Pfizer BioNTech vaccine paperwork “illegal entry” within the EMA hack

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A man will receive the first of two Pfizer / BioNTech Covid-19 stitches on December 8, 2020 at Guy’s Hospital in London.

Victoria Jones | AFP | Getty Images

LONDON – Documents related to the development of the Pfizer-BioNTech Covid-19 vaccine were “illegally accessed” in a cyberattack on the European Medicines Agency.

The EMA said in a brief statement on its website on Wednesday that it was “the subject of a cyberattack” and has opened an investigation “with law enforcement and other relevant authorities”.

The regulator did not disclose details of the nature of the attack, but BioNTech announced on its website that documents contained in the regulator’s filing and stored on an EMA server were accessed. It is unclear exactly which documents were accessed and by whom.

“It is important to note that no BioNTech or Pfizer systems were breached in connection with this incident, and we do not know that study participants were identified through access to the data,” BioNTech said.

The German biotech company said it had decided to release details of the hack “given the critical public health considerations and the importance of transparency”.

The EMA, which approves the use of medicines across the European Union, is currently reviewing two Covid-19 shocks. One is from Pfizer and BioNTech, the other from Moderna. It is not known whether Moderna documents were also accessed.

The regulator is expected to announce a decision in the coming weeks on whether the vaccines are safe across Europe.

“EMA has assured us that the cyberattack will not affect the schedule for its review,” said BioNTech.

Hackers target vaccine

Last week, IBM researchers announced that hackers had also attempted to attack the cold store supply chain that transports vaccines at low temperatures. The researchers warned that a nation-state would likely be behind the effort.

Security officials said in July that hackers linked to Russian intelligence services were attempting to steal information about coronavirus vaccine research in the US, Canada and the UK. Kremlin spokesman Dmitry Peskov denied the allegations, according to the state news agency TASS.

The UK’s National Cyber ​​Security Center said: “The NCSC supports the research and manufacture of essential vaccines to defend against cyber threats.”

“We are working with international partners to understand the impact of this incident on the EU Medicines Agency. However, there is currently no evidence that the UK Medicines Agency is affected.”

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