Novavax (NVAX 2.08%) has climbed the most of any other healthcare company so far this year. Shares have soared more than 2,160% as the clinical stage biotech business has advanced its coronavirus vaccine candidate through trials and won a whopping $1.6 billion from the U.S. government to support its program.
The U.S. government has played a major role in the coronavirus vaccine race so far. Through Operation Warp Speed (OWS), the government has offered vaccine developers billions of dollars in an effort to bring a vaccine to market by January. Now, word on the street is that a launch may come even sooner. The Centers for Disease Control and Prevention (CDC) recently advised states to prepare for a possible vaccine rollout as soon as late October, according to news reports. That means a vaccine would be available before the presidential election on Nov. 3. Considering the timeline, let's take a look at whether it's a good idea to buy shares of Novavax before that day comes.
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Presenting early data
Does Novavax stand a chance at being first to market with its potential coronavirus vaccine? It's unlikely, but not impossible. Novavax's vaccine candidate is in phase 2 of clinical trials -- but eight rival companies have already started phase 3 studies. If these players stumble in late-stage trials, however, Novavax could cross the finish line first. It's not uncommon for developers to hit pause late in the game -- take AstraZeneca (AZN +0.00%), which has temporarily halted its phase 3 study after observing a suspected adverse reaction in an inoculated participant.
As long as Novavax sticks to its plan, which is to use the same schedule for its phase 2 study as it implemented for it phase 1 study, it is possible that the company could present phase 2 data to regulators earlier than expected. On Aug. 24, Novavax announced that it had enrolled the first volunteers in its phase 2 trial. The two-dose schedule consists of treatments that are administered 21 days apart. In phase 1, researchers performed the primary safety and immune response analysis on day 35 of the study. If enough participants sign up early in the phase 2 trial and the company sticks to its schedule, Novavax may generate some results by late September or early October.
Usually, the U.S. Food and Drug Administration (FDA) requires extensive phase 3 data to approve a vaccine. In light of the current health crisis, it's possible the agency will grant an emergency use authorization (EUA) to a vaccine prior to the availability of phase 3 results. In a Financial Times interview, FDA Commissioner Stephen Hahn said that the agency would consider earlier data as the basis for an EUA. An EUA does not constitute full approval, but would allow the product to be circulated during the crisis while clinical studies continue.
As for trial data, Novavax hasn't yet reported vaccine performance in older volunteers. That information is expected in phase 2 reports. But phase 1, which studied adults aged 18 through 59, showed positive results. Novavax said that 100% of trial participants produced neutralizing antibody activity greater than that which was found in recovered coronavirus patients. Neutralizing antibodies are important components of immunity, which defend cells against pathogens and infectious particles by disabling or "neutralizing" their adverse biological effects.
A timeline perspective
From a timeline and progress perspective, Novavax isn't a frontrunner. But the company still could be a winner even if it doesn't cross the finish line first. That's because one healthcare company probably won't be able to provide enough vaccines to meet global demand.
It's likely that regulators will approve more than one vaccine candidate if trial results are strong and companies can follow through with manufacturing and delivery. And in that case, Novavax is still on a great path. Novavax has secured a total of $2 billion in funding from OWS, the U.S. Department of Defense (DoD), and the Coalition for Epidemic Preparedness Innovations (CEPI) for its program. The company has also expanded its manufacturing capacity to provide at least 1 billion doses next year.
While we've seen how much the Trump administration has paid in its early vaccine orders, it isn't totally clear how much a Biden administration is willing to pay for doses. It is clear, however, that nationwide vaccination is a priority for the Democratic challenger. Biden has pledged to invest $25 billion in a manufacturing and distribution plan to make a vaccine accessible to all. If Novavax continues on its current path, it could earn even more government attention and funding after Nov. 3 -- no matter who wins the election.
Is Novavax a buy?
In recent weeks, Novavax has given back some of its share gains as rivals began later-stage trials. The market sell-off this week pared gains even further. Novavax stock is now down 50% from a high reached in August. Even though this looks tempting, cautious investors should refrain from buying. While Novavax's vaccine candidate may be successful, failure is still a possibility. And the company's share price is heavily dependent on coronavirus vaccine news.
That said, more aggressive investors should consider buying Novavax after recent share declines. In the near term, any good news on the coronavirus vaccine candidate could push the stock higher. Whether we end up with a Biden or Trump administration, both would probably look to financially bolster companies that offer the most promising, safe, and effective vaccine candidates. And in the long term, NanoFlu, Novavax's flu vaccine candidate, should be another positive catalyst. NanoFlu met all primary endpoints in its phase 3 trial, including matching, sometimes even outperforming, the standard accepted flu vaccine's effectiveness. The next step is submission to the FDA for approval. If regulators give the NanoFlu vaccine the nod, and if Novavax finishes the coronavirus vaccine race among its leaders, this biotech company's future is sure to be bright well past election day.
