Despite the Trump administration’s best efforts with Operation Warp Speed, a novel coronavirus vaccine probably won’t be available until after the Nov. 3 election. Although the demand is tremendous for a safe and viable vaccine, the reality is that normally, this process takes years to research, develop and distribute. At the same time, this complexity also keeps biotechnology firms like Novavax (NASDAQ:NVAX) in the running.
As you may know, the vaccine race features not only several organizations but multiple methodologies. For Novavax, it’s going with a process called subunit vaccines. In short, this approach takes protein fragments (subunits) of the SARS-CoV-2 virus and injects them into the patient. From there, the patient’s cells take the gene sequence of the novel coronavirus to initiate a complex process, the end result being the production of antibodies that bind to the virus’ spike proteins, preventing infection of healthy cells.
In this manner, it’s similar to traditional vaccines, which use a weakened or inactivated (dead) form of the virus to introduce to the body. However, the key difference again is that rather than injecting the whole virus, subunit vaccines involve fragments of it.
Logically, given the historical track record of traditional vaccines, Novavax’s approach should theoretically be the most effective. As added support, this newer process has precedent of its own. According to the Washington Post, the hepatitis B vaccine incorporates subunits manufactured by genetically engineered yeast.
But if traditional vaccines have the most credibility, why not go with this approach? Unfortunately, such vaccines take too long to develop, likely leaving them out of the running. Still, subunits have their own issues that make them susceptible to competitive threats.
Where NVAX May Fall Short
What makes the vaccine race a perplexing one both on the scientific and investment front is that no candidate has an exclusive path to comprehensive efficacy, safety and scalability. All three components have to be in strong, balanced proportions for a candidate to be declared a decisive winner.
Frankly, you’re not going to get that with Novavax’s subunit vaccine. While it ranks strongly in the efficacy department, a known issue with subunits is low immunogenicity, requiring an adjuvant, or an agent that improves the immune response of a vaccine. Indeed, a peer review study by the New England Journal of Medicine of Novavax’s candidate (NVX-CoV2373) demonstrated that with an adjuvant, the vaccine produced high titers of antibodies.
Without an adjuvant, the titer data was far less impressive.
But before you rush to buy shares of NVAX, you may want to consider the other glaring issue: NVX-CoV2373 will likely require two doses to truly be effective. As the NEJM study demonstrated, antibody titers were greatest with two doses.
Unfortunately, that presents some major issues. Obviously, the patient must be willing to come back to the clinic for a second go. But more pressing concerns relate to maintaining enough supply for both doses and long-term storage stability. Though subunits are generally more stable than other vaccine types, there may be a risk associated with potency loss, especially with improper storage. Additionally, I noted the following:
…an unfortunate disadvantage is that subunits and Novavax’s candidate in particular may be more expensive. The manufacturing process to develop the underlying nanoparticles is more involved than producing the traditional oligonucleotides that may be used in nucleic-acid vaccines.
Further, while governmental support may make the cost argument a moot point, what cannot be swept under the rug is the manufacturing requirements. The subunit vaccine production process is unique and Novavax may need to build out more manufacturing capacity. That takes time, which is a luxury we don’t have.
And these inconveniences and disadvantages may give life to another competitor, Johnson & Johnson (NYSE:JNJ).
A Pharmaceutical Giant Throws Its Hat into the Ring
Seemingly out of nowhere, Johnson & Johnson recently received the green light to go into Phase 3 trial for its Covid-19 vaccine candidate. Of course, the abruptness is just perception. More than a few times in InvestorPlace articles, I mentioned that JNJ could be a pandemic winner. Basically, by developing a Covid vaccine, it can generate positive PR, thereby helping to repair a once-trusted brand impugned by several inexplicable scandals.
But what really brightens the narrative for Johnson & Johnson – and subsequently, darkens it for Novavax and others – is that the JNJ candidate is a one-and-done deal. That is a huge advantage because you can focus credibly on widespread immunization. Unlike Novavax and other leaders, such as Moderna (NASDAQ:MRNA) and its messenger RNA vaccine candidate, Johnson & Johnson won’t have to manufacture essentially two vaccines.
As a bonus, the JNJ vaccine won’t have to be frozen, eliminating a major logistical hurdle, particularly for less-developed nations. While I’m not 100% clear about NVX- CoV2373’s storage and management requirements, its likely two-dose regimen invariably puts it at a disadvantage to Johnson & Johnson.
Finally, JNJ features world-class manufacturing capabilities. If its candidate is approved, that could be game over for most other competitors. I hate to sound like a broken record, but its one-dose potency makes two-dose proposals almost antiquated, like a rotary phone.
As if to pour salt on its rivals’ wounds, JNJ’s early trial data shows that the vaccine was well tolerated among nearly all participants. So, should investors abandon the case for NVAX and other two-dose vaccines?
Not so fast. Even with Johnson & Johnson, some questions exist. Here, it’s the lack of a peer review regarding its candidate’s outstanding attributes. Thus, Phase 3 should tell us whether it’s a contender or pretender.
Vaccines Cannot Ignore Inclusivity
But even if JNJ or another company beats Novavax to the finishing line, a truly effective vaccine will feature inclusivity. Given the history of medical racism in the U.S., many Black doctors want to vet the vaccine process, according to a recent report from the Washington Post.
Certainly, reasonable people can appreciate where these doctors are coming from. Sadly, many experiments that have been conducted on Black participants were deeply unethical, creating generational mistrust toward the medical industry. That’s why I thought it was incredibly significant for Moderna to push for diversity in its participant base.
Given the disproportionate impact of the novel coronavirus on communities of color, it’s vital that vaccines be safe and accessible. Coincidentally, a critical advantage to Moderna’s mRNA-based vaccine is its ease of manufacturing relative to other approaches.
However, nucleic-acid vaccines have never been approved by the Food and Drug Administration. Therefore, this method is the most experimental. While available data is encouraging, I can understand how the idea of using experimental vaccines, especially with communities of color, may raise eyebrows.
At the same time, I believe the bigger issue regarding diversity is more accessibility than viability. According to a race-related antibody response study published by the National Institutes of Health, race and “ethnicity can influence immune responses to vaccination.” Specifically, this study demonstrated “higher antibody responses to the influenza A virus components…in African Americans as compared to Caucasians.”
In other words, science suggests that Blacks physically on average have more robust genes than other races. While this sounds controversial, please note that this is the true underlying theme of Jordan Peele’s brilliant movie Get Out, which was attempting to subtly explain (through a fictional tale) the unusually high rate of missing Black youths.
Over the last several decades, many Black people have been subjected to medical experiments without their consent. What Get Out portrayed was the free market value for Black bodies, which, due to circumstances like melanin being incredibly expensive, make them ideal targets for profiteering.
Again, Get Out is fiction, but watch that auction scene again. This is about as powerful of a sociological statement as any director has made this century, in my humble opinion.
I mention this because likely, based on multiple scientific studies, Blacks should respond very well to a coronavirus vaccine. But their understandable lack of trust toward the medical system may end up exacerbating the crisis in their communities.
Therefore, a truly holistic vaccine will have addressed the serious concerns of Black medical experts and community leaders.
This Competition Is Wide Open
Where does this leave Novavax? Having performed substantial research into this topic, not only from a scientific perspective but social as well, what I can tell you with reasonable confidence is that NVAX has a shot. As I’ve said in recent articles, no one solution is the end-all, be-all.
True, Johnson & Johnson looks to be a significant factor. However, the lack of peer review makes its candidate risky compared to vaccines that have undergone such analysis. Further, Novavax’s utilization of the more proven subunit method should give it an edge among communities of color leery about experimental vaccines.
But if this write-up has proven anything, it’s that this competition is anything but secured. I’m afraid that’s all I can say until we receive further news down the road.
On the date of publication, Josh Enomoto did not have (either directly or indirectly) any positions in the securities mentioned in this article.
A former senior business analyst for Sony Electronics, Josh Enomoto has helped broker major contracts with Fortune Global 500 companies. Over the past several years, he has delivered unique, critical insights for the investment markets, as well as various other industries including legal, construction management, and healthcare.