After an FDA panel “unanimously” voted to recommend that the agency approved Novavax’s (NASDAQ:NVAX) coronavirus vaccine, the outlook of NVAX stock has significantly improved. Nonetheless, I believe that the shares remain risky, and I recommend that only speculative, risk-tolerant investors buy them at this point.
An FDA Approval Is Probably Assured, But Other Risks Remain
Multiple news outlets have emphasized that the FDA almost always follows the recommendations of its panels. What’s more, since the panel’s vote was unanimous, it is particularly unlikely for the agency to go against the panel’s recommendation on Novavax’s shot.
Also noteworthy is that the leader of the FDA’s own vaccine review division urged the panel to back the shot, saying that it would be useful, given the significant percentage of Americans who have not yet gotten a coronavirus jab.
Some people, including myself, have theorized that many Americans may be more likely to be open to getting Novavax’s shot, which is based on fairly old-fashioned technology, than the vaccines of Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA), which are based on much newer technology known as mRNA).
Given all of these points, I would be very surprised if the FDA elects not to approve Novavax’s shot.
Uncertain Orders From Washington and Possible Stronger Foreign Sales
The fact that FDA officials often have conflicts of interest, especially when it comes to regulating large pharmaceutical companies, is fairly well-known and accepted. Not only do such firms’ fees now pay a large portion of the FDA’s “drug review” budget, but it’s not unusual for former top FDA officials to work at major drug companies after their tenures at the regulatory agencies have ended.
Additionally, as I’ve pointed out in the past, large pharmaceutical companies contributed a significant amount of money to federal Democratic candidates in 2020. Obviously, Pfizer and Moderna do not want Novavax to become a popular vaccine in the U.S. because they would lose significant amounts of revenue if such a scenario materializes.
Meanwhile, in my opinion, the mainstream media’s coverage of Novavax’s shot has generally been much less favorable than their articles about the shots of Pfizer and Moderna were. For example, in stories about Novavax’s shot, there have been many more prominent mentions of a rare heart condition called myocarditis than the articles I’ve seen about the jabs from Pfizer and Moderna, even though all three shots may elevate the risk that young men will contract the disease.
Taking all of these factors into account, I think there’s a meaningfully greater than 50% chance that the U.S. government will order relatively few shots from Novavax this year. Additionally, the FDA could include a warning on Novavax’s label that will make it less appealing to many consumers.
On the other hand, if Novavax’s combined flu-and-coronavirus vaccine is approved meaningfully before the similar shots of its competitors are, I believe that popular pressure could very well force Washington to buy a great deal of Novavax’s shots. And since Novavax reportedly has a chronological lead when it comes to those shots, that scenario could very well occur.
Also worth considering is that the (probably) imminent FDA approval could very well give Novavax a great deal of positive publicity in overseas markets in which its shot is already approved. Consequently, the demand for the company’s shot in those countries could jump in the coming months. On the other hand, however, that trend could be tempered by the somewhat negative press that the shot is receiving from the American media.
And with the market capitalization of NVAX stock standing around $4 billion as of the afternoon of June 8 , the shares are pricing in a relatively low volume of new orders of the company’s shot. Still, given the many variables, risks and moving parts that can affect Novava’s shares in the future, the shares are not a good pick for risk-averse investors and should only be bought by speculative, risk-tolerant investors.
On the date of publication, Larry Ramer was long NVAX stock. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.