News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Johnson & Johnson intends to file for US Emergency Use Authorization (EUA) for its COVID-19 vaccine in early February, having reported the vaccine is 66% effective at preventing moderate to severe COVID-19.
The European Medicines Agency (EMA) today advised that AstraZeneca’s COVID-19 vaccine can be given conditional marketing authorization (CMA) in the EU to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
The EU Commission has published a redacted version of the contract it signed with AstraZeneca on COVID-19 vaccine delivery in August last year, in a bid to show that the pharma giant is backtracking on its commitments.
The Commission has today put in place a measure that requires companies it has secured COVID-19 vaccine deals with to notify the authorities in member states about any intention to export vaccines produced in the EU.
Novavax’s COVID-19 vaccine showed 89.3% efficacy in its Phase 3 UK trial: including against the UK variant. Meanwhile a Phase 2b trial suggests 60% efficacy against the South African variant. “Our vaccine is the first to demonstrate significant clinical...