For COVID-19, Live Virus Vaccines Could Give Longer Term Protection Than the Current Warp Speed Vaccines — But They're Not Here Yet

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The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

The following article is sponsored by the clinical communications unit of Redington, Inc, which is paid by Tonix Pharmaceuticals Holding Corp. to provide investor communications services. The information contained in this article in no way represents investment advice or opinion on the part of Benzinga or its writers and is intended for informational purposes only.

Operation Warp Speed vaccines were available very rapidly, but they are starting to show their limitations, particularly their short duration of protection and the requirement for boosters.

This is the latest conclusion of the FDA, CDC, the White House, the Covid Response team, and a growing number of immunologists and medical specialists, including Seth Lederman, MD, CEO of Tonix Pharmaceuticals TNXP, whose company is developing a Covid-19 vaccine that has the potential to become a solution where others have left off.

Benzinga caught up with Dr. Lederman recently to find out more about what some investors had been thinking was a ‘too-late-to-the-party’ Covid-19 vaccine program.

“Clearly the Operation Warp Speed vaccines made a huge contribution to the health of the population and the recovery of the economy, but their limitations including durability of immunity may lead us to return to a new era of fear, as we learn whether and how effective they will be against emerging variants like Delta and whether boosters will be required indefinitely,” he said.

“Our approach to developing a Covid-19 vaccine took us back in history – roughly 225 years back—to Dr. Edward Jenner who developed a vaccine against smallpox, one of the most lethal viruses known to man. Because of his vaccine, smallpox has been deemed officially globally eradicated, making his vaccine the most successful vaccine ever.  It was also the first vaccine.”

Tonix updated Jenner’s basic technology, using a virus very similar to his as the vector, but added the payload of the SARS-CoV-2 spike protein.  SARS-CoV-2 is the virus that causes Covid-19.  Each of the Warp Speed vaccines is designed to express the spike protein of SARS-CoV-2, which induces the protective immune response.  The spike protein has been called the “payload” in all the current vaccines, although they employ different technologies to get it expressed.

Dr. Lederman said the overarching features of Jenner’s live virus technology is that a single shot provided immunity for decades, if not a lifetime, and prevented forward transmission, or the ability of an infected individual to transmit the disease to another person.

Tests at Southern Research showed that Tonix’s investigational vaccine, TNX-1800, protected upper and lower airways in monkeys challenged with live SARS-CoV-2, suggesting it could prevent forward transmission.

A live virus vaccine – such as TNX-1800 -- was one of four vaccine types on the Warp Speed’s short list of technologies it hoped could measure up to its mission. The other three technologies were mRNA, non-replicating virus and protein subunit. 

In a short period of time, vaccine candidates utilizing mRNA, non-replicating virus and protein subunits entered the clinic and went on to prove themselves as safe and efficacious. 

mRNA is the technology behind the vaccines from Pfizer and Moderna. Non-replicating virus vaccines from J&J and AstraZeneca were developed and J&J is marketed in the US, while AstraZeneca is available in other parts of the world. Novavax developed a subunit vaccine that appears to have good protection, but it also appears to be struggling with manufacturing issues delaying its approval.   

The fourth technology on the Warp Speed list – live virus vaccines—inherently take much longer to develop.  Live virus vaccines were outrun in the clinic by the first three. Merck had two potential live virus candidates but elected not to proceed with them.

The good news is the first Warp Speed vaccines got us over a big initial hurdle and bought time for more lasting solutions that will be required as the Covid-19 pandemic becomes endemic with new outbreaks of the disease occurring in different places in different times and spreading from place to place leaving death and disability in its wake, Dr. Lederman noted. 

“Our TNX-1800 vaccine is designed for the post pandemic world,” Dr. Lederman said.

Tonix said it is expecting to start a Phase 1 study of TNX-1800 in humans in the first half of 2022, less than a year from now. It is working on manufacturing the vaccine at the high level of quality required for human trials. 

Dr. Lederman explained that it takes time – and a lot of effort - to fully characterize live virus vaccine products and to get to the point where one can be responsibly studied in human volunteers in the U.S.

“In the short term, the development of manufacturing processes has slowed us down relative to the mRNA vaccines,” Dr. Lederman said. ”However, in the long-term, we believe a live virus vaccine should be easier to manufacture at scale and has several other appealing properties relative to the other vaccine technologies.”

In addition to their potential to confer decades of immunity, live virus vaccines offer other potential advantages relating to the cost of manufacturing, and the relative ease of storage and transport. They are produced in bioreactors and are not expected to require specialized refrigeration. 

Dr. Lederman concluded, “Live virus technology has brought us some of the most successful vaccines ever – not just smallpox, but also those for mumps, measles, and rubella.  Each of these have been proven to provide decades of immunity with a single shot.  For this and other reasons, we feel the live virus vaccine technology could make TNX-1800 a global product and make a global impact on Covid-19.” 

For more information on Tonix, click here. 

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

The author of this piece does not hold shares of any of the companies mentioned. Redington, Inc. employees and members of their families may from time own an equity interest in companies mentioned herein.