Stanley Erck, CEO of Novavax (NVAX), hopes the US Food and Drug Administration (FDA) will consider using the company’s UK data to accelerate the COVID-19 vaccine, rather than until later in March to wait.
The efficiency rate of 89.3% in the UK is a mixed result of efficiency against the original and the British strain (B.1.1.7). The vaccine was 96% effective against the Wuhan tribe and 86% effective against the British tribe, Erck said in an interview with Yahoo Finance on Friday.
The company has confidence in working through the regulatory process, but Erck said he was working with the FDA to get the UK data to submit an emergency use authorization (EUA).
“You look in March to close the U.S. trial and then analyze the data,” Erck said.
The company also obtained interesting results from its phase 2b trial in South Africa, the source of the coronavirus strain with the greatest interest (B.1.351). The company is working to create an extra shot or amplifier to protect against this voltage, Erck said, trying to do so would not be such a heavy lift.
“They’re basically the same entity,” Erck said of the variants.
The company has grown rapidly over the past year and is preparing for its first vaccine on the market – a story it shares with Moderna (MRNA) – and through investments and partnerships is investing heavily in manufacturing capacity.
“Today we had a zero, and now, today, we have put together eight different large-scale commercial plants,” Erck said. He noted that the plants are distributed in the USA, Europe and Asia.
‘I think no one has ever tried to get eight plants going at once for biological agents; it is unprecedented, but we did it, ”Erck said.
The capacity will be especially useful to turn and produce additional doses to combat the new strains.
“Instead of making a Wuhan bundle, we can make a British variant or a South African variety, but we can switch very quickly,” Erck said.
The company is still conducting Phase 3 trials in the US, after a brief delay that pushed the start of the final phase to December.
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