- Novavax has started a study of its experimental coronavirus vaccine that will enroll 10,000 adult volunteers in the U.K., the first of multiple planned large-scale efficacy trials for its shot.
- The trial, which begins as COVID-19 cases in the country surge, will test a two-dose regimen with shots spaced three weeks apart. With the help of the U.K. government, the biotech expects to complete enrollment over the next four to six weeks, and is also planning an additional, larger Phase 3 study in the U.S. that should start next month and a third trial in India.
- Novavax is the latest vaccine developer to begin late-stage testing of a coronavirus vaccine, following companies like Moderna, Pfizer, AstraZeneca and, earlier this week, Johnson & Johnson. But the biotech is the first to get there with a protein-based vaccine, a more established type of inoculation than others are developing.
Novavax has a lower profile than several of the other companies leading the global race to develop a coronavirus shot. The Maryland-based drugmaker spent nearly three decades working to break into the vaccine business, and is only now on the cusp of having an approved product, a flu shot that's close to regulatory review.
But, during the pandemic, Novavax has kept pace with larger and more experienced drugmakers, narrowly trailing the pace set by Pfizer, AstraZeneca and J&J. The company has signed key deals with the U.S. government and others that have given it the outside funding and manufacturing capacity needed to move quickly.
Early study results, published this month, suggest a two-dose regimen of Novavax's shot can trigger a potentially meaningful immune response and may also be "the most tolerable ... compared to other leading vaccine candidates," analysts at SVB Leerink recently wrote.
Novavax's protein-based approach may also be an important advantage. The company used coronavirus-derived proteins, along with an immune-boosting adjuvant, to train the body against SARS-CoV-2 infection. Moderna, Pfizer and AstraZeneca, the three frontrunners in the U.S. and Europe, are each using newer technologies that rely on snippets of genetic code.
Shares in Novavax have climbed nearly 11-fold since February, when COVID-19 cases began to climb throughout the U.S. The company has more than doubled the size of its workforce since April and plans to add another 200 more employees in the U.S. in the coming months, CEO Stanley Erck said Thursday.
"That will bring us from 165 people globally to around 1,000 people globally to be able to produce a vaccine," he said.
As with the other experimental vaccines, it's still unclear whether Novavax's shot can prevent coronavirus infection or COVID-19. To get answers quickly, vaccine makers are trying to run their large-scale efficacy trials in areas with many newly occurring cases — a challenge as disease outbreaks can come and go in different areas. China-based developers like CanSino Biologics, for instance, have had to go to regions where cases are still climbing to conduct their tests.
The U.S. has been one such hotspot, with four companies starting trials set to enroll more than 120,000 people combined. But the U.K., where Novavax has begun its first Phase 3 trial, is now another, following a worrisome resurgence in infections that has led Prime Minister Boris Johnson to tighten restrictions and call for citizens to work from home.
Though it's likely not to be the largest trial of Novavax's vaccine, the study could provide important answers. Novavax, for instance, plans to prioritize groups such as racial and ethnic minorities that are most affected by COVID-19. The company also wants elderly subjects, who are particularly vulnerable to the disease, to account for a quarter of its trial participants. Unlike some of its rivals, Novavax doesn't yet have data showing how well its shot works, and how safe it is, in the elderly.
Additionally, Novavax is testing a licensed flu vaccine alongside its experimental shot in a 400-patient sub-study, implying the possibility of a seasonal regimen should the coronavirus become endemic.
The study's two main goals are to prevent, in people who haven't previously been infected, the occurrence of either symptomatic, or moderate-to-severe COVID-19 at least seven days after the second shot. Other Phase 3 trials have included mild cases.
Novavax will do one interim check of the data after 67% of the cases it expects to need for a primary analysis occur. The company is using the lower dose of the two it has tested so far.