Now That The FDA Approved Pfizer-BioNTech, Is This It For Vaccine Stocks?
This morning, something that most investors were expecting actually happened. Rumors had been abuzz with Pfizer (PFE) and BioNTech (BNTX) at the center of them. The expectation toward the end of the week last week was that the duo's COVID-19 vaccine would become the first to obtain real FDA approval. Sure enough, during the early morning hours of the market being open, the news was released that, in fact, the FDA approved their vaccine for use in those 16 and over. While the company continues pursuing an expanded approval for younger patient populations, the historic event markets a major milestone in the fight against the coronavirus. But does this mean all other companies developing a vaccine candidate should hang up their shoes and find something else to do? Absolutely not.
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In fact, if you look at where Moderna (MRNA) and Johnson & Johnson (JNJ) are, both companies are in the process of following suit with Pfizer/BioNTech. Moderna, for example, is still completing rolling data submissions. You've also got to remember that there are always opportunities to "make a better mousetrap" so to speak. Tylenol isn't the only pain/fever reducer, Robitussin isn't the only caught suppressant, and Claritin isn't the only allergy medication. If there's one thing to take away from any conversation about biotech stocks, it's that any company with their hat in the ring is likely making a version of something they hope to be better than the currently available method. Yes, this also pertains to diseases that have yet to see a viable treatment developed.
The current COVID landscape also has different variations of "vaccine stocks". Some companies are developing treatments for prevention like Pfizer/BioNTech, Moderna, JnJ, Astra Zeneca (AZN), etc. While others are pushing for drug candidates used by already hospitalized patients. Then you've got a slew of biotechs focusing on the byproducts of the virus. Things like acute respiratory distress syndrome ("ARDS") and other long haul or "long COVID" symptoms.
Long COVID Extends The Runway For Stocks
While people like Jim Cramer have their own COVID Index focused on a broad range of companies that could benefit from different phases of COVID, I'm talking specifically about companies that are looking to either develop a new/better vaccine and or treatments for long-haul COVID symptoms. For instance, earlier this summer, Tonix Pharmaceuticals Holding Corp. (TNXP) announced plans to develop TNX-102 SL for Long COVID syndrome in particular. The plan is to meet with the FDA this quarter to seek an agreement on the design of a Phase 2 study. The interesting part about TNX-102, like many experimental drugs during the pandemic, is that it's already begin studied in other indications. TNX-102 is in a Phase 3 trial for fibromyalgia. The company is also developing a specific COVID-19 pipeline that includes multiple candidates like TNX-1800, which was actually based on its horsepox virus vector, TNX-801. There's also TNX-2100, which is a diagnostic skin test.
Enlivex Therapeutics (ENLV) is another one of the companies looking into side-effects of COVID. In particular, this month the company was authorized by the Israeli Ministry of Health to begin a Phase 2b trial evaluating its Allocetra treatment in severe and critical COVID patients with acute respiratory distress syndrome.
You've also got other companies still working on a standard vaccine that not only addresses "OG coronavirus" but also all of the new variants coming out. These include the likes of Novavax (NVAX), Sorrento Therapeutics (SRNE), and Ocugen (OCGN), all of which continue making new headlines almost weekly at this point. Novavax, for instance, just reported that it expects late September or early October to be the time for new vaccine data to come out in the EU. All three of these stocks were considered penny stocks in early 2020, which shows just how big of an impact that coronavirus vaccine development has had on certain companies.
Are Coronavirus Stocks Too Risky?
This isn't to paint a picture of unicorns and rainbows for COVID stocks for years to come. However, the immediate future could present unique opportunities. The big thing you want to consider as an investor is "what else" is there? Are these companies just trying to take advantage of the virus right now or are there other pipeline candidates targeting other indications that could fill the void long after coronavirus is under control on a large scale? For instance, companies like Pfizer, Astra Zeneca, Johnson & Johnson, Novartis (NVS), Gilead (GILD), and many other market leaders may have exposure to vaccine development right now.
However, their robust pipelines make the COVID piece just a small portion of a much bigger pie. If any one of these companies' vaccine programs fails, there are still a plethora of other programs to fill any longer-term gap. For now, it's essentially a week-by-week thing. Following vaccine rates, new case numbers, hospitalization figures, and the death toll seem to sway related stocks in one direction or another. Since new cases don't seem to be slowing, there's a good chance that, at least for now, coronavirus stocks will be in the spotlight.