Some Americans could receive COVID-19 vaccinations before the end of 2020. Two coronavirus vaccines are in a prime position to win U.S. emergency use authorization (EUA) next month -- Pfizer's (PFE) and BioNTech's (BNTX -0.91%) BNT162b2 and Moderna's (MRNA 0.63%) mRNA-1273.
Novavax (NVAX -4.10%) lags behind with its experimental coronavirus vaccine candidate NVX-CoV2373. The company expects to report results from a late-stage study conducted in the U.K. in early 2021 with results from its planned U.S. late-stage study likely coming a couple of months later.
The old adage that "the early bird gets the worm" is often true. First-movers frequently achieve the greatest success. In this case, though, there's a realistic chance that Novavax will be a bigger COVID vaccine winner than Pfizer or Moderna over the long run.
Hurdles to jump
Novavax definitely must first jump multiple hurdles to overtake Pfizer and Moderna. Perhaps the greatest challenge is that both companies have already reported fantastic interim efficacy results for their respective coronavirus vaccine candidates. Moderna wowed observers earlier this month by reporting efficacy for mRNA-1273 of 94.5%. Pfizer, which had reported efficacy of 90% or greater for BNT162b2 a week earlier, promptly followed up with more data showing efficacy of 95% for its vaccine.
It remains to be seen if NVX-CoV2373 can achieve an efficacy level close to 95%. However, Novavax's early stage results were so good that multiple analysts referred to its COVID vaccine as potentially best in class. The additional boost that the biotech's Matrix-M adjuvant provides could make a key difference in how effective NVX-CoV2373 is.
Of course, Novavax's coronavirus vaccine must also demonstrate a good safety profile. Based on the results announced so far, that shouldn't be a problem. However, there's certainly a possibility that late-stage testing could uncover a potential issue.
One hurdle that won't be too big for Novavax, though, is lining up supply deals for NVX-CoV2373. The company secured agreements with the U.S., Canada, U.K., and Australia to supply a total of at least 276 million doses.
A two-for-one option
Novavax could very well hold its own against Pfizer and Moderna if NVX-CoV2373 delivers on its potential. But there's another option that just might make the company a much bigger winner than either of these rivals over the long run.
In October, Novavax announced that it had formed a team to focus on winning regulatory approvals in key global markets for flu vaccine candidate NanoFlu. The biotech also stated that this team will explore the potential for pairing NanoFlu with NVX-CoV2373 in a combination flu/COVID-19 vaccine.
Neither Pfizer nor Moderna have seasonal flu vaccines in clinical development right now. Pfizer is collaborating with BioNTech on a flu vaccine candidate, but it's still in preclinical trials. Moderna has indicated that it plans to develop a messenger RNA (mRNA) flu vaccine. Again, though, the biotech hasn't advanced any candidate into clinical testing.
That puts Novavax potentially in the driver's seat for a combo flu/COVID-19 vaccine. The company has a flu vaccine and a COVID vaccine that could be on track to win regulatory approvals. Novavax just might be the first to launch a combo vaccine after the pandemic ends. Assuming that the novel coronavirus that causes COVID-19 becomes a seasonal virus like the flu, it wouldn't be shocking for Novavax to achieve greater market success than Pfizer or Moderna (at least for a while).
There's also another way that Novavax could be a bigger COVID vaccine winner than Pfizer or Moderna. Actually, the biotech is already a bigger winner on this front. I'm referring to stock performance.
Novavax's share price has skyrocketed over 3,000% so far this year. Pfizer and Moderna don't come close to delivering such a tremendous gain.
If NVX-CoV2373 achieves a high efficacy level and a solid safety profile in late-stage testing, Novavax will without question move much higher. The biotech stock has an even greater opportunity if Novavax successfully advances a combo flu/COVID-19 vaccine.
The coronavirus vaccine market probably won't have a winner-takes-all company. However, some vaccine makers could be bigger winners than others. And Novavax appears to have a pretty good shot at being one of those biggest winners.