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Wednesday 09 December 2020 6:57 pm

Covid-19 vaccine data ‘unlawfully accessed’ in cyberattack on EU regulator

By: Hannah Godfrey

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Regulation documents related to the Covid-19 vaccine it is developing with Pfizer were “unlawfully accessed” after a cyberattack on Europe’s medicines regulator, biotech firm BioNTech has said.

The European Medicines Agency – which is responsible for assessing and approving medicines, medical devices and vaccines for the European Union – said earlier today it had been targeted in a cyberattack.

BioNTech said: “Today, we were informed by the European Medicines Agency 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 … had been unlawfully accessed.”

It added that “no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware of any personal data of study participants being accessed.”

BioNTech said it was now waiting for further information about the breach.

The EMA gave no details about the attack in its earlier statement, saying only that it was investigating the incident with help from law enforcement.

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

Today Canada became the second country to approve the Pfizer/BioNTech vaccine, following from the UK last week. 

People in the UK started being vaccinated yesterday, with Margaret Keenan, a 90-year-old grandmother, becoming the first person in the world to receive the Pfizer COVID-19 vaccine outside of a trial in Britain.

Read more

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