On Friday, I wrote about the late, great Dr. Jonas Salk, whose polio vaccine developed at the University of Pittsburgh 65 years ago this month saved humanity from a virulent killer. That piece, “Seeking Another Jonas Salk,” concluded by saying that somewhere in a lab somewhere in America there may be another Salk ready to emerge.
“Who will it be?” I asked. “When?”
The irony of that piece is remarkable. As my editor at The American Spectator was framing that column for posting, researchers at no less than Pitt Medical School and the University of Pittsburgh Medical Center held a press conference announcing the first major candidate for a COVID-19 vaccine. This wasn’t a mere discussion about finding a vaccine. Pitt’s researchers may have already developed it. They are much further along than anyone anticipated. What they announced wasn’t hype. This could be the real deal, and it may move far faster than anyone would have expected for such a thing.
Specifically, the University of Pittsburgh School of Medicine scientists announced a potential vaccine against “SARS-CoV-2,” which is the technical name of the new coronavirus causing the COVID-19 pandemic. When tested in mice, the vaccine, which is delivered through a fingertip-sized patch, produces antibodies specific to SARS-CoV-2 in quantities that (according to Pitt’s researchers) “are thought to be sufficient for neutralizing the virus.” They published their results in the April 2 issue of eBioMedicine, the online version of the longtime British medical journal, the Lancet.
The official language opening the press conference cautiously affirmed that Pitt’s scientists are “working toward a vaccine.” But the actual substance suggests they’re much further along. How so? Because the researchers had already laid the groundwork during earlier coronavirus epidemics.
“We had previous experience on SARS-CoV in 2003 and MERS-CoV in 2014,” said Dr. Andrea Gambotto, associate professor of surgery at the Pitt School of Medicine and co-author of the published paper (and, fittingly, a native of Italy). “These two viruses, which are closely related to SARS-CoV-2, teach us that a particular protein, called a spike protein, is important for inducing immunity against the virus. We knew exactly where to fight this new virus.”
Thus, when the genetic sequencing for the current COVID-19 virus was identified earlier this year, in January, notes Gambotto, “we were able to plug into our existing tool and rapidly produce a vaccine.”
The vaccine is being called “PittCoVacc.” The researchers use an innovative approach to deliver the drug, something called a “microneedle array,” to increase potency. This array is a fingertip-sized patch of 400 tiny needles that delivers the spike protein pieces into the skin, where the immune reaction is strongest. The patch goes on like a Band-Aid, applied to the skin topically. The needles, which are made entirely of sugar and the protein pieces, simply dissolve into the skin.
“We developed this to build on the original scratch method used to deliver the smallpox vaccine to the skin, but as a high-tech version that is more efficient and reproducible patient to patient,” says Dr. Louis Falo, M.D., Ph.D., professor and chair of dermatology at Pitt’s School of Medicine and University of Pittsburgh Medical Center. “And it’s actually pretty painless — it feels kind of like Velcro.”
The skin is the first line of defense against invaders, and this bolsters the skin for a very strong response. When tested in mice, PittCoVacc generated a surge of antibodies against SARS-CoV-2 within two weeks of the microneedle prick.
Also significant, the Pitt researchers believe that the vaccine can be easily manufactured to scale. Unlike many other vaccines, it doesn’t need to be refrigerated or frozen; it can be stored on a shelf like a Band-Aid, making it easier for shipping and distribution worldwide.
The authors are now in the process of applying for a so-called “investigational new drug” (IND) approval from the FDA in the hopes of initiating a “phase I human clinical trial” within “the next few months.” There’s an obvious urgency. “Testing in patients would typically require at least a year and probably longer,” says Falo. “This particular situation is different from anything we’ve ever seen, so we don’t know how long the clinical development process will take. Recently announced revisions to the normal processes suggest we may be able to advance this faster.” This process usually takes “months to years,” says Falo, “but these pandemic conditions are not normal.” The process needs to be accelerated “as quickly as possible.”
Exactly. That being the case, the feds need to move. This is legit. Pitt’s researchers did much of the research previously. It would be damned nice if the FDA could truly fast-track this.
Interestingly, in light of my Jonas Salk piece, Dr. Falo opened the press conference with reference to Salk’s breakthrough: “This is also the same place where Dr. Jonas Salk invented the polio vaccine 65 years ago, dropping the number of disabling or deadly cases from more than 55,000 per year to essentially none today.”
The call remains: we’re seeking another Jonas Salk. Well, Salk’s heirs at the University of Pittsburgh may have already stepped up. The key questions are how close are they, and how quickly can people begin getting inoculated? The FDA needs to watch the Pitt crew carefully and be ready to act quickly.