EMA Pushes For More EU Support For COVID-19 Vaccine Work
Agency Will Be Transparent On Assessment Process & Clinical Data
Preparing for the assessment and post-approval monitoring of COVID-19 vaccines is taking up a lot of resources at the EMA, which has called on the European Commission to provide more support for such activities. The agency has also confirmed that no data have yet been submitted for its planned rolling reviews of potential vaccines.
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With coronavirus cases again on the rise in many European countries, members of two EU parliamentary committees asked industry representatives to explain why details of COVID-19 vaccine supply agreements are being kept under wraps.
Coronavirus Notebook: EMA Expects First Vaccine Efficacy Data Soon, ACT-Accelerator Needs Urgent Funding
Talks are continuing on COVID-19 vaccine supply in the EU, with Pfizer/BioNTech’s BNT-162 the latest in the frame for the delivery of 200 million doses. The European Commission has also said that if the vaccines fail to perform, any money paid in advance purchase deals should go towards further research.
A new licensing route is to be introduced by the UK MHRA next year for products that meet specific criteria, such as treating life threatening conditions or rare diseases and where there is a significant patient need. At a webinar this week, an MHRA medical assessor looked at the requirements that products will have to meet to enter the new pathway.