Europe steps up its readiness for increased threat of Covid-19 variants
To stay “ahead of the curve”, the EU is launching the HERA IncubatorEuropost , Brussels
Launching HERA Incubator, the Commission is proposing on Wednesday immediate move to prepare Europe for the increased threat of coronavirus variants. This new European bio-defence preparedness plan against Covid-19 variants will provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines, and ensure scaling up of manufacturing capacities.
It will do this coordinating with researchers, biotech companies, manufacturers and public authorities in the EU and globally to detect new variants.
Our priority is to ensure that all Europeans have access to safe and effective Covid-19 vaccines as soon as possible, EC President Ursula von der Leyen, told the press during a news conference. At the same time, new variants of the virus are emerging fast and we must adapt our response even faster, she said explaining that HERA Incubator, will help “to stay ahead of the curve”.
It rings together science, industry and public authorities, and pulls all available resources to enable us to respond to this challenge, von der Leyen stressed.
Talking for HERA, Stella Kyriakides, EU Commissioner for Health and Food Safety outlined that it can meet the dual challenge of addressing new variants and increasing own vaccine production capacity.
Thierry Breton, EU Commissioner for the Internal Market, stressed that Task Force for ramping-up vaccine production is already engaging on a daily basis with industry to better address and anticipate potential bottlenecks.
“With this increased cooperation, we will ensure that the industrial phase of vaccine production allows manufacturers to meet their commitments while anticipating our future needs and adjusting vaccine production to future variants”, the Commissioner said.
As the new variants continue to emerge and issues with scaling up vaccine production are arising, the EU executive says the HERA Incubator will serve as a blueprint for the EU's long‑term preparedness for health emergencies.
The key step to boost preparedness, develop vaccines for the variants and increase industrial production is to detect, analyse and assess variants.
For this purpose with at least €75m EU money will be developed specialised tests for new variants, and to support genomic sequencing in Member States.
The goal is to reach 5% of genome sequencing of positive tests to help identify variants, monitor their spread in populations, and screen their impact on transmissibility.
New clinical trial network, called Vaccerelate Covid-19 will be kicked off. In its framework 16 EU countries, plus Switzerland and Israel and three others will exchange data and progressively include children and young adults in addition to take part in clinical trials.
Regulatory approval of adapted vaccines will be speeded up based on the annual influenza vaccine model, the EU will provide accelerated approval for adapted Covid-19 vaccines. It will providing guidance on data requirements for developers from the European Medicines Agency so that the requirements for variants are known in advance.
For ramping up production of Covid-19 vaccines the EU will update or conclude new Advance Purchase Agreements to support the development of new and adapted vaccines through EU funding, with a detailed and credible plan showing capability to produce vaccines in the EU, on a reliable timescale.
This should not prevent the EU from considering sources from outside the EU if needed, provided they meet the EU safety requirements.
It will develop a voluntary dedicated licensing mechanism to facilitate technology transfer and also ensure the EU's manufacturing capacity by building up the “EU FAB” project, among the long list of actions proposed.