Novavax has announced a deal with Gavi, the Vaccine Alliance, to provide 1.1 billion cumulative doses of NVX-CoV2373, Novavax’ recombinant protein-based COVID-19 vaccine candidate, for the COVAX facility.
Per the Memorandum of Understanding, Novavax and Serum Institute of India will manufacture and distribute the vaccine doses globally.
COVAX, an initiative led by the Coalition for Epidemic Preparedness Innovations, the World Health Organization and Gavi is aiming to deliver 2 billion coronavirus vaccine doses in 2021. The initiative includes more than 190 participating economies.
Novavax' shot has yet to gain global emergency authorizations and is being studied in two ongoing pivotal phase 3 clinical trials: in the U.S. and Mexico, as well as in the UK. The Maryland-based vaccine maker has previously reported positive interim efficacy results from its phase 3 U.K. trial. Data indicated a 89.3% efficacy, with over 50% of cases attributable to the now-predominant UK variant. Clinical efficacy was also demonstrated in a phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa variant
Novavax also has a $1.6 billion deal with the U.S. government to provide 100 million doses. The drugmaker has been fraught with obstacles including recruitment issues and manufacturing delays. The company had to delay the start of its late-stage trial twice due to manufacturing issues. The first batches of Novavax’s candidate were made by Emergent BioSolutions, one of the biggest contract manufacturers involved in Operation Warp Speed’s efforts to mass-produce vaccines. But OWS moved Novavax’s candidate out of Emergent’s facility to make way for J&J’s vaccine candidate — forcing Novavax to turn to Fujifilm for production. Novavax then had to prove to the FDA it could it could scale up production at Fujifilm’s facility.