On Wednesday, February 17, the European Commission has proposed immediate action to prepare Europe for the increased threat of coronavirus variants – the new European bio-defence preparedness plan against COVID-19 variants called “HERA Incubator”, as was reported by the press service of the European Commission.
The European "HERA (Health Emergency Response Authority) Incubator" will work with researchers, biotech companies, manufacturers and public authorities in the EU and globally to detect new variants, provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines, and ensure scaling up of manufacturing capacities.
According to the president of the European Commission, Ursula Gertrud von der Leyen, taking action now is important as new variants continue to emerge and challenges with scaling up vaccine production are arising. The HERA Incubator will also serve as a blueprint for the EU's long‑term preparedness for health emergencies.
Key actions to boost preparedness, develop vaccines for the variants and increase industrial production
1. Detect, analyze and assess variants
This includes the development of specialized tests for new variants, the support of genomic sequencing in the Member States with at least €75 million in EU funding; the launch of the ACCELERATE COVID-19 clinical trial network, identification of the new variants and monitoring of their spread.
2. Speed up regulatory approval of adapted vaccines
Based on the annual influenza vaccine model, the EU will provide accelerated approval for adapted COVID-19 vaccines by adapting the regulatory framework, providing guidance on data requirements for developers from the European Medicines Agency, facilitating certification of new or repurposed manufacturing sites through early involvement of regulatory authorities; considering a new category of emergency authorisation of vaccines at EU level with shared liability among the Member States.
3. Ramp 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, work closely with manufacturers to help to monitor supply chains, support the manufacturing of additional vaccines addressing new variants; develop a voluntary dedicated licensing mechanism to facilitate technology transfer; support cooperation between undertakings; ensure the EU's manufacturing capacity by building up the “EU FAB” project.
According to the statement, all these measures will prepare the ground for the European Health Emergency Preparedness and Response Authority (HERA). HERA will build on the actions launched today and provide a permanent structure for risk modelling, global surveillance, technology transfers, manufacturing capacity, supply chain risk mapping, flexible manufacturing capacity and vaccine and medicine research and development.
As was earlier reported by Apostrophe, scientists from the Cambridge Institute of Immunology said that coronavirus is likely to mutate during the treatment which involves transfusion of plasma.