Pfizer, BioNTech COVID-19 vaccine documents hacked

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US-based drug manufacturer Pfizer and its German partner BioNTech say documents relating to the development of the COVID-19 pandemic have been hacked.

In a statement yesterday, the companies said: “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.”

The announcement comes one month after Pfizer and BioNTech revealed their vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.

The study enrolled 43 538 participants, with 42% having diverse backgrounds.

However, following the hack, the companies point out it is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and they 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 the cyber attack will have no impact on the timeline for its review,” the companies note.

They add that given the critical public health considerations and the importance of transparency, they will 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.”

In its own statement, EMA says: “EMA has been the subject of a cyber attack. The agency has swiftly launched a full investigation in close cooperation with law enforcement and other relevant entities.

“EMA cannot provide additional details whilst the investigation is ongoing. Further information will be made available in due course.”

Last week, ITWeb reported that cyber criminals are increasingly targeting companies and government organisations distributing COVID-19 vaccines.

This is according to IBM Security X-Force, which created a threat intelligence task force dedicated to tracking down COVID-19 cyber threats against organisations that are keeping the vaccine supply chain moving.

IBM Security X-Force urges companies in the COVID-19 supply chain – from research of therapies and healthcare delivery, to distribution of a vaccine − to be vigilant and remain on high alert during this time.

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