UK data should be used to speed up deployment of US COVID-19 vaccine

Novavax (NVAX) CEO Stanley Erck is hopeful that the US Food and Drug Administration (FDA) will consider using the company’s UK data to speed up the rollout of its COVID-19 vaccine, rather than wait until later in March.

The efficacy rate of 89.3% in the UK is a combined result of efficacy against the original strain and the UK strain (B.1.1.7). The vaccine was 96% effective against the Wuhan strain and 86% effective against the British strain, Erck told Yahoo Finance in an interview Friday.

The company has confidence in the regulatory process, but Erck said he’s working with the FDA to try to get the UK data to start filing for an Emergency Use Authorization (EUA).

“You plan to leave in March to close the US lawsuit and then analyze the data,” Erck said.

The company also got some interesting results from its phase 2b trial in South Africa, the source of the coronavirus strain of most concern (B.1.351). The company is working on creating an extra hit or booster to protect against this strain, Erck said, noting that the effort to do so would not be as heavy.

“They’re basically the same entity,” Erck said of the variants.

The company has grown rapidly over the past year, preparing for its first vaccine on the market – a story it shares with Moderna (MRNA) – and is investing heavily in manufacturing capacity through procurement and partnerships.

“A year ago today we didn’t have one, and now, today, we have assembled eight large-scale commercial factories,” Erck said, noting that the factories are spread across the United States, in Europe and Asia.

“I don’t think anyone has ever tried to get eight factories up and running at the same time for organic products; it’s unprecedented, but we did it, ”Erck said.

The ability will be particularly useful for pivoting and producing extra doses to combat new strains.

“Instead of doing a batch of Wuhan, we can make a batch of British variants or a batch of South African variants, we can change very quickly,” Erck said.

The story continues

The company is still in Phase 3 in the United States, after a brief delay that pushed the start of the Endgame to December.

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