The new coronavirus variants spreading all over the world represent a "shift of paradigm" in the fight against the virus, Ursula von der Leyen, president of the European Commission, said on Wednesday as she unveiled a new EU plan to fight these mutations.
The president also announced a second contract with Moderna for the purchase of 300 million doses. The first contract, signed last year, covered 160 million doses. She gave no details about the timeline for deliveries.
The EU plan to fight variants, called HERA Incubator, will be a public-private partnership, pooling knowledge from researchers, biotech companies, manufacturers, the health sector and public authorities and regulators.
In order to detect and analyse variants, like the ones present in the UK, Brasil and South Africa, Brussels will provide at least €75 million in EU funding for developing specialised tests for new variants and to support genomic sequencing in member states, as well as €150 million for stepping up research and data exchange on the mutations.
The European Commission also wants to speed the approval process for vaccines adapted to the variants so they can reach citizens at a greater speed.
To this end, Brussels leaves the door open for emergency authorisation with shared liability among EU countries. This would represent a break from the marketing authorisation procedure that the European Medicines Agency (EMA) has so far granted, putting the liability entirely on the pharmaceutical companies.
Another key action of the plan will focus on ramping up industrial production of vaccines by monitoring supply chains and addressing bottlenecks.
Brussels will update its vaccine contracts, known as Advance Purchase Agreements, to support the development of adapted vaccines. The plan specifies that this should be done "with a detailed and credible plan showing capability to produce vaccines in the EU, on a reliable timescale", in a veiled reference to the delays announced by AstraZeneca, which were caused due to problems in its Belgian plant.
"This should not prevent the EU from considering sources from outside the EU if needed, provided they meet the EU safety requirements," the Commission adds.
Additionally, Brussels intends to launch a clinical trial network with 16 member states and five associated countries, including Switzerland and Israel, to "exchange data and progressively also include children and young adults as participants in clinical trials".
HERA Incubator will be a first step for the establishment of the European Health Emergency Preparedness and Response Authority (HERA), one of the main pillars of the European Health Union that von der Leyen wants to build.
The new plan needs to be rubber-stamped by EU leaders, who will meet next week for a two-day video conference.