Novavax files for Covid-19 vaccine’s UK authorisation

Company to submit application for US authorisation by end of the year

Photograph: iStock

Photograph: iStock

 

Novavax said on Wednesday it had completed the real-time submission of an application for the authorisation 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 UK, showing that the experimental vaccine was 96.4 per cent 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 per cent protection against moderate and severe disease and 90.4 per cent effectiveness overall.

Novavax expects to submit the complete application seeking US authorisation 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 Organisation soon. – Reuters