Vaccine: Dr Chris Smith says ‘all medicines have a side effect’
Emer Cooke issued the alert after data was submitted to the European Medicines Agency (EMA) by Pfizer/BioNTech and Moderna. She added the data was “very robust”, but said there may not be a positive outcome. Ms Cook told a committee meeting of the European Parliament: “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.
“We cannot guarantee that there will be a positive outcome at this stage.
“We have to make sure we analyse those data correctly.”
The agency is expected to complete reviews of the application by December 29 for the Pfizer/BioNTech vaccine.
There will then be a decision by January 12 for the Moderna vaccine “at the latest”.
Ms Cooke added the approval decision dates could change, depending on the assessment.
She also said EMA analysts were checking data against the new information that emerged in the UK yesterday when two people had anaphylaxis and one a possible allergic reaction following the rollout of the vaccine began on Monday.
Ms Cook also believed AstraZeneca and Johnson & Johnson are likely to submit their applications for marketing authorisation of their COVID-19 vaccine candidates in the first quarter of next year.
The agency has been assessing preliminary data of the AstraZeneca jab since early October, and Johnson & Johnson’s data since early December.
It comes as Ms Cooke was also forced to send assurances that the EMA’s work assessing vaccines had not been disrupted by a cyberattack that took place in the past two weeks.
Pfizer and BioNTech said yesterday that documents related to the development of their COVID-19 vaccine had been “unlawfully accessed” in a cyberattack on the agency.
The EMA had revealed the attack had taken place hours earlier.
But they gave no details about when or how it took place, who was responsible or what information was compromised.
Ms Cooke said today: “We have been subject to a cyber attack over the last couple of weeks.
“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 coronavirus pandemic.
Attackers have ranged from state-backed spies to cyber criminals who are hunting for information.