Pharma Packaging

The Committee recommended granting a marketing authorisation for a new vaccine that provides active immunisation to prevent Ebola virus disease in individuals aged one year and older. The new Ebola vaccine consists of two components, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Zabdeno is given first and Mvabea is administered approximately eight weeks later as a booster. Zabdeno and Mvabea were evaluated under EMA's accelerated assessment mechanism, a tool which aims to speed up patients' access to new medicines if there is an unmet medical need.

At a virtual meeting with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party on Tuesday, 2 June 2020, the Agency presented an overview of its contribution to the pandemic response and provided updates on COVID-19 treatments and vaccines under development. In addition, the patients’ and healthcare professionals’ organisations heard about the work carried out by EMA and Member States on availability of authorised medicines. The PDF iconagenda of the virtual meeting is available. Recordings of each session of the meeting have also been made public:

Rapid scale-up The project Includes joint investment and tech transfer to prepare segregated and dedicated manufacturing capacity at Catalent’s Bloomington facility in Indiana to prepare for rapid scale-up and cGMP commercial manufacturing of the investigational vaccine candidate. Catalent plans to hire approximately 300 additional employees at the site for this program starting in July to meet operational readiness for 24×7 manufacturing by January 2021. The 875,000 sq.-ft.