LI's Codagenix, Covaxx advance COVID vaccines

Two Long Island developers of COVID-19 vaccines are pursuing human trials and developing distribution plans, part of a global effort that one logistics official called humanity's biggest product launch ever.

Partners of Hauppauge-based Covaxx and Farmingdale-based Codagenix Inc., already have begun production of the vaccine candidates in the expectation of successful human trials.

Covaxx, a spinout of United Biomedical Inc., has begun manufacturing its lead vaccine candidate, UB-612, in Taiwan, where the company has enrolled 60 patients in phase 1 clinical trials, said co-founder and co-chief executive Mei Mei Hu.

Further trials are planned for Nebraska and Brazil pending regulatory approval.

Should the vaccine candidate prove to be safe and effective, initial distribution would be aimed at developing countries in Latin America, Africa and the Far East.

"It's an emerging markets strategy," Hu said. "We've been negotiating supply agreements. We've allocated over 100 million doses with various emerging markets."

As of Nov. 3, the World Health Organization listed 47 vaccines in clinical trials and 155 in preclinical development.

"There's going to be such a dynamic landscape with multiple vaccines," Hu said. "We're already thinking about the logistics [of] how to deliver."

Covaxx has partnered with Danish shipping giant A.P. Møller-Mærsk to ship its vaccine pending approval by regulators.

The two-dose vaccine requires refrigeration at 2-8 degrees Celsius, standard refrigeration levels.

That compares to minus-75 degrees Celsius required by the two-dose vaccine candidate produced by Pfizer Inc. and its German partner Biopharmaceutical New Technologies, known as BioNTech. On Monday, Pfizer announced that its lead vaccine candidate had proven more than 90% effective in preventing COVID-19 in advanced clinical trials.

Robin Townley, head of special projects for A.P. Møller-Mærsk, said the distribution of vaccines is complex with regulatory, political and logistical dimensions.

The vaccine race does not end when a product is approved by regulators, he said, but "at the tip of the needle" when it is injected.

Townley said back-of-the-napkin math suggests that 10 billion doses of the first generation of vaccines will be required over two years.

"It will be the largest product launch in the history of the human race," he said.

Codagenix partner Serum Institute of India Pvt. Ltd. has begun producing its vaccine candidate, named COVI-VAC, even before the launch of its phase 1 trials in the United Kingdom.

Preclinical testing of a single dose administered through the nose via a dropper has produced positive results in animals, said Codagenix chief executive J. Robert Coleman.

Most vaccine candidates currently in development require two doses via injections separated by several weeks.

Coleman said Serum Institute of India is considering a variety of formulations, including one in which the vaccine could be stored as a powder at room temperature.

He said that the Codagenix vaccine could find favor in the pediatric market because no injection is required.

The company expects to hold phase 2 and 3 trials in India early next year.

Phase 1 trials typically gauge the safety of a drug that is tested on fewer than 100 healthy testers. In phase 2, the company tries to gauge the proper dosage based on results in a test often involving a few hundred people. In phase 3, involving hundreds or thousands of participants, the developer seeks to show the drug has a demonstable benefit.

Coleman said the company is in talks to distribute the vaccine in India and other developing countries as well as within the United States. He said 100 million doses or more could be produced by the second or third quarter of 2021.

A third Long Island company, Stony Brook-based Applied DNA Sciences Inc., which developed a COVID-19 candidate for humans with Rome-based Takiis Biotech, has redirected that vaccine toward the veterinary market.

A trial in cats will be conducted in upstate Brewster by Applied DNA and Takis animal health spinout Evvivax. Data from that trial could be applied in future trials, officials said.

The initial distribution and allocation of COVID-19 vaccines in the United States are expected to be overseen by federal authorities, but Melville-based medical and dental distributor Henry Schein Inc. said it could have a role once commercial distribution gears up.

"We have a well-established history of participating in public-private partnerships that address complex health care safety issues," the company said in a statement.

Correction: The name of the vaccine candidate that Codagenix partner Serum Institute of India Pvt. Ltd. has begun producing is named COVI-VAC. Due to incorrect information provided to Newsday, the name was incorrect in an earlier version of the story.

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.