Dec 9, 2020 - Health

Pfizer-BioNTech vaccine data hacked from European Medicines Agency breach

A nurse in London prepares a dose of Pfizer-BioNTech's COVID-19 vaccine on Dec. 8.

A nurse in London prepares a dose of Pfizer-BioNTech's COVID-19 vaccine on Dec. 8. Photo: Frank Augstein/POOL/AFP via Getty Images

BioNTech and Pfizer announced Wednesday the European Medicines Agency was targeted by a cyberattack and regulatory documents related to their coronavirus vaccine submission were accessed.

Why it matters: The EMA is currently working to authorize coronavirus vaccines for use in European Union member states, and said it is launching an investigation into the attack. The hack is the latest in a series of attacks and warnings about cyber threats against vaccine-producers and public health agencies.

What they're saying: "It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed," BioNTech and Pfizer said.

  • The EMA noted it made the specifics of the attack public "given the critical public health considerations and the importance of transparency."

The big picture: The companies said the EMA assured them that the breach is not expected to impact the timeline for the review of their vaccine candidate.

  • The United Kingdom approved the vaccine last week and began administering doses this week.
  • The United States is expected to authorize the vaccine after the FDA's vaccine advisory committee found it appears to meet the safety and efficacy requirements necessary for an emergency use authorization.
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