Novavax COVID-19 Injection May Be Authorized For Use In US Starting May -CEO

March 1 (Reuters) – Novavax Inc chief executive said Monday that its 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 as soon as April.

Novavax can now manufacture its injections at scale and may have tens of millions of doses in stock and ready to ship to the United States when it receives authorization, 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.

The deadline for US authorization would be pushed back to June or July if regulators choose to wait for Novavax to complete its US trial before reviewing the vaccine, he said.

Novavax reported Monday that its net loss increased to $ 177.6 million, or $ 2.70 per share, in the fourth quarter, from $ 31.8 million, or $ 1.13 per share a year earlier.

Driven by the vaccine business, revenue increased to $ 279.7 million from $ 8.8 million a year earlier.

Novavax promised to deliver doses to the United States after it was awarded $ 1.6 billion to help fund the research, development and production of a COVID-19 vaccine.

An early reading of data in January from its UK trial showed the vaccine to be around 96% effective against the original version of the coronavirus and around 86% against the now widely circulating variant that was first discovered. time in Britain.

Novavax completed enrollment for its 30,000-subject trial in the US in February. (Reporting by Carl O’Donnell Edited by Bill Berkrot)


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