By Robb M. Stewart
Novavax Inc. has applied for a conditional marketing authorization in the UK for its Covid-19 vaccine candidate with the completion of an ongoing submission to the UK Medicines and Products Regulatory Agency. health.
The submission is based on advanced data from around 45,000 patients who the company says have demonstrated high efficacy and well-tolerated safety, including against variants of Covid-19.
The filing markets the first protein-based Covid-19 vaccine submitted to the UK agency for authorization, and Novavax said submissions to other regulatory authorities, including the European Union, Canada and Australia, are expected soon.
In pre-market trading, shares of the biotech company were up 9.2% after closing the previous session at $ 134.99, up more than 20% from late last year.
“This submission brings Novavax significantly closer to delivering millions of doses of the first protein-based Covid-19 vaccine,” said Stanley Erck, chairman and CEO of the company, adding that the company will be ready to deliver vaccine doses. if it receives a positive decision.
Novavax said it has completed the submission of all modules required by the MHRA for regulatory review of NVX-CoV2373, the company’s recombinant nanoparticle-based Covid-19 vaccine with the adjuvant Matrix-M, including data preclinical, clinical and chemical, manufacturing and control. .
Clinical data from a Phase 3 trial of 15,000 UK volunteers was submitted to the MHRA earlier this year, in which NVX-CoV2373 was shown to be 96.4% effective against the virus strain of original, 86.3% versus the Alpha variant and 89.7% overall effectiveness, as well as a favorable safety and tolerability profile, Novavax said.
Write to Robb M. Stewart at [email protected]