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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.

Go deeper

Jan 29, 2021 - Health

J&J says its one-shot vaccine is 66% effective against moderate to severe COVID

Photo: Thiago Prudêncio/SOPA Images/LightRocket via Getty Images

Johnson & Johnson announced Friday that its single-shot coronavirus vaccine was 66% effective in protecting against moderate to severe COVID-19 disease in Phase 3 trials, which was comprised of nearly 44,000 participants across eight countries.

Between the lines: The vaccine was 72% effective in the U.S., but only 57% effective in South Africa, where a more contagious variant has been spreading. It prevented 85% of severe infections and 100% of hospitalizations and deaths, according to the company.

Jan 29, 2021 - Health

WHO says most pregnant women can now receive coronavirus vaccine

A doctor administering Moderna's coronavirus vaccine at a university hospital in Essen, Germany, on Jan. 18. Photo: Lukas Schulze/Getty Images

The World Health Organization has altered its guidance for pregnant women who wish to receive the coronavirus vaccine, saying now that those at high risk of exposure to the COVID-19 or who have comorbidities that increase their risk of severe disease, may be vaccinated.

Why it matters: The WHO drew backlash for its previous guidance that did not recommend pregnant women be inoculated with vaccines made by Pfizer-BioNTech or Moderna, even though data indicated that pregnancy increased the risk of developing severe illness from the virus.