whose documents and personal data may have been subject to unauthorized access.
The agency signed off on a second vaccine, from Moderna Inc., earlier this month. Currently under review is a third vaccine developed by AstraZeneca Plc and the University of Oxford. The regulator has said its drugs advisory panel could issue an opinion on that shot by Jan. 29.
Pfizer and BioNTech said last month that some documents they submitted to the EMA were accessed in the hack. The companies said that none of their systems had been breached in connection with the incident.
Since the pandemic began, hackers have been accused of targeting companies and research institutions.
Cybersecurity researchers at International Business Machines Corp. disclosed that unknown hackers were targeting companies and government agencies involved in vaccine distribution. Microsoft Corp. said hackers in Russia and North Korea had targeted seven "prominent" companies working on vaccines and treatment research.