(Reuters) – Novavax Inc said on Wednesday it had completed the real-time submission of an application for the authorization of its COVID-19 vaccine candidate in the United Kingdom.
The submission is based on data from a late-stage trial in 15,000 volunteers in the United Kingdom, showing that the experimental vaccine was 96.4% effective against the original coronavirus strain.
The application also includes data from a 30,000-person late-stage trial in the United States and Mexico, showing that the vaccine, NVX-CoV2373, demonstrated 100% protection against moderate and severe disease and 90.4% effectiveness overall.
Novavax expects to submit the complete application seeking U.S. authorization by the end of the year.
The vaccine developer said it also expects to complete additional regulatory filings in markets including Europe, Canada, Australia, New Zealand and to the World Health Organization soon.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Vinay Dwivedi)
