Novavax (NVAX) CEO Stanley Erck expects the U.S. Food and Drug Administration (FDA) to consider using company data in the UK to accelerate the launch of its COVID-19 vaccine, rather than waiting until the end March.
The 89.3% effectiveness rate in the United Kingdom is a combined result of effectiveness against the original strain and that of the United Kingdom (B.1.1.7). The vaccine was 96% effective against the Wuhan strain and 86% effective against the UK strain, Erck told Yahoo Finance in an interview on Friday.
The company is confident of working through the regulatory process, but Erck said it is working with the FDA to try to obtain data from the United Kingdom to initiate the application for emergency use authorization (USA).
“You are preparing to close the trial in the United States in March and then analyze the data,” said Erck.
The company also obtained interesting results from its Phase 2b trial in South Africa, the source of the most worrying coronavirus strain (B.1.351). The company is working on creating an additional injection or reinforcement to protect against this tension, said Erck, noting that the effort to do so would not be so heavy.
“They are basically the same entity,” said Erck of the variants.
The company grew rapidly in the last year, preparing for its first vaccine on the market – a history it shares with Moderna (MRNA) – and investing heavily in manufacturing capacity through purchases and partnerships.
“A year ago, today we had zero and now, today, we bring together eight different large-scale commercial factories,” said Erck, noting that the factories are spread across the USA, Europe and Asia.
“I don’t think anyone has ever tried to put eight plants into operation at the same time for biological products; it’s unprecedented, but we did it, ”said Erck.
The capacity will be especially useful for rotating and producing additional doses to fight new strains.
“Instead of making a Wuhan batch, we can make a variant batch from the UK or a variant batch from South Africa, we can change very quickly,” said Erck.
The company is still in Phase 3 testing in the United States, after a brief delay that postponed the start of the final phase to December.
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