NJ pharma firm preps skin test to gauge COVID exposure, immunity
COVID-19 vaccines are available, and you may be one of the lucky people to have already received one or two doses as New Jersey joins the rest of the world in trying to curb the pandemic.
But while the Pfizer and Moderna shots have been proven effective and severe side effects are rare, a mystery that remains -- and which is part of the reason some say they still will not get the vaccine — is how long they provide immunity.
Dr. Seth Lederman, CEO of Chatham-based Tonix Pharmaceuticals, said that detail won't stop him personally from getting the vaccine as soon as he's able, but that a longer-term solution will eventually be needed.
Lederman said the simplest route is an infant-safe vaccine that can be given at birth and potentially provide life-long protection, but in the interim, perhaps a closer look at what fights off the coronavirus within the body will reveal some answers.
Instead of antibodies, Lederman proposes focusing on T-cells, and said Tonix is in conversations with the Food & Drug Administration about a skin test, TNX-2100, that would measure SARS-CoV-2 exposure and immunity.
Using that information, Tonix, which specializes in live-virus vaccines, would hope to be able to use T-cell immunity to initiate more lasting COVID treatment.
A live-virus shot, which Merck was attempting to develop before shelving the project after Pfizer and Moderna were approved, provides an overall more robust stimulation of the immune system.
"This is the time to step on the pedal with research on more vaccines, particularly ones that have the potential to provide longer immunity," Lederman said.
He said he has seen cases of one spouse contracting the virus and the other acting as caretaker for that person, and because of that prolonged exposure, developing T-cell immunity.
"Many people develop T-cell responses to CoV-2, and a strong T-cell response is a good indication of not going to the hospital and doing better," Lederman said. "Antibodies are a component of immunity to COVID, but they are certainly a biomarker to immunity to COVID."
According to Lederman, if the body has a long-term T-cell response, a person can also expect a more temporary antibody response.
The skin test as currently designed is simple, Lederman said, and can be done with little medical professional involvement.
Once a small amount of protein is injected into the skin of the forearm, similar to a tuberculosis test, a patient would need to wait 48 hours to see if a red, raised lesion forms. The patient would then record the width of the raised portion, which would stand as an indicator of immunity.
"People won't even have to come back to the doctor to see if they're positive or not," Lederman said. "They can measure it themselves, and if necessary for reporting requirements, they could take a picture on their phone or something."
The test, showing functional T-cell reactivity, would have the potential to be rapid and widespread, even in remote areas of the globe.
Lederman said the COVID-19 fire must be put out, and while it will take years to settle on which vaccine is best, even limited protection will make a big impact.
Tonix is hoping its dialogue with the FDA will lead to clinical trials this year and, if those conclude by next year, commercial availability of TNX-2100 by 2023.