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.
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%.