PITTSBURGH – In two previous viral outbreaks, spanning almost 20 years, researchers at the University of Pittsburgh worked to develop vaccines.

That experience served them well in the race to develop a preventative treatment for the novel coronavirus. After working on the problem for a little more than two months, the University of Pittsburgh School of Medicine announced Thursday that it has had successful trials in mice with a COVID-19 vaccine.

Dr. Andrea Gambotto, a senior author on the paper outlining the vaccine's animal trials, said the researchers had worked on vaccines for SARS-CoV in 2003 and MERS-CoV in 2014. Both of those viruses are similar to SARS-CoV-2, known as the novel coronavirus.

"Those two vaccines taught us how to transfer all these findings for the new SARS coronavirus 2 vaccine," Gambotto said Thursday at a press conference announcing the advancement.

Gambotto, associate professor of surgery at the University of Pittsburgh School of Medicine, worked on the paper with Dr. Louis Falo, a professor and chairman of dermatology at the University of Pittsburgh School of Medicine and UPMC. The paper was released today by EBioMedicine, which is published by the British leading medical journal The Lancet.

Falo said the vaccine project leaders are seeking approval from the U.S. Food and Drug Administration for human clinical trials. Normally, the process for developing a vaccine would take up to two years.

"But these pandemic conditions are not normal," Falo said Thursday in a press conference to announce the vaccine development. "We are speaking with the FDA, and we're hoping to start this process as soon as possible."

The human clinical tests would focus on healthy people in the Pittsburgh region, he said.

During tests in mice, the vaccine was shown to produce antibodies specific to SARS-CoV-2, known as the novel coronavirus. Falo and Gambotto said the mice responded with antibodies sufficient to neutralize the virus.

The University of Pittsburgh team began work on Jan. 21 with the COVID-19 vaccine.

"We were able to plug into existing tools quickly and develop a vaccine," Gambotto said.

The researchers are calling the vaccine PittCoVacc, short for Pittsburgh Coronavirus Vaccine. The process uses laboratory-made pieces of viral protein to build immunity, similar to the process of annual vaccinations for the flu.

This differs from the experimental vaccines, which focus on RNA development, that have recently entered clinical trials.

Again, the University of Pittsburgh team drew on its previous experience in the 2003 SARS outbreak. During the research 17 years ago, Gambotto said he realized that the spike protein effectively targeted coronavirus. 

For delivery, the vaccine uses a microneedle array, a fingertip-sized patch of 400 tiny needles that deliver the spike protein, embedded in a sugar-like substance into the skin. The patch, similar to an adhesive bandage, is affixed to the patient and the needles, which are made of sugar, dissolve into the skin.

"The skin is our first line of defense versus bacteria, versus viruses and other harmful invaders. Because of that, it has evolved to be very efficient at mounting an immune response," Falo said. "What the microneedle array is able to do is deliver the vaccine antigen directly to the areas that are made to make an immune response."

He said the vaccine would also be easily mass-produced if it turns out to be successful because of its simple design. In the university's lab, a person can make hundreds of the microneedle applicators using molds. The vaccine also is shelf-safe and does not require refrigeration.

Additional authors on the study are Eun Kim, Geza Erdos, Shohua Huang, Thomas Kenniston, Stephen Balmert, Cara Donahue Carey, Michael Epperly, William Klimstra and Emrullah Korkmaz of Pitt and Bart Haagmans of Erasmus Medical Center.

Funding for the study came from the National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases and National Cancer Institute.

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