The FDA is no longer Novavax's first choice. The Maryland biotech has instead completed submission of its protein-based COVID-19 vaccine to the U.K.'s regulator and will wait a bit longer before asking the FDA for clearance.
Novavax has finalized and submitted all documents to the Medicines and Healthcare products Regulatory Agency, or MHRA, for conditional marketing authorization of the jab, the company said Wednesday.
About 45.5 million people, or nearly 68% of the population in the U.K. have gotten two doses of a COVID-19 vaccine already.
Shares of Novavax rose about 10% to $148.20 as of 9:51 a.m. ET.
As for the U.S. submission, Novavax is slated to complete a request to the FDA by the end of 2021. May was the original target, then July and then sometime later in the year. Now, the company thinks the application will be in before the clock hits 2022.
The biotech has received about $1.74 billion in support from the U.S. government for its COVID-19 vaccine work. The Trump administration signed on to buy 110 million doses of the shot, just as it did for other potential vaccines in the early stages of development. Across the pond, the European Commission has purchased 100 million doses and secured the option for another 100 million in 2023.
Additional requests are to come in the European Union, Canada, Australia and New Zealand. The European Medicines Agency filing was expected to be completed in the third quarter, the company said earlier this year, and requests in those other regions were expected "within weeks" of the U.K. one, Novavax said in an SEC filing in August.
Through manufacturing partners in India, South Korea, Japan and its own site in the Czech Republic, Novavax can handle the production of 150 million doses per month by the end of this year, the company said last week.
The request for a go-ahead is based on data from approximately 45,000 patients.
That includes 15,000 people from a phase 3 U.K. trial that showed the vaccine, dubbed NVX-CoV2373, had 96.4% efficacy against the original strain of SARS-CoV-2, 86.3% against the Alpha variant and 89.7% overall. Novavax also sent in data from a trial of about 30,000 people in the U.S. and Mexico which showed 100% protection against moderate and severe disease and 90.4% efficacy overall.
Novavax and partner the Serum Institute of India have already filed the jab for authorization in India, Indonesia and the Philippines, and have requested an emergency use listing with the World Health Organization. Through the WHO arrangement, Novavax and SII are expected to deliver 1.1 billion doses.