BioNTech — a COVID-19 vaccine manufacturer in partnership with Pfizer — announced its regulatory submission was subject to a cyber-attack from the European Medicines Agency on Wednesday, according to a brief statement on the agency's website.
The hack is under investigation.
Pfizer/BioNTech vaccine documents were hacked
The European Medicines Agency (EMA) is working toward approving two COVID-19 vaccine candidates, expected to reach completion in two weeks, and the recent cyber-attack won't affect this timeline, according to BioNTech, the BBC reports.
The EMA didn't offer additional details on the extent or nature of the cyber-attack in a brief note on the hack on its website — except to say a full investigation was underway.
An agency spokesperson said it was still "functional," reports the BBC. But BioNTech said it was told documents relevant to the COVID-19 vaccine were accessed, in a different statement on its website.
BioNTech said hack will have 'no impact' on vaccine review timeline
"Today, we were informed [...] 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, BNT162b2, which has been stored on an EMA server, had been unlawfully accessed," said the company's statement.
"EMA has assured us that the cyber attack will have no impact on the timeline for its review," added BioNTech's release.
UPDATE Dec. 9, 3:20 PM EST: EMA investigating safety of Pfizer/BioNTech vaccine for E.U. member nations
Regarding the possibility of medical study participants' personal data security, BioNTech said it was "unaware" of any compromise. The EMA is responsible for authorizing medicines and vaccines across the entire European Union (E.U.)
At present, the EMA is investigating whether the Pfizer/BioNTech vaccine — which is still undergoing its initial rollout in the U.K., in addition to a different vaccine candidate from Moderna — is safe for use in E.U. member nations.
Whether Moderna's vaccine documents were also accessed has yet to be announced.
UPDATE Dec. 9, 3:26 PM EST: UK COVID-19 vaccine rollout remains unaffected, said country's cybersecurity center
This is the latest cyber-attack in a series of warnings of possible hacks against vaccine-developers, in addition to public health institutions.
In October, an India-based pharmaceutical company experienced a cyber-attack. Additionally, IBM recently said the cold storage supply chain — crucial for transporting viable vaccines — had already experienced cyber-attacks.
This latest hack comes one day before the European agency is slated to update the European Parliament on the progress made in assessing the vaccine.
The U.K.'s National Cyber Security Centre said no signs suggest the hack will alter the rollout schedule of the vaccine in the U.K., which began administering COVID-19 vaccines on Tuesday.
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