The European Medicines Agency (EMA), which authorizes medicines for use across the European Union, has been hit by a cyber attack and documents relating to a COVID-19 vaccine have been accessed.
In a statement, EMA said it had launched a full investigation, in close cooperation with law enforcement and other relevant entities, which demonstrated that data has been breached. “An initial review revealed that a limited number of documents belonging to third parties were unlawfully accessed. The concerned companies are being informed.The Agency remains fully functional and its timelines related to the evaluation and approval of COVID-19 vaccines and treatments are not affected.”
Vaccine manufacturer BioNTech (Pfizer’s partner in the first vaccine to be given approval by the U.S. and U.K.) also posted a statement on its website on December 9:
“Today, we were informed by the European Medicines Agency (EMA) that the agency has been subject to a cyber attack and that some documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, which has been stored on an EMA server, had been unlawfully accessed. It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed. At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law. EMA has assured us that the cyber attack will have no impact on the timeline for its review.
“Given the critical public health considerations and the importance of transparency, we continue to provide clarity around all aspects of the vaccine development and regulatory processes. 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.”
INTERPOL has issued a global alert on the threat to the COVID-19 vaccination program, both physically and online. And IBM has already uncovered a global phishing campaign targeting the vaccine’s supply chain.
As well as the BioNTech/Pfizer vaccine, EMA is also assessing Moderna’s vaccine candidate. It is not clear whether or not Moderna documentation has been accessed as part of the cyber attack.
There is no reason to expect vaccine rollout to be delayed or paused (vaccination has already begun in the U.K.) as a result of the cyber attack.