Photographer: Oliver Bunic / Bloomberg
Photographer: Oliver Bunic / Bloomberg
Hackers have posted confidential documents on Covid-19 drugs and vaccines on the internet after a data breach at the end of last year at European Medicines Agency.
The deadlines for evaluating and approving Covid drugs and vaccines have not been affected, the EMA said in a document statement on Tuesday. The agency said it remains fully operational and law enforcement is taking action on the breach.
Some documents submitted by Pfizer Inc. and BioNTech SE during their vaccine regulatory review, approved last month. The EMA stated that it would notify any additional entities and persons whose documents and personal data could have been subject to unauthorized access.
Pfizer shares fell 2.2% in New York, with U.S. depository BioNTech’s earnings down 5.1%.
The EMA update on the breach came after an Italian cybersecurity firm, Yarix, said it had found pirated documents related to the authorization of the Pfizer-BioNTech vaccine and commercial processes on the so-called dark web.
An attacker posted a blog post there containing files from the EMA, including confidential e-mails related to the production and marketing of vaccines, Yarix CEO Mirko Gatto said in an interview. The screenshots and documents in the post referred to an EMA secure communications portal reserved for authorized personnel, Gatto said.
Italian authorities
Yarix has reported the problem to Italian authorities, the CEO said, but is not working directly with the EMA. The agency did not immediately respond to a request for comment on the company’s disclosures.
Pfizer and BioNTech said last month that some documents they submitted to the EMA had been accessed in the hack. The companies said none of their systems had been breached.
A Pfizer spokesman declined to comment beyond the initial December statement. A BioNTech representative did not immediately respond to requests for comment.
The EMA signed a second vaccine, from Moderna Inc., earlier this month. Currently under examination is a third vaccine, developed by AstraZeneca Plc and Oxford University. The regulator said its drug advisory group could issue an opinion on the shooting by January 29.
The EMA is also conducting an ongoing review of a potential vaccine from Johnson & Johnson, although a decision on this shot is further, because a large late-stage trial has not yet yielded results.
Since the pandemic began, government-aligned hackers, including Russia and China, have been accused of targeting companies and research institutions.
Cyber security researchers at International Business Machines Corp. revealed that unknown hackers targeted companies and government agencies involved in the distribution of vaccines. Microsoft Corp. said hackers in Russia and North Korea targeted seven “prominent” vaccine and treatment research companies.
(Updates with the comments of the Italian security company in paragraphs five to seven)