BBC: Pfizer/BioNTech vaccine docs hacked from European Medicines Agency

The European Medicines Agency (EMA) says it has been hit by a cyber-attack and documents relating to a Covid-19 vaccine have been accessed.

BioNTech, which makes one of the vaccines in partnership with Pfizer, said its regulatory submission was accessed during the attack.

The EMA is working on approval of two Covid-19 vaccines, which it expects to conclude within weeks.

The cyber-attack was not expected to impact that timeline, BioNTech said.

The EMA did not provide any details on the nature of the cyber-attack in a brief statement on its website, beyond saying a full investigation had been launched.

A spokesperson for the agency said it was still “functional”.

But BioNTech, in a statement published on its website, said it had been told its documents had been accessed.

“Today, we were informed… 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 said.

“EMA has assured us that the cyber-attack will have no impact on the timeline for its review,” it added.

It said it had made the details of the hack public “given the critical public health considerations and the importance of transparency”.

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