▶️ Watch the press conference by Commissioner @SKyriakidesEU on vaccine deliveries and on the export transparency scheme. #StrongerTogether https://t.co/iczvKiAiRm — European Commission 🇪🇺 (@EU_Commission) January 25, 2021 Last Friday, the company AstraZeneca surprisingly informed the Commission and the European Union Member States that it intends to supply considerably fewer doses in the coming weeks than […]
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human […]
European Commission authorises second safe and effective vaccine against COVID-19
The European Commission has granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by Moderna, the second COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed […]
European Commission authorises first safe and effective vaccine against COVID-19
The European Commission has granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by BioNTech and Pfizer, making it the first COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency […]
Commission and EIB provide CureVac with a €75 million financing for vaccine development and expansion of manufacturing
The European Investment Bank (EIB) and CureVac, a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on optimised mRNA, entered into a €75 million loan agreement to support the Company’s ongoing development of vaccines against infectious diseases, including its vaccine candidate CVnCoV aimed at preventing SARS-CoV-2 infections. El préstamo, además, apoyará los […]
European Commission unveils EU vaccines strategy
The European Commission has presented a European strategy to accelerate the development, manufacture and deployment of vaccines against COVID-19. An effective and safe vaccine against the virus is our best bet for a permanent solution to the pandemic. The Commission will support efforts to accelerate the development and availability of safe and effective vaccines within […]
H2020. Innovations to accelerate vaccine development and manufacture
Vaccination is one of the greatest achievements in healthcare. However, developing a vaccine remains costly, time-consuming, and risky. Advances in immunology, disease modelling, in silico modelling, including the analysis of big data and the application of machine learning (ML) artificial intelligence (AI), provide opportunities to innovate, de-risk and accelerate the vaccine-development process. Many of these […]
Global regulators map out data requirements for phase 1 COVID-19 vaccine trials
Global regulators have published a report presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The meeting report provides an overview of regulatory considerations related to COVID-19 vaccine development and data required for regulatory decision-making on two key points: Pre-clinical data […]
First vaccine to protect against Ebola
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ervebo (rVSVΔG-ZEBOV-GP), the first vaccine for active immunisation of individuals aged 18 years and older at risk of infection with the Ebola virus. “The CHMP’s recommendation is the result of many years of collaborative global efforts to find and develop new medicines […]