Johnson and Johnson’s experimental two-stage vaccine for protection against Ebola virus disease is among eight medicines backed by the European Medicines Agency’s human medicines committee (CHMP) at its May meeting.
The vaccine, developed by J&J group Janssen, provides active immunisation to prevent Ebola virus disease (Zaire ebolavirus species) in individuals aged one year and older.
It consists of two components, Zabdeno (Ad26.ZEBOV), which is given first, and Mvabea (MVA-BN-Filo), given around eight weeks later.
Zabdeno and Mvabea received a positive opinion for marketing authorisations under exceptional circumstances ‘because the applicant was able to demonstrate that it is not possible to conduct a randomised controlled study that might generate comprehensive clinical data on the efficacy of the new Ebola vaccine even after authorisation’, the agency noted.
Elsewhere, the following medicines also took giant leap closer to EU approval:
By: Selina McKee
Source: Pharma Times
The Serum Institute of India (SII) expects to soon receive World Health Organisation (WHO) emergency use authorisation for the Oxford University/AstraZeneca Covid-19 vaccine, produced for mid and low-income countries.
According to the deal, Sanofi will gain full global rights to Kymab’s fully human monoclonal antibody, KY1005 that attaches to OX40-Ligand and can potentially treat various immune-mediated diseases and inflammatory ailments.
Moderna tapped veteran Amgen executive Corinne Le Goff to spearhead that effort as chief commercial officer.