Novavax delayed the start of a large phase 3 trial for its COVID-19 vaccine in the U.S. and Mexico, thanks to delays in scaling up vaccine manufacturing. It aims to kick off the study at the end of November.
The news comes as the company ramps up a separate phase 3 study for the vaccine in the U.K., which has expanded to 15,000 patients from its original goal of 10,000, Novavax said in a statement Tuesday. More than 5,500 have enrolled so far, and Novavax expects to report data from the U.K. trial as soon as the first quarter of 2021.
The company will also present data from the phase 1/2 study of the candidate, NVX-CoV2373, on Friday at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
The phase 1/2 trial tested four dose regimens of the vaccine, adjuvanted and unadjuvanted, in healthy adults up to 59 years old. Early results reported in August showed that two dose levels of the vaccine triggered an immune response similar to those seen in patients who had recovered from the disease. At the time, the data had not yet been peer reviewed.
Novavax’s candidate uses nanoparticle technology to create an antigen from the coronavirus spike protein, along with the company’s Matrix-M adjuvant to boost patients’ immune response. Although the Maryland-based biotech was initially left off the list of U.S. governments finalists for Operation Warp Speed, it later scored a $1.6 billion deal with the initiative—the project’s largest funding commitment at the time.
Novavax has never brought a product to market, but it’s also developing a flu vaccine candidate that is nearing an FDA submission. It’s using the Operation Warp Speed funding to push its COVID-19 vaccine through late-stage development. It hopes to enroll 30,000 patients in the U.S. phase 3 program.
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With drug and vaccine makers working at breakneck speeds, Novavax isn’t the only company facing delays. Moderna delayed the phase 3 study of its mRNA vaccine this summer, while Johnson & Johnson and AstraZeneca both put their vaccine trials on hold in the following months. Both J&J and AstraZeneca’s studies are back on track.