Novavax Inc said on Monday it had filed for a US approval for the emergency use of its COVID-19 vaccine in adults, a much-awaited step for the company following months of struggles with development and manufacturing problems.
The filing is based on data provided to the US Food and Drug Administration last month and results of two late-stage trials in the United States, Mexico and the UK that showed the protein-based vaccine had an overall efficacy of about 90%, the company said.
The US submission follows authorizations for its vaccine from the European Medicines Agency and the World Health Organization, clearing the way for its use in Europe as well as low- and middle-income countries.