PITTSBURGH – A lead researcher on the University of Pittsburgh School of Medicine's COVID-19 vaccine project said the treatment is seeking approval from the U.S. Food and Drug Administration to begin clinical human trials.
Dr. Louis Falo, co-author of a paper published today that outlines successful animal trials for a potential vaccine, said the typical approval period for a treatment of this type would take almost 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."
Falo, fellow co-author Dr. Andrea Gambotto, and Dr. Donald Yealy, chairman of the UPMC and University of Pittsburgh's department of emergency medicine participated in the press conference to unveil the potential vaccine to treat the COVID-19 pandemic.
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 researchers released their findings today in a paper published in EBioMedicine, published by The Lancet, a leading British medical journal.
Dr. Andrea Gambotto, co-senior author of the paper, said the university researchers were able to move so quickly because they were already working on vaccines for similar viruses.
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.
For delivery, the vaccine uses a microneedle array, a fingertip-sized patch of 400 tiny needles that deliver the spike protein 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.
Falo 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-save 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.