- The U.S. government will fund late-stage testing and manufacturing of an experimental coronavirus vaccine being developed by Novavax, granting the Maryland-based drugmaker $1.6 billion in a collaboration announced Tuesday.
- Under the agreement, which was made by the Departments of Defense and Health and Human Services, Novavax will work to produce 100 million doses of its experimental shot in parallel with clinical testing. The resulting supply would be owned by the U.S. government, which would be responsible for distribution if studies prove the vaccine safe and effective.
- Novavax's vaccine is currently being tested in some 130 healthy volunteers in Australia. Initial safety and immune response results are expected this month and, should they look positive, the study would be expanded further. A Phase 3 trial, which would likely involve 30,000 people, is currently scheduled to begin this fall.
Novavax is the latest company to receive federal support through an aggressive plan by the Trump administration to ready hundreds of millions of vaccine doses for use beginning as soon as the end of this year, or early next.
The $1.6 billion agreement is the richest to date, topping the $1.2 billion the U.S. government said it would pay to secure 300 million doses of another vaccine being developed by the University of Oxford and AstraZeneca.
All told, the U.S. government has put roughly $4 billion toward vaccine development and manufacturing, including large grants to Moderna and Johnson & Johnson.
The investments are designed to fund the kind of large-scale studies needed to prove a vaccine safe and effective, as well as to begin manufacturing doses even before those studies deliver results.
Moderna and Pfizer, the latter of which while part of the U.S. government's plans isn't accepting any external funding, both expect to this month begin Phase 3 trials enrolling 30,000 Americans each. A similarly sized trial of AstraZeneca's candidate is set to begin in August, The Wall Street Journal reported, and one testing J&J's shot could follow by September.
Novavax is now in the mix as well, with the money from the U.S. government supporting a Phase 3 trial that could begin this fall. The company was already working with the Defense Department, having signed a $70 million deal for 10 million doses in June. That supply could be used in either the Phase 3 testing or for potential emergency use, if the Food and Drug Administration authorized Novavax's shot.
Novavax's candidate, which relies on coronavirus-derived proteins to stimulate an immune response, is given via two injections, spaced three weeks apart. The 100 million doses the U.S. is buying, therefore, could in theory vaccinate 50 million people.
In addition to the U.S.' support, Novavax is backed by the Coalition for Epidemic Preparedness Innovations, which gave the biotech a $388 million grant in May.
Founded in 1987, Novavax has a long track record but has yet to deliver an approved vaccine, although positive study results in March for an influenza vaccine could put the company in striking distance.
Shares in Novavax rose by nearly a third in Tuesday morning trading on news of the U.S. government's purchase order.