The European Medicines Agency (EMA) reports 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, BioNTech revealed in a statement published on its website.
The German biotechnology company, previously best-known for its work pioneering cancer immunotherapy research, stressed that “no BioNTech or Pfizer systems” were accessed during the breach, suggesting that it was the European Union regulator whose security failed.
They added that they were “unaware” of any of their study participants being identified as a result of the breach and that they are awaiting “further information about EMA’s investigation and will respond appropriately and in accordance with EU law.”
“Our focus remains steadfast on working in close partnership with governments and regulators to bring our COVID-19 vaccine to people around the globe as safely and as efficiently as possible to help bring an end to this devastating pandemic,” they concluded.
The British National Cyber Security Centre (NCSC) has indicated that the hack should not impact the BioNTech/Pfizer vaccine’s rapid and at-times troubled rollout in the United Kingdom.
The Medicines and Healthcare products Regulatory Agency (MHRA) has advised that the coronavirus prophylactic should not be administered to people with a “history of a significant reaction” to medicines, foods, or vaccines, after two National Health Service (NHS) workers showed symptoms of an “anaphylactoid reaction” shortly after being injected.
The regulator now advised that “resuscitation facilities” should be present at all vaccination sites, and vaccinations not carried out if they are now available.
On the hacks, the NCSC said that it was “working with international partners to understand the impact of this incident affecting the EU’s medicine regulator, but there is currently no evidence to suggest that the UK’s medicine regulator has been affected.”
According to the BBC, it is “not clear” whether or not cyber-attackers also hacked the EMA’s documents on the Moderna vaccine at present.
China, Iran, and Russia have all been accused of using hackers against coronavirus vaccine research by Western governments.