BRUSSELS (REUTERS) – The head of the European Union drug regulator said on Thursday (Dec 10) the agency’s work assessing Covid-19 vaccines had not been disrupted by a cyber attack that took place in the past two weeks.

US drugmaker Pfizer and its German partner BioNTech said on Wednesday documents related to the development of their Covid-19 vaccine had been “unlawfully accessed” in a cyber attack on the European Medicines Agency (EMA).

The EMA had disclosed the attack hours earlier but gave no details about when or how it took place, who was responsible or what information was compromised.

“We have been subject to a cyber attack over the last couple of weeks,” Ms Emer Cooke told EU lawmakers during a hearing on Thursday.

“I can assure you that this will not affect the timeline for delivery of vaccines and that we are fully functional.”

Pfizer and BioNTech said they did not believe any personal data of trial participants had been compromised and the EMA “has assured us that the cyber attack will have no impact on the timeline for its review”.

Hacking attempts against healthcare and medical organisations have intensified during the Covid-19 pandemic as attackers ranging from state-backed spies to cyber criminals hunt for information.

Meanwhile, Ms Cooke said the data submitted to the agency by Pfizer/BioNTech and Moderna for their Covid-19 vaccine candidates remains “very robust”.

“We have a data set of over 30,000 subjects who have been followed through the clinical trials. This gives us a very robust data set on which to make a decision, both on safety and efficacy,” Ms Cooke told the hearing.

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The agency is expected to complete reviews by Dec 29 for the Pfizer/BioNTech vaccine and by Jan 12 for the Moderna vaccine “at the latest”. Cooke said that the approval decision dates could change, depending on the assessment.

“We cannot guarantee that there will be a positive outcome at this stage” Ms Cooke said, adding that the agency’s experts had to examine very large data sets. “We have to make sure we analyse those data correctly.” 

EMA analysts were also checking data against the new information that emerged in Britain on Wednesday when two people had anaphylaxis and one a possible allergic reaction after the rollout of the Pfizer/BioNTech vaccine began.

Ms Cooke added that she expected AstraZeneca and Johnson & Johnson to submit in the first quarter of next year their applications for a marketing authorisation of their Covid-19 vaccine candidates. The agency has been assessing preliminary data of the AstraZeneca shot since early October, and Johnson & Johnson’s data since early December.

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