Hackers access vaccines files at EU drug watchdog

Cybercriminals hacked into the European Medicine Agency (EMA) in December to steal key files related to COVID-19 vaccines, the agency has confirmed.

The attack targeted sensitive documents included data provided to the regulator by vaccine manufacturers. The companies concerned have been contacted and informed of the breach.

Investigations are ongoing but the EMA said it now believes that the data breach was limited to one IT application. The EU’s drug watchdog, in the spotlight as it reviews COVID-19 vaccines, has engaged a specialised third-party service provider to support the full investigation that is currently being carried out in close cooperation with law enforcement and other relevant entities.

The Agency and the European medicines regulatory network remain fully functional and timelines related to the evaluation and approval of COVID-19 medicines and vaccines are not affected.

To date, the EMA has approved two COVID-19 vaccines, developed by Pfizer/BioNTech and Moderna. Two more products, submitted by Oxford/AstraZeneca and J&J, are under rolling review. A decision on the Oxford/AstraZeneca vaccine could be made within weeks.

EU countries have been rolling out approved vaccines followed the green light from regulatory authorities. To avoid competition between European countries, the European Commission has concluded agreements with five vaccine manufacturers for millions of doses of vaccine. Doses are then distributed based on country size.

Europe is a few weeks behind the UK, US and Israel which were quicker to approve and deploy vaccines. Approval of the Oxford/AstraZeneca vaccine could accelerate coverage across Europe. Not only would it mean more doses were available, the vaccine is more easy to transport and store than the mRNA vaccines from Pfizer and Moderna.

While mRNA vaccines have proven to be more effective than other COVID-19 vaccines in clinical trials, and can be produced relatively swiftly, they are considerably more delicate and temperature-sensitive.

The J&J COVID-19 vaccine would add another option for health authorities. Its major attraction is that it could be approved as a single-dose vaccine rather than the two-dose schedule required of other COVID-19 vaccines. Not only might this mean protection is achieved more quickly, it reduces the administrative and logistical burden of calling people back for a second dose – and eliminates the risk that some people might not present for their second injection. The company is also testing a two-dose schedule.