EU medicines regulator EMA 'targeted in cyberattack'

The European Medicines Agency (EMA) said on Thursday that it had been targeted in a cyberattack and was working with law enforcement to investigate it.

The agency said on Wednesday that "a full investigation" has been launched "in close cooperation with law enforcement and other relevant entities" after it was the subject of a cyberattack. It said it would not provide further information "whilst the investigation is ongoing."

No details were given as to when the attack took place, and it was not clear if any data was compromised.

A number of hacking attempts against healthcare and medical institutions have been reported during the coronavirus pandemic. US-based cyber-security firm Cybereason claimed in November that hackers from North Korea were targeting companies working on the research and development of Covid-19 vaccines. South Korean officials said at least one pharmaceutical company developing a Covid-19 vaccine was targeted, but there was no damage caused.

Microsoft has alleged Russian hackers were involved in similar activities, without giving evidence. Chinese hackers have also been accused of targeting US-based coronavirus vaccine research developer Moderna, in an alleged attempt to steal its data.

The EMA said last month that it is supporting the development of Covid-19 vaccines and has taken steps together with the European medicines regulatory network "to speed up the evaluation processes" for them. The agency is organizing a public meeting on December 11 to inform European citizens about the EU regulatory processes for the approval of vaccines and its role in their "development, evaluation, approval and safety monitoring."

On December 1, the EMA said it had received an application for conditional marketing authorization for a Covid-19 mRNA vaccine by Moderna Biotech Spain. It added that "the assessment of the vaccine… will proceed under an accelerated timeline" and an opinion on the marketing authorization of the jab could be issued within weeks.

The agency gave the same information regarding the application for authorization for a vaccine developed by BioNTech and Pfizer.

Meanwhile, the human medicines committee of EMA has also started a rolling review of a Covid-19 vaccine from Janssen-Cilag International, after receiving preliminary results from laboratory tests and early clinical studies in adults. The agency said that this rolling review would "continue until enough evidence is available for a formal marketing authorization application."

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