Hackers target regulatory records for Pfizer's COVID-19 vaccine in Europe

Dec. 10 (UPI) -- European Union regulatory documents relating to the COVID-19 vaccine candidate made by Pfizer were "unlawfully accessed" by hackers, the pharma company's German biotech partner says.

BioNTech, which has been developing the vaccine with Pfizer, said it was informed by the European Medicines Agency that cyberattackers targeted regulatory documents that were submitted to the agency for the vaccine.

Pfizer and BioNTech are seeking EU approval for their BNT162b2 coronavirus vaccine candidate, which this week won approvals for use in Britain and Canada.

U.S. regulators are also expected to give emergency approval for the vaccine in the next few days.

"At this time, we await further information about EMA's investigation and will respond appropriately and in accordance with EU law," BioNTech said in a statement late Wednesday. "EMA has assured us that the cyber attack will have no impact on the timeline for its review."

The EMA said only that it had been the subject of a cyberattack.

"The Agency has swiftly launched a full investigation, in close cooperation with law enforcement and other relevant entities," the agency said in a statement.

BioNTech said the hacked documents had been stored on an EMA server and stressed that no BioNTech or Pfizer systems were breached and no data about the volunteers involved in clinical trials for the vaccine have been compromised.

"Our focus remains steadfast on working in close partnership with governments and regulators to bring our COVID-19 vaccine to people around the globe as safely and as efficiently as possible to help bring an end to this devastating pandemic," BioNTech added.

The hack is the latest to target COVID-19 researchers and healthcare providers struggling to cope with the pandemic.

In a Digital Defense Report released in September, Microsoft warned that more than a dozen "nation-state actors" have targeted global COVID-19 response efforts or leveraged the crisis to expand their credential theft and malware delivery tactics.

The attacks targeted prominent government healthcare organizations to monitor their networks or people, Microsoft's report said.

Security researchers at IBM said last week that hackers had launched a global "phishing campaign" to target organizations associated with cold supply chains for COVID-19 vaccines -- a vital component that ensures safe preservation of the vaccines in temperature-controlled environments during storage and transportation.

IBM's experts said the attack had the "potential hallmarks of nation-state tradecraft."