Pfizer-BioNTech Covid vaccine documents ‘unlawfully accessed’ in cyberattack on EU medicines regulator

Documents relating to the regulatory submission of the Pfizer-BioNTech Covid vaccine candidate to the European Medicines Agency (EMA) were “unlawfully accessed” during a cyberattack, the pharma firms have said.

The EMA confirmed earlier on Wednesday that it had been the subject of a cyberattack, but did not provide further details and said it would not do so while an investigation into the hack was ongoing.

In a joint statement, Pfizer and BioNTech said they were informed on Wednesday by the EU medicines regulator that “some documents relating to the regulatory submission for Pfizer and BioNTech’s Covid-19 vaccine candidate...which has been stored on an EMA server, had been unlawfully accessed.”

At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law. 

The pair added that none of their systems had been breached and that they were not aware of “any personal data of study participants being accessed."

“EMA has assured us that the cyberattack will have no impact on the timeline for its review” of the vaccine, they added, which is already being rolled out in the UK.

A day after the vaccine was first administered in the UK, the British medicines and healthcare regulator issued a warning about the administering of the jab, saying that two medics with a history of serious allergies had suffered severe reactions to it. The health agency said that people with a history of ‘significant’ allergic reactions should not receive it.

Canada became the second country to approve the vaccine on Wednesday.

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