Novavax, swamped with FDA's manufacturing 'questions,' hopes for U.S. coronavirus shot trial within the year

With two players in the race for a COVID-19 vaccine nearing the finish line on world-first regulatory approvals, Maryland biotech Novavax continues to lag behind in getting its candidate into a late-stage trial in the U.S. Now, that trial has been pushed back further as the FDA targets its manufacturing plans.

The FDA has lobbed "additional questions" at Novavax's plan to lean on partner Fujifilm Diosynth Technologies' North Carolina plant for commercial-scale manufacturing of its vaccine for a phase 3 North American trial, the company said Monday. The added scrutiny has pushed the study's start date into late December at the earliest.

The FDA's line of questioning on the Fujifilm plant is unclear—a Novavax spokeswoman wouldn't clarify what the agency's questions were in an email—but the biotech is switching to a commercial-scale facility to power the study after using smaller, clinical-scale batches for earlier trials. Novavax previously forecast it would launch the U.S. trial by November.

"At this point, we have satisfied most of the FDA requirements and any questions that they had around the trial protocol and Phase 1/2 data," the spokeswoman said. "We are now submitting remaining data packages that we expect to clear the way for their final approval to begin the trial soon."

While its U.S. trial is delayed, the biotech has completed enrollment of its 15,000-patient U.K. phase 3 trial and is wrapping up a phase 2b study in South Africa, Novavax said Monday.

Like its peers in the hunt for a COVID-19 vaccine, Maryland's Novavax has scaled up its in-house production capacity for its recombinant DNA vaccine candidate and tapped outside manufacturing partners, including Fujifilm.

The company has also worked to flesh out its manufacturing brain trust in anticipation of growing to commercial scale. In June, Novavax appointed Ben Machielse as its executive vice president of chemistry, manufacturing and controls to help prep both its COVID-19 shot and its late-stage flu candidate for regulatory approval.

RELATED: Novavax expands in Maryland as it gears up for late-stage COVID vaccine trial in the U.S.

Earlier this month, Novavax entered a 15-year lease for about 122,000 square feet of offices on Quince Orchard Road in Gaithersburg, Maryland, for manufacturing, office space and R&D activities.

The drugmaker plans to have the site ready to use early next year. Novavax also purchased 9.7 acres on Firstfield Road in Gaithersburg for future development. State, local and county governments provided development incentives for the moves.

Prior to that, Novavax in May purchased Praha Vaccines and its vaccine factory in the Czech Republic—a buyout that could hold capacity for 1 billion doses per year. Novavax also enlisted Fujifilm in April to produce the vaccine at sites in North Carolina and Texas.

Given its big investments in manufacturing at scale, Novavax expected as recently as August to be able to churn out "billions" of doses of the vaccine, putting its potential output on par with leading drugmakers in the COVID-19 fight including Pfizer and AstraZeneca.

RELATED: Novavax aims for billions of COVID-19 vaccine doses in 2021—more than enough to supply U.S.

Any other delays in its late-stage trials would put Novavax even further on its back foot as other leaders in the hunt for a COVID-19 vaccine have already read out interim late-stage data and are chasing emergency use authorizations (EUAs).

Monday, Massachusetts biotech Moderna said it would file for an EUA after a confirmatory review showed its mRNA-based vaccine was 94.1% effective in preventing symptomatic COVID-19. Pfizer and partner BioNTech have already submitted for an EUA of their own after their candidate posted 90% efficacy in a late-stage interim readout.