FDA Fast-Tracks Novavax COVID-19 Vaccine NVXCoV2373

Novavax said Monday that its experimental COVID-19 vaccine NVX-CoV2373 has received fast-track designation from the FDA. The company also reiterated that it expects to begin a pivotal phase 3 trial of the candidate in the US and Mexico by the end of November, data from which could be used to support global marketing filings.

Gregory Glenn, who heads the company’s R&D operations, stated that “while the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy.”

In late October, Novavax indicated that the start of the US trial was pushed back by about a month due to delays in scaling up the manufacturing process, although it said it had made “significant progress” on that front. It had originally expected the 30,000-person trial to start enrolling in mid-October.

Meanwhile, Novavax’s ongoing phase 3 trial in the UK, which it recently expanded to 15,000 participants from an original size of 10,000, is also expected to be fully enrolled by the end of November. The company continues to expect that interim data from the study will be available as soon as the first quarter of 2021, depending on the overall COVID-19 attack rate.

Novavax is preparing to deliver 100 million doses of NVX-CoV2373 to the US, possibly as early as year-end, as part of a $1.6-billion contract there. The company has also signed supply agreements with the UK, Canada and Japan.

The latest news comes as Pfizer and BioNTech reported preliminary results Monday showing that their COVID-19 vaccine candidate BNT162b2 was 90% effective in a late-stage trial. The partners, which had received a fast-track designation from the FDA in July, could be the first to seek an emergency-use authorization in the US.