Ursula von der Leyen prepares Europe for the increased threat of variants
- 3 years ago
President of the European Commission, Ursula von der Leyen, said: “Our priority is to ensure that all Europeans have access to safe and effective COVID-19 vaccines as soon as possible. https://www.eudebates.tv/debates/eu-policies/health-eu-policies/ursula-von-der-leyen-admits-to-failings-in-vaccine-eu-plan/ At the same time, new variants of the virus are emerging fast and we must adapt our response even faster. To stay ahead of the curve, we are launching today the HERA Incubator. It brings together science, industry and public authorities, and pulls all available resources to enable us to respond to this challenge.”
#eudebates #Covid_19 #coronavirus #Corona #COVD19 #Health #COVID #vaccine #CureVac #Moderna #AstraZeneca
Commission is proposing 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” 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.
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:
- Detect, analyse and assess variants
Developing specialised tests for new variants, and to support genomic sequencing in Member States with at least €75 million in EU funding;
Reaching the target of 5% of genome sequencing of positive tests to help identify variants, monitor their spread in populations, and screen their impact on transmissibility;
Stepping up research and data exchange on variants with €150 million funding;
Launching the VACCELERATE COVID-19 clinical trial network, bringing together 16 EU 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.
- 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, such as amending the regulatory procedure to enable the approval of an adapted vaccine with a smaller set of additional data submitted to EMA on a rolling basis;
Providing guidance on data requirements for developers from the European Medicines Agency so that the requirements for variants are known in advance;
Facilitating certification of new or repurposed manufacturing sites through early involvement of regulatory authorities;
#eudebates #Covid_19 #coronavirus #Corona #COVD19 #Health #COVID #vaccine #CureVac #Moderna #AstraZeneca
Commission is proposing 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” 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.
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:
- Detect, analyse and assess variants
Developing specialised tests for new variants, and to support genomic sequencing in Member States with at least €75 million in EU funding;
Reaching the target of 5% of genome sequencing of positive tests to help identify variants, monitor their spread in populations, and screen their impact on transmissibility;
Stepping up research and data exchange on variants with €150 million funding;
Launching the VACCELERATE COVID-19 clinical trial network, bringing together 16 EU 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.
- 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, such as amending the regulatory procedure to enable the approval of an adapted vaccine with a smaller set of additional data submitted to EMA on a rolling basis;
Providing guidance on data requirements for developers from the European Medicines Agency so that the requirements for variants are known in advance;
Facilitating certification of new or repurposed manufacturing sites through early involvement of regulatory authorities;