A Long Island biotechnology company's intranasal COVID-19 vaccine candidate has been chosen to be among four in an international clinical trial to be rolled out this summer by the World Health Organization.
The WHO Solidarity Trial will enroll about 20,000 volunteers aged 16 and over in Africa, Asia and South America who have not received a COVID-19 vaccine or been infected with the virus. The trial is designed to identify second-generation vaccines that are effective against new variants, provide extended protection and can be easily stored, transported and administered.
J. Robert Coleman, co-founder and chief executive of Farmingdale-based Codagenix Inc., said the company's candidate has inherent advantages because it is delivered as nose drops, providing a barrier against the virus, and can be stored and transported with standard refrigeration.
Introducing the vaccine through the nose "will induce mucosal antibodies and cellular immune cells" in the entire airway, including the mouth and throat, blocking pathways for infection, he said.
The vaccine, CoviLiv, "has the potential to break the transmission cycle" at the public health level, Coleman said. "If you can get a vaccine that you deliver through the nose, you can put a roadblock in the population."
Almost one billion people in lower-income countries remained unvaccinated as of May 22, according to the WHO, and only 57 countries have vaccinated 70% of their population. Almost 90% of the 163 clinical-phase vaccine candidates tracked by the agency are injected or taken as a pill. CoviLiv is one of only a handful delivered through the nose.
Vaccine candidates of: Inovio Pharmaceuticals Inc., based in Plymouth Meeting, Pennsylvania; Arcturus Therapeutics Holdings Inc., based in San Diego; and Medigen Vaccine Biologics Corp., based in Taipei, Taiwan, also will be included in the trial, according to the WHO.
A Phase 1 trial conducted in 2021 in the United Kingdom found CoviLiv induced a "potent immune response" against omicron and other variants of the virus, the company said.
A second trial is underway in the U.K. to test the vaccine's efficacy as a booster in adults who were previously vaccinated.
Coleman said that the private company has grown to 38 employees. Though current funding is adequate, he said that Codagenix could seek additional financing by year's end.
Codagenix has partnered with Serum Institute of India, which says it is the world's largest manufacturer of vaccines by number of doses, to manufacture CoviLiv. The Serum Institute also will manufacture the COVID-19 vaccine developed by Gaithersburg, Maryland-based Novavax Inc. That vaccine candidate Tuesday won the emergency-use recommendation of a key Food and Drug Administration advisory committee for distribution in the United States.
The Codagenix vaccine is made by rewriting the genetic code of the COVID-19 virus so it’s incapable of infecting humans, while maintaining its outward characteristics.
That process differs from some other vaccines that focus on a distinctive feature of the COVID-19 virus, such as the spike protein, to elicit an immune response. CoviLiv should provide protection without reformulation even as new variants come along, Coleman said.
When the pandemic hit, Codagenix "pivoted" from its prior research to work on a COVID-19 vaccine, Coleman said, but the company has resumed research on its other projects, including CodaLytic, a preclinical immunotherapy for breast cancer patients.