Novavax (NVAX) CEO Stanley Erck is hoping the U.S. Food and Drug Administration (FDA) will consider using the company’s U.K. data to speed up rollout of its COVID-19 vaccine, rather than waiting until later in March.
The 89.3% efficacy rate in the U.K. is a blended result of efficacy against the original and the U.K. strain (B.1.1.7). The vaccine was 96% efficacious against the Wuhan strain and 86% efficacious against the U.K. strain, Erck told Yahoo Finance in an interview Friday.
The company has confidence in working through the regulatory process, but Erck said he is working with the FDA to try get the U.K. data to start filing for an emergency use authorization (EUA).
“You’re looking at way off in March to get the U.S. trial closed and then analyze the data,” Erck said.
The company also had interesting results from its Phase 2b trial in South Africa, the source of the most concerning coronavirus strain (B.1.351). The company is working on creating either an additional shot or a booster to protect against this strain, Erck said, noting the effort to do so would not be as heavy a lift.
“They are basically the same entity,” Erck said of the variants.
The company has scaled up quickly in the past one year, readying itself for its first vaccine on the market — a story it shares with Moderna (MRNA) — and investing heavily in manufacturing capacity through purchases and partnerships.
“One year ago today we had zero, and now, today, we’ve put together eight different large-scale commercial plants,” Erck said, noting the plants are spread around the U.S., Europe and Asia.
“I don’t think anyone has ever tried to get eight plants up and running at the same time for biologics; it’s unprecedented, but we did it,” Erck said.
The capacity will be especially helpful to pivot and produce additional doses to fight the new strains.
“Instead of making a Wuhan batch, we can make a U.K. variant batch or a South African variant batch, we very quickly can switch,” Erck said.
The company is still in Phase 3 trials in the U.S., after a brief delay that pushed the start of the final phase to December.
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