NEW YORK, March 2 ― Novavax Inc's chief executive said yesterday its Covid-19 vaccine could be cleared for use in the United States as soon as May if US regulators authorise it based on data from the company's British trial, which could be completed as soon as April.
But he added that talks with the US Food and Drug Administration are ongoing and the FDA may require that Novavax submit data from its US trial, which could take an additional two months to read out and push back US clearance to mid-summer.
Novavax can already manufacture its shots at scale and will be able to have tens of millions of doses stockpiled and ready to ship in the United States when it receives authorisation, Chief Executive Stanley Erck said.
“It will be substantial ― in the many tens of millions or a hundred million,” Erck said in an interview.
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 shot would be the fourth to receive authorisation for use in the US Johnson & Johnson's vaccine was given clearance on Saturday. Pfizer Inc and Moderna Inc were authorised in December.
Novavax's shot is a two-dose regiment like Pfizer's and Moderna's but is easier to ship as it can be stored at referigerator temperatures, rather than in a freezer.
Novavax on Monday reported that its net loss widened to US$177.6 million (RM720.5 million), or $2.70 per share, in the fourth quarter, from US$31.8 million, or US$1.13 per share a year earlier.
Boosted by vaccine business, revenue rose to US$279.7 million from US$8.8 million a year earlier.
Novavax shares rose as much as 2.4 per cent after it announced earnings yesterday.
Novavax promised to deliver doses to the United States after it was awarded US$1.6 billion to help finance research, development and production of a Covid-19 vaccine.
An early data readout in January from its UK trial showed the vaccine to be around 96 per cent effective against the original version of the coronavirus and around 86 per cent effective against the now widely circulating variant first discovered in Britain.
Novavax completed enrollment of its 30,000-subject US-based trial in February. ― Reuters