Specifically, the European Medicines Agency is looking at Gaithersburg, Md.-based Novavax’ application for conditional marketing authorization for Nuvaxovid.
The stock on Wednesday traded at $186.72, up 9.5% at last check. It has soared 70% year to date amid investor enthusiasm for the vaccine.
"Today's announcement from EMA brings Novavax another step closer to our goal of ensuring broad global access to our protein-based Covid-19 vaccine across Europe," said Novavax Chief Executive Stanley Erck.
The EMA has indicated that its assessment will proceed under an accelerated timeline, with an opinion issued potentially within weeks, Novavax said.
“The chemistry, manufacturing and controls data package submitted to EMA and other global regulatory agencies leverages Novavax' manufacturing partnership with the Serum Institute of India, the world's largest vaccine manufacturer by volume,” Novavax said.
“It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.”
The Novavax/SII vaccine recently received emergency use authorization in Indonesia and the Philippines. Novavax also has filed for approval with the World Health Organization, India, the U.K., Australia, New Zealand and Canada.
“Novavax expects to submit the complete package to the U.S. FDA [Food and Drug Administration] by the end of the year,” the company said.
The vaccine “is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated … 89.7% efficacy overall and the PREVENT-19 trial in the U.S. and Mexico that demonstrated … 90.4% efficacy overall.”