Novavax Files for COVID-19 Vaccine Authorization in UK

Novavax has submitted an authorization filing for its COVID-19 vaccine in the United Kingdom, the biotechnology company announced on Oct. 27.

Novavax said that it has completed its rolling regulatory submission to the UK Medicines and Healthcare products Regulatory Agency, marking its first COVID-19 vaccine authorization filing in the UK.

“This submission brings Novavax significantly closer to delivering millions of doses of the first protein-based COVID-19 vaccine,” Novavax President and Chief Executive Stanley Erck said, adding that they are anticipating “a positive decision.”

About 15,000 volunteers participated in the clinical trial in the UK.

Novavax said that its vaccine showed an efficacy of 96.4% against the original virus strain, 86.3% against the Alpha strain, and 89.7% overall.

Novavax expects to complete additional regulatory filings in other key global markets, including Europe, Canada, and the World Health Organization.

Novavax also expects to submit a complete package to the United States Food and Drug Administration by the end of 2021.

© Fourth Estate® — All Rights Reserved.
This material may not be published, broadcast, rewritten or redistributed.

Leave a Comment