The AAVCOVID vaccine program Massachusetts Eye and Ear and, Massachusetts General Hospital, members of Mass General Brigham, has entered into a manufacturing agreement to produce its novel genetic vaccine with an industry leader in gene therapy, AveXis, a Novartis Company. AveXis will begin manufacturing the vaccine this month while AAVCOVID undergoes further safety and efficacy testing in preclinical studies taking place at academic medical institutions including Mass. Eye and Ear.

AveXis, will lead the manufacturing efforts of the new vaccine, utilizing its cutting-edge AAV technology for treatment of rare and life-threatening neurological genetic diseases. AveXis is one of the first companies in the world to have successfully scaled up gene therapy manufacturing with over 1 million square feet of manufacturing capacity.
Through this strategic partnership, AveXis is contributing its technology, expertise and supply chain at no cost to supply the AAV vaccine for COVID clinical trials scheduled to begin in the second half of 2020.

“The COVID-19 pandemic is the most urgent public health crisis of our time and we recognize the significance of evaluating the potential role of a gene-based vaccine,” said Dave Lennon, president of AveXis. “As one of the world’s leading gene therapy companies, we are pleased to lend our unparalleled manufacturing expertise, technology and supply chain to produce a COVID vaccine for use in clinical trials. Having developed and produced one of just two, FDA-approved AAV gene therapies, we are uniquely poised to help the team move quickly toward this accelerated effort.”

The AAVCOVID vaccine program was developed in the laboratory of Luk H. Vandenberghe, PhD, director of the Grousbeck Gene Therapy Center at Massachusetts Eye and Ear and Associate Professor of Ophthalmology at Harvard Medical School. The experimental vaccine uses an AAV vector to deliver the genetic code to produce protein fragments of the SARS-CoV-2 virus, the cause of COVID-19 disease, to elicit an immune response. Mason Freeman, MD, director and founder of the MGH Translational Research Center and a Professor of Medicine at Harvard Medical School, is leading the efforts to develop the clinical studies intended to establish safety and efficacy of the experimental vaccine. Once these early studies are completed, including the first clinical trials, the researchers aim to advance the study into later phases. AveXis has the option to manufacture the AAV vaccine for additional clinical development, registration and/or commercial activities.

Mass. Eye and Ear and Mass General are member hospitals of Mass General Brigham.
“There are many vaccine approaches to COVID-19 with great promise, but often the first question that gets asked is, ‘how can this vaccine be scaled to the millions of doses needed to prevent a worldwide pandemic?’” said Dr. Vandenberghe. “By partnering with an industry leader in AveXis that already produces AAV gene therapy products at large scales, we are more on track than ever to reach our goal of developing a vaccine capable for wide distribution to prevent infection at population levels.”