Flexibility in the labelling and packaging requirements is expected to reduce transport costs and storage space, improving the distribution of the doses between Member States and limit possible impact on the production of other routine vaccines. In order to allow for a rapid deployment of COVID-19 vaccines at large scale, the Commission has developed, with Member States and the European Medicines Agency, labelling and packaging flexibilities for a temporary period. Depending on the platform technology used, the time needed to make such changes may vary from 3-4 months up to 6-9 months. We believe that it should be possible to have amended vaccines developed and approved rapidly.We also hope that newer technologies such as mRNA vaccines could make the adaptation of existing vaccines even easier.Continued health safety measures will also continue to be key for a foreseeable future, so is testing and contact tracing to block transmission chains. Currently, the vaccines authorised within the EU appear to provide protection against the variants that are prevalent across the EU.But adapted vaccines still need to meet the EMA’s data requirements as laid out in its new guidance and EMA carries out a rolling review. For instance, data requirements are reduced and data can be complemented later. To ensure more flexibility, the Commission amended the regulatory procedure to accelerate approvals, building on what already exists for influenza vaccines. Other contracts, with other companies, may follow. The negotiations were launched on 14 April and we hope to conclude them very rapidly. And it will entail that not only the production of the vaccines, but also all essential components, will be based in the EU. This contract will foresee the delivery of 1.8 billion doses of vaccine over the period of 2021 to 2023. mRNA vaccines are a clear case in point.īased on all this, and as President of the European Commission Ursula von der Leyen announced on 14 April, the Commission is now entering into a negotiation with BioNTech-Pfizer for a third contract. Having this in mind we need to focus on technologies that have proven their worth. We will need them early and in sufficient quantities.If escape-variants occur, we will need to develop vaccines that are adapted to new variants.
It is clear that to defeat the virus decisively, we will need to be prepared for the following challenges: To prepare for the future, we are drawing the lessons from the first phase of our answer to the pandemic.
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