Novavax Inc. shares were up 6.5% to $181.54 after the company updated on the regulatory progress of its Covid-19 vaccine in Europe.
The biotechnology company said the European Medicines Agency has begun its evaluation of an application for conditional marketing authorization for its Covid-19 vaccine, which would be marketed in the European Union under the brand name Nuvaxovid.
The company said earlier this month it had completed the submission of all data and modules required by EMA for regulatory evaluation of NVX-CoV2373, Novavax's Covid-19 vaccine. The EMA indicated its assessment will proceed under an accelerated timeline, with an opinion issued potentially within weeks, the company said.
Novavax said it expects to submit the complete package to the U.S. Food and Drug Administration by the end of the year.
Also Wednesday, Novavax and vaccine manufacturer Serum Institute of India Pvt. Ltd. said the Philippine Food and Drug Administration granted emergency use authorization for Novavax's Covid-19 vaccine.
The vaccine will be manufactured and marketed in the Philippines by SII under the brand name Covovax.
Because the vaccine is stored with standard refrigeration, it may be transported and stored using the existing vaccine supply chain, potentially increasing access in hard-to-reach areas, the companies said.
"With less than a third of the Philippine population fully immunized, we expect the option for a protein vaccine, built on a well-understood technology platform, to contribute substantially to increased vaccination rates," said Novavax Chief Executive Stanley C. Erck.
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