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JUST IN: Pfizer-BioNTech COVID-19 Vaccine Documents Hacked

JUST IN: Pfizer-BioNTech COVID-19 Vaccine Documents Hacked

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Documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate were “unlawfully accessed” during a cyberattack on the European Medicines Agency (EMA), Pfizer said Wednesday.

 

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“It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware of any personal data being accessed,” a statement said.

 

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“We await further information about EMA’s investigation and will respond appropriately and in accordance with EU law.

 

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“Given the critical public health considerations and the importance of transparency, we continue to provide clarity around all aspects of the vaccine development and regulatory processes.”

 

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The Amsterdam-based EMA has said the incident was being investigated, but did not specify when it took place or whether its work on Covid-19 was targeted.

 

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The Dutch national police high-tech crime team was involved in the probe into the cyberattack, but police gave no more information, the Dutch news agency ANP reported.

 

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The EMA’s role as the drugs regulator for the 27-nation EU means it has access to data on the safety and quality of medicines from clinical trials and lab tests from companies that apply for authorization.

 

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The agency has said it will give a decision on conditional approval for Pfizer-BioNTech’s Covid-19 vaccine at a meeting that will be held by December 29 at the latest, while a ruling on Moderna’s version should follow by January 12.

 

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The Pfizer-BioNTech vaccine, BNT162b2, has received emergency approval in Great Britain and Canada.

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The US Food and Drug Administration is holding a meeting on approval Thursday, with the green light expected in the days that follow.

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