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Novavax Stock Jumps As Drugmaker Looks to FDA Filing For Covid Vaccine By Year End

Novavax filed for emergency use approval in the UAE Monday and said it would have a 'complete package' for the US FDA by the end of the year.

Novavax  (NVAX) - Get Novavax, Inc. Report shares jumped higher Monday after the drugmaker said it will file a package of data linked to its developing coronavirus vaccine with the U.S. Food & Drug Administration by the end of the year.

Novavax, which delayed its schedule for Emergency Use Authorization approval from the FDA earlier this year, also submitted a filing for similar permission in the United Arab Emirates Monday, following data from late-stage trials in the U.S, Mexico and the United Kingdom of its NVX-CoV2373 vaccine, now known as Nuvaxovid.

Efficacy rate for the vaccine reached close to 90% in the U.K. trial, Novavax, said, and 93.2% against "predominantly circulating variants of concern and variants of interest" in the U.S. and Mexico. The data were collected prior to the identification of the Omicron variant late last month.

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The European Medicines Agency is examining the Nuvaxovid trial data as part of an accelerated timeline under market authorization approval process, the company said last month, and expects a full decision in the coming weeks. 

"The rapid emergence and continued spread of variants is a stark reminder that no one is safe until everyone is safe in the fight against COVID-19," said VRO Stanley Erck. "We remain committed to delivering our vaccine, which is based on a proven, well understood platform, to countries around the world as we anticipate that ongoing vaccination will be necessary over the long term to end the pandemic."  

Novavax shares were marked 3% higher in early trading Monday to change hands at $172 each, although that move would still leave the stock with a six month decline of more than 15%.