A U.S. Food and Drug Administration advisory panel is meeting Thursday to decide whether to recommend U.S. pharmaceutical company Pfizer Inc. and its German partner BioNTech SE's vaccine.
There were a record number of patients hospitalized with COVID in the U.S. at 106,000 Wednesday, according to official data as the two companies said materials associated with its vaccine development had been "unlawfully accessed" in a cyberbreach of Europe's drug regulator, the BBC reported Thursday.
Britain began to distribute the Pfizer/BioNTech two-dose coronavirus vaccine which Canada approved Wednesday.
The European Medicines Agency, which evaluates vaccines and other medicines for the European Union, is working on approval of two COVID treatments - which the agency expects to finalize soon. It confirmed the cyber-attack but gave no further details.
The agency didn't say when the breach occurred or whether hackers sought vaccine information, tried to damage the server with ransomware or had some other purpose.
Pfizer and BioNTech said personal information of trial subjects may not have been compromised and the agency had assured the vaccine makers that the attack "will have no impact on the timeline for its review."
The hack wasn't expected to affect the two companies, BioNTech said. A representative for the agency said the network was still "functional."
U.S. cybersecurity officials did not respond to requests for comment.
"We're talking sensitive information about the vaccine and its mechanism of action, efficiency, risks and known possible side effects," Reuters quoted Marc Rogers, founder of a volunteer group fighting pandemic-linked breaches, the CTI-League, as saying.
Studies of the BioNTech and Pfizer treatment recently found it was 95% effective at preventing COVID. The vaccine is pending authorization in the U.S. and European Union.
The agency is set to update the European Parliament on the progress of vaccine evaluations Thursday.
The respiratory disease has sickened over 68 million people around the world, based on a Reuters tally. More than 1.5 million people have died.
