(Bloomberg) --
Novavax Inc. applied for authorization of its Covid-19 vaccine in the U.K., the first submission for a protein-based shot against the disease in the region.
The company has completed its rolling submission -- an accelerated review of trial and manufacturing data -- with the Medicines and Healthcare products Regulatory Agency and filed for a conditional marketing license, Gaithersburg, Maryland-based Novavax said in a statement Wednesday. The shares rose 13% in U.S. premarket trading.
Novavax submitted clinical data to the regulator from an advanced-stage trial of 15,000 volunteers in the U.K. earlier this year. The shot demonstrated efficacy of 96.4% against the original Covid strain and 86.3% against the alpha variant that first arose in the U.K. The company also has data from a 30,000-person trial in the U.S. and Mexico, which demonstrated 100% protection against moderate and severe disease.
The drugmaker is planning to apply for authorization in the U.S. by year-end, according to the statement. An application for emergency authorization from the World Health Organization was made last month. The vaccine requires two doses three weeks apart and can be stored at refrigerator temperatures, making it easier to transport than some messenger RNA shots.
Novavax’s vaccine mimics the coronavirus’s spike protein, sparking an immune response that prepares the body for a real infection.
©2021 Bloomberg L.P.
Advertisement