New York, New York--(Newsfile Corp. - November 17, 2020) - Enthusiasm is surrounding Pfizer's and Moderna's announcement of COVID-19 vaccine candidates that may soon become ripe for approval. But, in all fairness to the progress, tempering some of the excitement is warranted.
There are two significant concerns. First, both Pfizer and Moderna candidates use synthetic mRNA technology to activate the immune system against the virus and must be kept at minus 70 degrees Celsius (-94 F) or below, or at refrigerated levels for no more than 30 days and freezing at -20 degrees Celsius, respectively.
Second, mRNA technology has never been approved as a vaccine previously, meaning that both short and long-term safety risks are not as well understood. Moreover, this may have particular implications for repeated use of the vaccine (e.g., should yearly vaccinations be required).
As a first-generation submission, the mRNA vaccine candidates should be applauded. But, the next-generation of heat-stable alternatives, like Soligenix's (NASDAQ: SNGX) CiVax, may offer a better and more viable platform to meet global dosing initiatives. That premise is supported in a Reuters' article that quoted Amesh Adalja, senior scholar at Johns Hopkins Center for Health Security, as saying, "The cold chain is going to be one of the most challenging aspects of the delivery of this vaccination...and this will be a challenge in all settings because hospitals even in big cities do not have storage facilities for a vaccine at that ultra-low temperature."
The article also noted that even one of the most prestigious U.S. hospitals, the Mayo Clinic in Rochester, Minnesota, does not currently have that capability. Therefore, don't count on your local pharmacy, grocery chain, or town hospital to have the equipment to store the vaccine either. But, that need may not be necessary.
NASDAQ traded Soligenix believes it can alleviate much of that logistical pressure if its next-generation heat-stable subunit vaccine, CiVax for COVID-19, continues to score preclinical wins.
CiVax Potential May Clear Logistical Obstacles
In light of news about Pfizer's vaccine facing potentially restrictive dosing challenges due to it requiring freezing, and Moderna's requiring strict cold-storage temperature guidelines, CiVax is again earning attention as a next-generation vaccine that can be stored at room temperature. While that inherent value is undoubtedly a compelling feature, more critical to the drug's chances for approval is that CiVax is a subunit vaccine with a known and well-tolerated safety profile that can benefit from accelerated development considerations through partnerships, licensing, or government funding.
That advantage should cause pause for the millions of people around the world who will take the first available vaccine, regardless of how it's made. Of particular value for them would be to distinguish that the CiVax subunit vaccine does not use live-virus components. That may be the most compelling argument in favor of considering how a CiVax solution compares against dosing a billion people with the Pfizer or Moderna candidate with multiple unknowns.
A year from now, absolutely nobody knows the potential after-dosing effects of either the Pfizer or Moderna vaccine candidate. That's probably not the case with Soligenix's subunit vaccine since subunit proteins have been used for decades. It also differs substantially from inactivated whole-cell vaccines by including only the pathogen's antigenic parts -- the parts necessary to elicit a protective immune response. Thus, the vaccine's premise may be safer from the start and provide a similar therapeutic value.
Moreover, subunit vaccine candidates, like CiVax, are safe and follow a long list of vaccines that have been universally well-tolerated and effective for decades.
More Factors In Favor Of CiVax
The arguments against speed over potential efficacy are warranted. After all, before potentially growing an extra ear three years from now because a pharmacy technician allowed the cold-chain to break, it's essential to look at feasible alternatives. In that measure, CiVax can check off many of the boxes that the Pfizer and Moderna drug does not.
First, CiVax utilizes a protein subunit antigen with a novel adjuvant that has long been considered the gold standard for vaccine safety. Second, CiVax has demonstrated the ability to stimulate Th1 antibody responses, unlike the standard subunit vaccine adjuvant. These preferred Th1 antibody responses have already been generated for vaccines to treat SARS and MERS -- that bodes well for CiVax. And if those actions are replicated, it may closely mimic the Pfizer and Moderna immune-boosting applicant's effects.
Also noteworthy is that CiVax demonstrated the ability to generate both neutralizing antibodies AND cell-mediated immunity - both of which are considered critical to generating a potent immune response. Better still is that robust responses were measured even after one vaccination. Thus, a single dose CiVax vaccine may be feasible.
The differences may be better shown in comparison. If a (-94 F) drug is challenging to deliver as a single dose, the subsequent effort to re-dose the population can present insurmountable challenges even in perfect conditions. And, circumstances that allow for even minimal refrigerated conditions won't exist for most of the world's population, especially those outside of metropolitan areas or who live in remote regions of the world. That leaves billions of people exposed...and untreatable.
Meeting Rapid Scale-Up Challenges
Aside from the potential logistical nightmare of a vaccine requiring (-94 F), or -20 degrees Celsius, to stay potent, producing the vaccine presents another set of challenges. While this can be met with licensing agreements, consider that each manufacturing facility will also face rigorous FDA review and oversight. Reproducing a complex, highly intolerant vaccine is not like replicating a potato chip. It's a too complicated process that has many moving parts to earn even a GMP approval. CiVax clears that hurdle as well.
CiVax utilizes an approach that can rapidly scale up production using different facilities with minimal supply chain overlap. Moreover, the platform can be used as many times as desired, yearly, for example, if there are genetic drifts or mutations in the virus. Also, checking off another unknown against competing vaccine candidates is that CiVax is likely to be equally effective for elderly and immune-compromised individuals with no safety constraints anticipated.
Maybe most important to the subject is that most vaccine efforts are based on inactivated coronavirus, meaning developers will need significant stocks of the virus to produce their product. That factor presents a host of potential complications. Also, with no vaccines to date getting approved using DNA or RNA technologies, even a successful formula can limit their use and be entirely contraindicated in some populations.
CiVax, again, is showing its ability to meet and beat these challenges. It is also one of the only vaccine candidates showing the potential to generate a thermostabilized vaccine - meaning no cold chain distribution is required and can be easy to distribute worldwide. In other words, it can be produced and sent to many millions of patients quickly and efficiently without the fear of losing its potency.
CiVax Taking Steps Forward
It's fair to take a challenging viewpoint to the Pfizer and Moderna vaccine candidates and, at the same time, appreciate the contribution. Operation warp-speed provides small and large drug development companies the opportunity to develop a promising drug in record time. But, that speed should not come without an abundance of caution. Injecting billions of people with a drug that has a limited long-term safety profile can cause generations worth of harm. That's the downside. The potential upside is that it works, and the world can move on from this debilitating pandemic.
It's also fair to note that alternatives are also advancing quickly, and CiVax is worthy of attention. And while Soligenix may not have the financial muscle of big pharma, they have routinely earned the attention from government agencies like the NIH, who have provided meaningful grants in the past based on the company's achievements. The company believes they can earn trust in its developing CiVax program.
Indeed, if CiVax continues to demonstrate an ability to effectuate immune responses, minimize storage concerns, and eliminate distribution constraints, it can likely be included for more funding. Keep in mind, too, that few in the health field expect a one-and-done vaccine approval. Several companies will need to contribute to beat COVID-19, and those contributions can come from companies big or small.
The bottom line is this... don't discount the value of Soligenix's contribution to producing a meaningful treatment for COVID-19. Its CiVax vaccine offers a bullish case to be included as a part of a global vaccination solution.
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