The European Medicines Agency will not compromise on safety when giving its opinion on candidate vaccines against Covid-19. This was reaffirmed by the agency’s new Executive Director, Emer Cooke, in her first speech by videoconference to MEPs on the European Parliament’s Environment Committee on Thursday 10 December.
The Irish also confirmed the agency’s intention to submit its opinion on the applications for conditional authorisations of Pfizer-BioNTech and Moderna on 29 December and 12 January, respectively. However, she was unable to give a precise date for the other two vaccine candidates already undergoing continuous evaluation (Johnson & Johnson and AstraZeneca) in the absence of a marketing application by these two manufacturers.
“Promising” data
Ms Cooke indicated that the data provided by the pharmaceutical industry was comprehensive, covering the entire population, including the elderly population. According to her, the efficacy and safety appear very promising. “We have not seen adverse effects that would be a cause of concern, even within the elderly and patient with comorbidities”, she said, noting that her experts are currently reviewing the UK recommendations that the vaccine should not be given to people with severe allergies.
What is certain, she added, is that an authorisation will only be granted when it is proven that the benefits outweigh the risks. It will be valid for 1 year, renewable on an annual basis and may be withdrawn at any time.
“But what happens if a vaccine doesn’t work?” asked Jan Huitema (Renew Europe, the Netherlands). “Of course, we can’t guarantee there will be a positive outcome at this stage. If we could, we would have given it today”, said Ms Cooke, stressing that the analysis work was ongoing.
Relentless work
At the invitation of MEP Peter Liese (EPP, Germany), regretting the disinformation campaigns, the Executive Director recalled that the agency was working hard to fulfil its mission, stressing that its teams were working tirelessly, including taking shifts at night from 3 am.
She also highlighted EMA’s transparency efforts and, in particular, the conference with the public to be held on Friday 11 December. Aware of the current scepticism, she recalled that the agency would publish the full assessment report 3 days after the Commission’s decision whether or not to authorise a vaccine, and that it would publish all data related to clinical trials and risk management plans “as soon as possible”.
Finally, Ms Cooke returned to the cyberattack on EMA “in the last few weeks”. According to Pfizer, documents related to their application for authorisation (submitted with BioNTech) have been hacked. “The investigation is ongoing. I can assure this will not affect the timeline for delivery of vaccine and that we are fully functional”, Ms Cooke indicated. (Original version in French by Sophie Petitjean)