(HealthNewsDigest.com) - A low-cost COVID-19 vaccine candidate that could be produced in the United States and worldwide using existing influenza virus manufacturing infrastructure has been developed by researchers at Icahn School of Medicine at Mount Sinai, with the potential to rapidly produce hundreds of millions of vaccine doses to mitigate the impact of the current pandemic and future viral outbreaks. The vaccine, which works the same way many flu vaccines do, is undergoing clinical development planning in several countries (including Mexico) through a licensing agreement with Mount Sinai. Early-stage clinical trials are also underway at Mount Sinai Health System in New York.

“To contain the spread of the virus worldwide, a vaccine that is both effective and cost-effective is urgently needed, especially in low- and middle-income countries with limited resources,” says Peter Palese, MD, Horace W. Goldsmith Professor and Chair of Microbiology at Icahn Mount Sinai, and senior author of two studies examining the effects of so-called Newcastle disease virus (NDV) vaccines in animal models (EBioMedicine, November 2020, and Vaccines, December 2020). “Our work suggests that an NDV-based vaccine, which can be produced from embryonated chicken eggs, would be a safe and highly scalable way to meet the vast demands of the global vaccine market.”

Most COVID-19 vaccines work by exposing people to the “spike” protein, an important part of the structure of SARS-CoV-2, the virus that causes COVID-19. But they differ in how they get the spike protein into the recipient. Mount Sinai’s vaccine works by introducing the spike protein into the body via the harmless NDV virus, prompting the body’s cells to make copies of the spike protein. When this occurs, the immune system begins to produce antibodies and T cells to specifically target the spike protein; these will neutralize any foreign intruder, like SARS-CoV-2, that contains it.

The NDV vaccine against SARS-CoV-2 was created by a globally recognized team of virologists from Mount Sinai, including Dr. Palese; Florian Krammer, PhD, Mount Sinai Professor in Vaccinology; and Adolfo Garcia-Sastre, PhD, Irene and Dr. Arthur M. Fishberg Professor of Medicine and Director of the Global Health and Emerging Pathogens Institute at Mount Sinai. “Our study demonstrated that the neutralizing antibodies produced by the NDV vaccine provided strong protection in animal models from SARS-CoV-2 infection,” notes Dr. Krammer. “Also, because the NDV is not a human pathogen, the spike antigen could be delivered more efficiently and without being compromised by any pre-existing immunity in humans. Another advantage is the fact that NDV-based vaccines have been tested extensively in human trials and have compiled a very good safety record over the years.”

In Mexico, a licensing agreement between Mount Sinai and Laboratorio Avi-Mex S.A. de C.V. (Avimex), a veterinary pharmaceutical company, will enable that country to soon begin Phase 1 trials in humans of a COVID-19 vaccine using NDV vector technology. Avimex began collaborating with Mount Sinai in 2003 on developing veterinary influenza vaccines and has since produced millions of doses based on the NDV vector platform.

“Being able to vaccinate populations in all parts of the world, and not just those in high-income countries, is critical if we’re going to establish herd immunity and contain the spread of COVID-19,” says Dr. Palese. “We believe that NDV-based vaccines can be a vital part of the solution. They could lead to vaccination of a large percentage of the world’s population over a very short period by using existing technology and infrastructure in a highly cost-effective, efficient, and safe way.”