Novavax Finishes Enrollment for U.S. Phase 3 COVID-19 Vaccine Trial

Novavax has announced that it has completed enrolling 30,000 participants in its late-stage U.S./Mexico pivotal trial of its COVID-19 vaccine, bringing its recombinant protein-based vaccine hopeful one step closer to potential FDA authorization.

The company previously unveiled positive interim efficacy results for the vaccine candidate, NVX-CoV2373, from its ongoing phase 3 UK trial, demonstrating that the two-dose vaccine demonstrated 89.3 percent overall efficacy against both the SARS-CoV-2 virus and the UK strain.

The European Medicines Agency (EMA) is currently conducting a rolling review of the vaccine’s nonclinical data and early clinical studies. The FDA is also evaluating that data. While it’s been anticipated that the company will not file for Emergency Use Authorization (EUA) until its U.S. trial data are ready for submission, a Novavax spokesperson told FDAnews Monday that it “expect[s] that we could be in a position to file for EUA” in early to mid-second quarter using the data from the UK trial.

“The timing depends on a number of factors, including the prevalence of disease, the enrollment speed and other epidemiological trends. That said, we expect to have initial results [from the U.S. trial] during [the second quarter],” the spokesperson said.

Novavax CEO Stanley Erck has previously said that patients would be observed for around six weeks after enrollment was completed before reviewing the data. Erck added that the company is already gearing up to bolster manufacturing capacity to the max, estimating that it could produce 150 million doses per month globally by May or June.

In addition to the ongoing phase 3 UK and U.S./Mexico trials, the company is also evaluating the vaccine in a phase 2b trial in South Africa and a phase 1/2 continuation trial in the U.S. and Australia. According to the company, the South African trial found the vaccine showed 50 percent to 60 percent efficacy against newly emerging variants.

The company has big plans to manufacture hefty amounts of the vaccine, recently announcing it had reached an agreement with Gavi, the Vaccine Alliance, to provide 1.1 billion doses for the COVAX project. The doses will be produced and distributed globally by Novavax and the Serum Institute of India. An advance purchase agreement between the company and Gavi is still being worked out. Currently, Novavax has a $1.6 billion deal with the U.S. government to supply 100 million doses (DID, Nov. 13, 2020).

Recently, the European Union announced that it is contributing an additional $607.9 million toward the COVAX program, doubling its previously pledged amount. The program aims to deliver at least 1.3 billion vaccine doses to 92 low- and middle-income nations by the end of the year. — James Miessler