European Medicines Agency says extra resources will be ‘critical’, while promising robust scrutiny of treatments
The European Medicines Agency has warned it is facing an “unprecedented increase in volume of work” in relation to the amount of side-effect monitoring it will have to do if it approves a plethora of vaccines and treatments for Covid-19.
Before that, “there is a need to prepare for a sharp rise” in applications to market treatments and vaccines, the agency said in a summary of a meeting of its management board it published on 5 October.
This increase is expected in the final quarter of 2020 and the first half of 2021, but the agency said it is “already diverting resources away from other important European public health activities”, such as drafting guidelines for product development.
It said that at the meeting its board “stressed it is critical that extra resources are urgently made available to EMA to allow the agency to fulfil its public health mandate and respond to patient needs in all disease areas”.
The agency said it has begun rolling reviews of data on two candidate Covid-19 vaccines: one being developed by AstraZeneca and the University of Oxford, and the other being developed by BioNTech and Pfizer.
The urgent need for a Covid-19 vaccine has prompted concerns worldwide that corners may be cut. In a published September response to a July inquiry from the European Ombudsman, the EMA said it was “taking measures so it can conduct evaluations of Covid-19 medicines as rapidly and efficiently as possible while maintaining high standards of safety, efficacy and quality”.
The agency said it would publish its full approval report for any Covid-19 vaccine, setting out how it was assessed, within three days of the European Commission issuing a final authorisation decision. It also said it was doing its best to separate its work advising companies from its regulatory arms.