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Regulators could authorize Novavax’s coronavirus vaccine as early as May, its CEO Stanley Erck predicted.
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This depended on whether the FDA would authorize the COVID-19 vaccine largely based on UK trial data, Erck said.
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Phase-three trials in the UK suggest the vaccine is highly effective, though slightly less so against variants.
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Novavax CEO Stanley Erck has predicted the company’s coronavirus vaccine could be authorized in the US as early as May.
Trial results suggest the vaccine is highly effective, though less so against the variant first found in South Africa, which has spread to at least 10 US states including New York.
The American biotech company has agreed to supply 110 million doses of its vaccine to the US, Erck told CNBC Monday, adding that he expected them to be delivered by June or July. But this depended on whether the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the vaccine largely based on trial data from the UK, Erck said.
Novavax is running three efficacy trials at same time, in the UK, South Africa, and US, Erck said. Data from the US phase-three trial, which has 30,000 participants, won’t come out for “probably a couple of months,” he said.
In the UK, Novavax already has phase-three trial data on the vaccine’s efficacy, suggesting that the shot is on average 89.3% effective at protecting against COVID-19.
The UK trial of 15,000 participants showed that the vaccine was slightly less effective on the B.1.1.7 strain, first identified in the UK and now spreading rapidly in the US. Novavax said roughly half of the participants who caught the coronavirus during the trial were infected with this variant, and the vaccine was 85.6% effective on them, compared to 95.6% on the original strain of the virus.
“It did show there’s a decrement as the virus mutates,” Erck told CNBC.
In a trial in South Africa, interim results show the vaccine was far less effective against the B.1.351 strain first found there.
Erck said Novavax would probably file for approval in the UK first, in about April, before submitting data to the FDA around a month later.
“Our hope and expectation is that the FDA will agree to review the [UK] data as part of our EUA filing in the US,” he said.
FDA regulators have so far given EUA to three coronavirus vaccines in the US, developed by Johnson & Johnson, Moderna, and Pfizer and BioNTech.
“I’m not worried about lack of demand for the vaccine even though we’ll be the fourth vaccine,” Erck told CNBC. “There’s plenty of additional need for the vaccine in the US, and it’s a big world.”
The company is also looking at filing for EUA in Canada and Australia, he said. Novavax currently has advance-purchase commitments to ship 200 million doses outside of the US “with the expectation that there’ll be a lot more on top of that,” he said.
In February, Novavax also said it would supply more than 1.1 billion doses of its vaccine to COVAX, a global World Health Organization-backed initiative to guarantee fair and equitable vaccine distribution.
Novavax has said that it is aiming to be able to make shots at a rate of 2 billion doses per year by the middle of 2021, though it’s not clear how many shots the company could actually make this year.
In comparison to Moderna and Pfizer-BioNTech’s vaccines, Novavax’s shot can be stored at normal fridge temperatures rather than freezing temperatures, Erck told CNBC. But people should get whichever vaccine is available to them, he said.
“All these vaccines work, and if they’re available people should take them,” he said.
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