EU drugs regulator says limited number of documents accessed in cyberattack

The regulator said it would continue to provide more information in due course. The European Union has been waiting for the EMA to approve the vaccine from Pfizer and BioNTech.

Europe's medicines regulator said on Friday an investigation had so far revealed that a limited number of third-party documents were unlawfully accessed in a recent cyberattack and that it had engaged an external agency to carry out a full probe.

U.S. drugmaker Pfizer and German partner BioNTech said on Dec. 9 that documents relating to their COVID-19 vaccine were accessed unlawfully after the European Medicines Agency (EMA) disclosed the incident on the same day. The EMA, which assesses medicines and vaccines for the European Union, said it remained fully functional and its timelines related to the evaluation and approval of COVID-19 vaccines and treatments were not affected.

Pfizer and BioNTech had earlier said they did not believe any personal data of trial participants was compromised. The regulator said it would continue to provide more information in due course.

The European Union has been waiting for the EMA to approve the vaccine from Pfizer and BioNTech. The regulator is expected to make an announcement on Dec. 21.