The Woodlands-based plasmid DNA manufacturer first announced it was producing a vaccine for the new coronavirus in late January, after it was selected by Inovio Pharmaceuticals as a production partner under a $9 million grant from the Oslo-based Coalition for Epidemic Preparedness Innovation.
“The dedicated team at VGXI has worked tirelessly to meet this challenge,” VGXI CEO Young Park said in a statement. “Within a fraction of the typical manufacturing timeline, VGXI has manufactured and released a vaccine for human clinical testing. We are proud to be a part of the global effort to address the COVID-19 pandemic.”
Inovio said its Investigational New Drug application for the vaccine had been approved by the U.S. Food and Drug Administration, and the first phase of clinical testing would begin April 6 at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia and the Center for Pharmaceutical Research in Kansas City, Missouri. VGXI said Inovio is also coordinating clinical trials in China and South Korea.
Initial results from the clinical trial of up to 40 volunteers are expected by late summer, Inovio said, with additional vaccine studies continuing alongside the clinical trial.
"We anticipate rapid enrollment of this initial study," said Dr. Pablo Tebas, a medical professor and infectious disease specialist at the Hospital of the University of Pennsylvania, in a statement. "There has been tremendous interest in this vaccine among people who want to do what they can to help protect the greater public from this pandemic as soon as possible."
VGXI said thousands of vaccine doses were produced within two months, up to four times faster than typical plasmid DNA production. The company has scheduled large-scale manufacturing of the vaccine in the second quarter this year, and Inovio said it plans to have 1 million doses of the vaccine available by the end of 2020 for further trials and possible emergency use.
"Producing a COVID-19 vaccine within the next 12 to 18 months is not only a scientific challenge; it will also require new levels of collaboration and investment across industry and government,” CEPI CEO Richard Hatchett said in a statement. “There is still a long road ahead before we have a safe, effective, and globally accessible vaccine ready for broader use, but today we have reached an important milestone on that journey."