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MARYLAND: Novavax’s COVID-19 vaccine could be licensed for use in the United States in May if US regulators authorize it based on data from the company’s British trial, which could be completed “in the next few weeks,” said its CEO on Monday (March 1).
However, CEO Stanley Erck added that talks with the US Food and Drug Administration are ongoing and that the agency may require Novavax to submit data from its US trial, which could take two. additional months to complete, delaying US clearance until mid-summer.
Novavax shares fell 5.6% to US $ 226.85 in extended trading after initially rising following the release of its quarterly results. The shares have soared about 2,400 percent from $ 9.82 on January 21, 2020, when the company announced it was developing a coronavirus vaccine.
Preliminary data from its UK trial published in January showed that the vaccine is around 96 per cent effective against the original version of the coronavirus and around 86 per cent against the now widely circulating variant that was discovered by first time in Britain.
Novavax can already manufacture its injections at scale and will be able to have tens of millions of doses in stock and ready to ship to the United States when it receives authorization, Erck said.
“It will be substantial, in the many tens of millions or a hundred million,” Erck said in an interview.
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Novavax had promised to deliver 110 million doses to the US government by the end of the third quarter. That could happen as early as July, Erck said.
Novavax’s vaccine production plants should be fully operational by April, Novavax research chief Gregory Glenn said in a conference call after the company reported quarterly results.
“In April, May and June, we should be finishing product filling and finishing prior to regulatory approvals,” Glenn said.
In late January, Erck said he expected Novavax to take several weeks to present UK test data to regulators in the UK, Europe and elsewhere. Novavax could produce up to 150 million doses per month in May or June, he added in an interview in January.
The Novavax injection, if authorized, would add to the vaccine options for millions of Americans awaiting immunization against the coronavirus.
Johnson & Johnson’s one-dose vaccine became the third to be cleared for emergency use by the United States on Saturday. Vaccines produced by Pfizer with its partner BioNTech and Moderna received USA in December.
Novavax’s vaccine is a two-dose regimen like Pfizer’s and Moderna’s, but it’s easier to ship as it can be stored at refrigerator temperature, rather than frozen.
Novavax promised to deliver doses to the United States after the Trump administration awarded it $ 1.6 billion to help fund research, development and production of a COVID-19 vaccine.
Novavax completed enrollment for its 30,000-subject trial in the US in February.
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