Emerging Themes in the COVID-19 Vaccine Space (MRNA, PFE, DYAI, JNJ, NVAX, BNTX, AZN)

Pfizer and its partner, BioNTech, announced a few days ago that they plan to ask U.S. and European regulators to authorize a booster dose of their COVID-19 vaccine very soon. Why? They claim it is because of “evidence of greater risk of infection six months after inoculation and the spread of the highly contagious Delta variant”.

For most, it is hard to argue with the reasoning. Though it may seem like a financial or fiduciary risk on the part of taxpayers to simply accept this idea without more information.

First of all, because the process of producing and distributing the expensive and difficult-to-store and difficult-to-transport vaccine is far from simple and cheap. And, ultimately, we all know who will have to bear that cost.

For their parts, the FDA and CDC said, in a joint statement, that “Americans who have been fully vaccinated do not need a booster COVID-19 shot at this time”.

However, demand and future data will ultimately tell the tale. It’s likely a story that hasn’t been written yet, but one that has an unpleasant vector marked by the prospects of the variant tree continuing to yield new offspring that end up pushing the envelope past its secure boundaries.

In any event, it would be clearly beneficial to land upon a means of producing protection for the long term that doesn’t necessitate paying hundreds of billions of dollars every few months. Alas, the search goes on.

Impacted by this narrative are the usual suspects, including Moderna Inc (NASDAQ:MRNA), Pfizer Inc. (NYSE:PFE), Dyadic International, Inc. (NASDAQ:DYAI), Johnson & Johnson (NYSE:JNJ), Novavax, Inc. (NASDAQ:NVAX), BioNTech SE – ADR (NASDAQ:BNTX), and AstraZeneca plc (NASDAQ:AZN).

We take a closer look at some of the more interesting stories in this space below.

Moderna Inc (NASDAQ:MRNA) is perhaps the most prominent name in the COVID-19 space at this point because it was first-to-market in the revolutionary new mRNA vaccine space last fall and has been swallowing up the lion’s share of press on the subject ever since as a first mover. The company engages in the development of transformative medicines based on messenger ribonucleic acid (mRNA), according to its materials.

MRNA’s product pipeline includes the following modalities: prophylactic vaccines, cancer vaccines, intra-tumoral immuno-oncology, localized regenerative therapeutics, systemic secreted therapeutics, and systemic intracellular therapeutics.

Moderna Inc (NASDAQ:MRNA) recently announced a supply agreement with the government of Argentina for 20 million doses of Moderna’s COVID-19 vaccine or its updated variant booster vaccine candidate, if authorized, to begin delivery in the first quarter of 2022.

“We appreciate the support from the government of Argentina with this supply agreement for doses of the Moderna COVID-19 vaccine or our variant booster candidates,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are committed to making our vaccine available around the world as we seek to address the pandemic with our COVID-19 vaccine.”

MRNA shares have been acting reasonably well over recent days, up several percent in that time.

Moderna Inc (NASDAQ:MRNA) pulled in sales of $1.9B in its last reported quarterly financials. That pairs with some balance sheet hurdles, as cash levels struggle to keep up with current liabilities ($7.7B against $8.4B, respectively).

Dyadic International Inc (NASDAQ:DYAI) is a strong dark horse candidate in the race to reshape the global vaccine landscape. For a little background, DYAI has a new approach that could become a better way to deal with new variants and even possibly better able to drive cheap and efficient production capable of vaccinating the world.

The jewel in this new model is its proprietary process involving the C1 microorganism, which enables the development and large-scale manufacture of low-cost proteins and has the potential to be further developed into a safe and efficient expression system that may help speed up the development of biologic vaccines and drugs at commercial scales, while lowering production costs and improving performance at the same time.

To further advance this narrative, Dyadic International, Inc. (NASDAQ:DYAI) recently announced findings from the Zoonotic Anticipation and Preparedness Initiative (ZAPI) project which has been published in VACCINES, a leading peer-reviewed scientific journal.

“Zoonotic diseases represent a serious global threat to human and animal health. The majority of newly evolving pathogens are zoonotic viruses. Safe and effective vaccines that can be developed rapidly following an outbreak are required to effectively combat these diseases. The efficacy, protection and safety data reported from the ZAPI study further supports the mounting library of data – demonstrating a novel approach for the C1 expression platform to be broadly applied for rapid development and manufacturing of vaccines for both human and animals”. Dr. Tchelet further commented “we anticipate additional partnerships and external collaborations which will serve to further advance our commercial objectives”.

According to the release, the successful ZAPI program focused on the following goals to enable the delivery of targeted vaccines for humans and animals, as well as therapeutic antibodies for hospital use, rapidly following a future disease outbreak by identifying the best protective subunit vaccines and neutralizing antibodies against potential new zoonotic diseases or strains, such as bunyaviruses (i.e., Rift Valley fever virus and Schmallenberg virus) or coronaviruses (i.e., Middle East respiratory syndrome coronavirus or MERS Co-V); defining optimal manufacturing technologies and processes for these vaccines and antibodies to enable high-volume production capacity; obtaining alignment with regulatory authorities and policy makers; and securing pre-approval of new vaccine and antibody manufacturing methodologies for future emerging zoonotic viral diseases.

As noted by the company, this peer-reviewed study clearly seems to demonstrate the successful use of DYAI’s patented and proprietary C1-cell protein production platform to facilitate a fast, coordinated, and practical response to new infectious diseases as soon as they emerge – a striking advantage given infectious disease dynamics in the 21st century.

Dyadic International, Inc. (NASDAQ:DYAI) pulled in sales of $461K in its last reported quarterly financials. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($27.2M against $2.6M). However, the commercial opportunity is still ahead in this name as it works to secure a disruptive position in the global vaccine marketplace at a time when disruptive vaccine technology is at a powerful premium.

Novavax, Inc. (NASDAQ:NVAX) focuses on the discovery, development and commercialization of vaccines to prevent infectious diseases.

It provides vaccines for COVID-19, seasonal flu, respiratory syncytial virus, Ebola, and Middle East respiratory syndrome.

Novavax, Inc. (NASDAQ:NVAX) recently announced the publication of results from the final analysis of a pivotal Phase 3 clinical trial of its COVID-19 vaccine candidate conducted in the United Kingdom in the New England Journal of Medicine (NEJM). The final analysis confirmed an overall efficacy of 89.7% with over 60% (half) of the cases caused by the B.1.1.7 (Alpha) variant, and a 96.4% efficacy against non-B.1.1.7 (non-Alpha) variants which represents strains most similar to the original virus.

“We continue to be very encouraged by data showing high levels of efficacy against even mild disease, and that NVX-CoV2373 offers strong cross-protection against both the B.1.1.7 (Alpha) variant and non-B.1.1.7 (non-Alpha) variant strains which are widely circulating,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “This publication also reinforces the reassuring safety and efficacy profile shown in studies of our vaccine to-date and underscores the potential for NVX-CoV2373 to play an important role in solving this ongoing global public health crisis.”

While this is a clear factor, it has been incorporated into a trading tape characterized by a pretty dominant offer, which hasn’t been the type of action NVAX shareholders really want to see. In total, over the past five days, shares of the stock have dropped by roughly -13% on above average trading volume. All in all, not a particularly friendly tape, but one that may ultimately present some new opportunities.

Novavax, Inc. (NASDAQ:NVAX) pulled in sales of $447.2M in its last reported quarterly financials. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($2B against $1.2B).