Novavax to Begin Phase 3 Study of COVID-19 Vaccine in U.S. Next Month

Novavax has announced that it will start a late-stage clinical trial of its investigational COVID-19 vaccine in the U.S. by the end of November.

The phase 3 study, which is being funded under the federal government’s Operation Warp Speed initiative, calls for the enrollment of up to 30,000 participants in the U.S. and Mexico, with “proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age and those living with co-morbidities,” the company said.

To date, 5,500 volunteers have enrolled in a separate phase 3 clinical trial in the UK for the vaccine candidate, NVX-CoV2373. That study, which began Sept. 24, is evaluating the safety and efficacy of two doses of the vaccine vs. a placebo. It is now being expanded to enroll up to 15,000 adult participants by the end of November. Depending on the trial’s progress, the company expects interim data as soon as early in the first quarter of 2021.

Novavax said it will present new phase 2 data during an Oct. 30 public meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

The company also said it is making “significant progress” in large-scale manufacturing but with some delay from its original timeline. In August, the Maryland-based drugmaker chose India’s Serum Institute to commercialize NVX-2373 in low- and middle-income countries, as well as in India. Under the agreement, the Serum Institute will produce a minimum of 1 billion doses of the vaccine for these countries. In mid-September, the agreement was expanded to produce more than 2 billion doses of the vaccine annually (DID, Sept. 30). — Martin Berman-Gorvine