In 2019, Novavax nearly closed down after bad management and failed vaccine trials. Today, they are one of the leading companies recognized in developing a coronavirus vaccine.
In September, their coronavirus vaccine candidate, NVX-CoV2373, began late-stage clinical trials in the United Kingdom. The United States and Mexico will also be entering phase three within the month.
As a small company of have less than 200 employees at the beginning of the year, they received funding from the Coalition for Epidemic Preparedness Innovations and was chosen for the government's Operation Warp Speed. At the same time, they have been advancing their flu vaccine NanoFlu and are working on getting approval from the U.S. Food and Drug Administration.
Developing a Coronavirus Vaccine
Work on the Covid-19 vaccine began shortly after Chinese researchers openly published the genome sequence of the virus in early January. R&D president Gregory Glenn and his team worked on developing their own version of the coronavirus spike protein. Out of more than 20 versions, the most stable was an antibody-inducing protein that was similar to the stage of the virus right before it fused with the host cell.
Lab tests confirmed that the engineered protein attached to the human cell receptor. Next, researchers used electron microscopy to assess how stable the protein structure was. Tests revealed that the engineered spike protein was stable for weeks between 35.6°F and 46.4°F. The temperature range is an advantage over major vaccines that need to be stored between -4°F and -94°F and only last a few days after being thawed.
To develop the NVX-CoV2373, the team used a baculovirus (DNA virus that infects insect) to insert a Covid-19 spike protein into moth cells. The spike proteins were then harvested from the moth cells and mixed with synthetic particles. An immune-boosting adjuvant derived from soap bark trees (saponin) was also added.
Early trials had superior results in both monkey and human testing compared to larger companies. Conclusions from their phase one and two clinical trials state that the vaccine candidate appeared safe after 35 days and "elicited immune responses that exceeded levels in Covid-19 convalescent serum."
Could It Be the Best Vaccine?
Andrew Ward from Scripps Research and his team confirmed how good Novavax's vaccine candidate was in their recent study published in the journal Science. The researchers described the structure of the vaccine and "observed novel interactions between the spike trimers allowing [the] formation of higher-order spike complexes."
The nanoparticle formation of the vaccine, the study described, may result in a stronger immune response compared to vaccines made with soluble trimers alone. Ward's team saw how stable the vaccine structure is and the vigorous antibody response during early monkey and human trials.
Due to research for the coronavirus vaccine, the company gained nearly 300 new employees and will be expanding its Maryland campus for research and development (R&D), manufacturing, and office space. By 2021, they aim to produce Covid-19 vaccines for one billion people alongside their partner manufacturers.
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