Novavax Delays COVID-19 Vaccine Production Timeline, Sees Filing for Authorization in 3rd Qtr

By Trisha Roy and Carl O'Donnell

May 11, 2021

(Reuters) - Novavax Inc said on Monday production of its COVID-19 vaccine will ramp up at a slower pace than it had previously anticipated and it does not expect to file for regulatory authorization in the United States, Britain or Europe until the third quarter of 2021.

Novavax said it does not expect to hit its production target of 150 million shots per month until the fourth quarter of 2021, later than its previous goal of the third quarter. It had also previously said it could be authorized in the United States as early as May.

The U.S. company has repeatedly pushed back its production timeline and has said it is struggling to access raw materials and equipment needed to manufacture its vaccine. Shares fell 3% in after hours trading after closing nearly 9% lower on Monday.

Novavax's shot has yet to be authorized by regulators in any country, but it has reported late-stage data from a UK trial that shows it to be highly effective against the original version of the coronavirus and a newer, more contagious variant first found in Britain.

Data from its pivotal U.S. and Mexico trial is expected to be released in the current quarter.

While vaccine demand is declining in the United States, the Novavax shot is expected to play an important role in global inoculation efforts, with many countries such as India and much of South America desperate for supplies.

"Unmet demand outside of the United States has resulted in continued demand for Novavax's vaccine," said Chief Commercial Officer John Trizzino.

The company has committed to supply 200 million shots to countries around the globe, in addition to the 1.1 billion doses it has committed to the COVAX international vaccine sharing program, Trizzino said.

Novavax reported a net loss for the first quarter of $223 million. It had $447 million in revenue, mostly payments from the U.S. government for its COVID-19 vaccine research, and spent $593 million on research and development.

Open https://tmsnrt.rs/3c7R3Bl in an external browser for a Reuters graphic on vaccines in development.

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