SK bioscience has extended its partnership with Novavax to include the manufacture and supply of Novavax’s Omicron COVID-19 vaccine candidate, which could become available later this year.
A meeting of the FDA’s vaccines and related biological products advisory committee (VRBPAC) voted Tuesday to recommend that the agency grant Emergency Use Authorization (EUA) for Novavax’ COVID-19 vaccine.
The European Commission has granted conditional marketing authorisation to Novavax for its COVID-19 vaccine: making it the first protein-based COVID-19 vaccine in the EU.
Novavax has completed its rolling submission to the World Health Organization for emergency use listing (EUL) of NVX-CoV2373, its COVID-19 vaccine candidate.
Co-administration of Novavax’s COVID-19 vaccine candidate and an approved influenza vaccine induced robust immune responses, according to data from a clinical trial. “The findings suggest simultaneous vaccination may be a viable immunization strategy,”...
A UK study, which has been trialing the combination of Oxford-AstraZeneca and Pfizer vaccine doses, is now extending the program to include Moderna and Novavax vaccines.
GSK will help manufacture up to 60 million doses of Novavax’s COVID-19 vaccine from its facility at Barnard Castle in the UK, with doses to be distributed in the country.
Novavax has started sharing early clinical data for its COVID-19 vaccine with health authorities in the UK, EU, US and Canada as it starts the rolling review process in these jurisdictions.
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...
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New Zealand now has enough COVID-19 vaccines for everyone in the country, says the government, as it announces two new supply agreements with Novavax and AstraZeneca today.
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Novavax’s COVID-19 vaccine. Novavax plans to start Phase 3 trials for the candidate in the US and Mexico by the end of the month.
Novavax’s Phase 3 COVID-19 vaccine trial in the UK has been expanded to 15,000 participants; while a 30,000 strong Phase 3 clinical trial is due to start in the US and Mexico next month.
Aiming to boost the gene therapy development and manufacturing capabilities of Paragon, which Catalent acquired in April, the CDMO has agreed to acquire all of the gene therapy-related assets from Novavax, a late-stage vaccine developer.