As the coronavirus pandemic tears through the world, researchers at the University of Pittsburgh and UPMC have been racing to develop a potential coronavirus vaccine.
They developed what they’re calling a dissolvable microneedle array. It goes on like a band-aid, doesn’t require refrigeration and is more easily mass-produced than other vaccines. It’s called PittCoVacc, and has been tested successfully on mice.
“It is a band-aid-like patch that has hundreds of microscopic needles, made up of a sugar-like substance that rapidly dissolves in the body,” says Louis Falo, professor and chair of dermatology at UPMC. “And so the microneedle array is simply applied to the skin topically pressed into place very shortly. The vaccine is integrated into the needles; when pressed onto the skin, the needles penetrate the outer skin layer, and then dissolve and release the vaccine.”
Unlike most current vaccines, this vaccine doesn’t need to be kept frozen or refrigerated.
“It is shelf-stable at room temperature, like a band-aid, that reduces the shipping costs and supports vaccine distribution, particularly to less developed countries,” said Andrea Gambotto, associate professor of surgery at the University of Pittsburgh School of Medicine, who has spent his career developing vaccines.
The paper appeared today in EBioMedicine, which is published by The Lancet, and is the first study to be published after critique from fellow scientists at outside institutions that describes a candidate vaccine for COVID-19, according to a press release from UPMC. The researchers were able to act quickly because they had already laid the groundwork during earlier coronavirus epidemics.
“This vaccine is the result of a collaboration involving scientists from very diverse fields: skin biologists, bioengineers and biologists, all coming together to work towards a common goal,” says Falo. “That’s the type of collaborative environment we have here at Pitt and at UPMC. This is also the same place where Dr. Jonas Salk invented the polio vaccine nearly 65 years ago, dropping the number of disabling or deadly cases for more than 55,000 per year to essentially none today.”
The next step is a clinical trial.
“We are currently in contact with the FDA,” says Falo. “This process normally takes two years, but these pandemic conditions are not normal. The NIH the FDA and other regulatory agencies have made terrific progress in accelerating this process. Once we get approval from the FDA, we will be ready to start human safety trials.”
Work at UPMC on the SARS and MERS epidemics laid the groundwork for this vaccine’s development.
“When the genetic sequence for SARS coronavirus two was published late January this year, we were able to plug into our existing tools and rapidly produce a vaccine. So we use a genetically engineered cell to make a piece of the spike protein on the outside of SARS coronavirus two. This is the part of the virus that the immune system sees, and when that happened it triggered antibody production, which should protect against viral infection, and COVID-19 disease.”
The vaccine is designed to not make anyone sick after receiving it.
“So this vaccine is designed to be safe, in part because it delivers very low doses of antigens so much lower doses than the traditional flu vaccine,” says Falo. “Secondly, it delivers that antigen to a very confined space within the skin, so that it’s very unlikely that we would see any type of systemic responses that have been seen with some patients in the flu vaccine.”
Most estimates put a time frame for a vaccine development between 12 to 18 months.
“We are not trying to be evasive in terms of giving you a specific time line, the regulatory process is iterative and so how long the regulatory process takes depends on the feedback that we get during the process,” says Falo. “What I can tell you is once we have been given approval, we will be ready to go with the vaccine.”