WHO begins large-scale trial of LI biotech firm's intranasal COVID vaccine

The World Health Organization has begun giving volunteers the intranasal COVID-19 vaccine of Long Island biotech startup Codagenix Inc. in an international clinical trial, the company announced Wednesday.

The phase 3 trial, part of WHO's Solidarity COVID-19 vaccine program, will enroll as many as 20,000 participants in measuring the safety and efficacy of the vaccine, named CoviLiv. A phase 2 trial focused on safety had about 400 participants.

J. Robert Coleman, chief executive of Farmingdale-based Codagenix, said the intranasal vaccine has the potential to block transmission of the virus through the body's airways and may appeal to people who have "injection fatigue."

The dominant COVID-19 vaccines worldwide — including those made by Pfizer/BioNTech and Moderna — are administered by injection. A March National Institutes of Health report listed a dozen intranasal COVID-19 vaccines, including Codagenix's, under development worldwide. One, an intranasal version of the Oxford/AstraZeneca COVID-19 vaccine, failed in early trials, its developers said earlier this month.

The WHO trial is enrolling participants aged 16 or older who have not received a COVID-19 vaccine or had the virus before, according to the global health agency. The trial is being conducted in Africa and may extend to countries in Asia and South America. 

As of Monday, there were more than 624 million confirmed cases of COVID-19 worldwide and 6.6 million deaths reported to the WHO. Many researchers believe that official numbers, even in developed nations, undercount cases of the virus. For example, a 2021 study from the University of Washington estimated that the official numbers tallied in the United States undercounted cases by as much as 60%.

The WHO's Solidarity vaccine program is designed to identify next-generation vaccines that do not require extraordinary transport and storage arrangements and provide long-lasting protection against current and emerging variants of the virus.

At minimum, the WHO expects a vaccine to deliver a 50% lower risk that a person would get COVID-19.

The Pfizer/BioNTech and Moderna vaccines used in the United States elicit an immune response by delivering the distinctive COVID-19 spike protein to the immune system.

By contrast, Coleman said, Codagenix recodes the genetic material of the virus, leaving a live agent that can't cause disease, but can activate a broad immune response. Basing the vaccine on the entire virus should provide protection against variants that develop, he said.

Codagenix's manufacturing partner is Serum Institute of India Pvt. Ltd., the world's largest vaccine manufacturer by number of doses sold. Coleman said the Serum Institute has the capacity to manufacture 500 million doses per year or more of CoviLiv.

Also in the development pipeline of Codagenix is a vaccine for respiratory syncytial virus (RSV), which has drawn headlines locally and around the country in recent weeks as distressed babies and toddlers crowd pediatricians' offices and hospital wards. 

In June, Codagenix announced that it had received Food and Drug Administration clearance on an investigational new drug application to launch a phase 1 vaccine trial for infants and toddlers aged 6 months to 5 years. The intranasal vaccine, CodaVax-RSV, previously had been tested in a phase 1 trial on adults, aged 55 to 75.

"It's a peculiar virus," Coleman said. "Those who get really sick are kids … zero to 2 [years] and then [adults] over 65."

Nearly all children become infected with RSV by age 2 in the United States, with about 58,000 children under 5 needing hospitalization each year, according to the Centers for Disease Control.

"It's actually a really big global health burden," Coleman said. "It's not just here in the states."

By Ken Schachter

kenneth.schachter@newsday.comkschach

Ken Schachter covers corporate news, including technology and aerospace, and other business topics for Newsday. He has also worked at The Miami Herald and The Jerusalem Post.