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Long Island COVID-19 vaccine, testing companies look to market their products abroad 

Some countries won't receive vaccines in bulk until

Some countries won't receive vaccines in bulk until mid-2022 or 2023, said Mei Mei Hu, co-founder and chief executive of COVAXX. Credit: www.nbarrettphotography.com/Natalie Barrett

Long Island developers of vaccines, therapeutics and tests for COVID-19 are plowing ahead and looking to foreign markets as major pharmaceutical companies hold sway at home.

The Biden administration said it has ordered enough vaccine doses from Pfizer-BioNTech, Moderna and Johnson & Johnson to inoculate all U.S. adults by the end of May. Those companies also are working on booster shots should they be required for variants of the virus.

While the United States is hitting its stride — so far delivering at least one vaccine dose to about a quarter of the adult population, according to the Centers for Disease Control and Prevention — the rest of the world is lagging.

Even in the developed European Union countries, a median of only about 10% of those 18 and older have received one shot, according to the European Centre for Disease Prevention and Control. The EU has reported almost 600,000 cumulative deaths, surpassing the United States' total.

Adding to delays in global markets are several countries' suspension in rolling out the Oxford-AstraZeneca vaccine in response to reports of blood clots.

Some countries won't receive vaccines in bulk until mid-2022 or 2023, said Mei Mei Hu, co-founder and chief executive of COVAXX, which merged with another unit of Hauppauge-based United Biomedical Inc., to form Vaxxinity.

The World Health Organization's COVAX program (unrelated to COVAXX) for the developing world has reported shipping delays and has delivered only 30 million vaccine doses to 50 countries.

"Our job is to serve countries that are not at the front of the line," Hu said. "This isn't just a U.S. problem."

Here are updates on Long Island companies that continue to devise tools to battle the pandemic.

COVAXX:

The subsidiary of Vaxxinity has begun phase 2 trials on 3,100 patients for its UB-612 vaccine in Taiwan, where UBI maintains research and manufacturing facilities.

Phase 2/3 trials on the two-dose vaccine are planned for Taiwan, Brazil and India.

Taiwan and Aurobindo Pharma Limited, the East Windsor, New Jersey, unit of a pharmaceuticals company based in Hyderabad, India, are providing financial backing.

The deal with Aurobindo gives the company rights to make and market UB-612 for UNICEF, India and several other markets.

"We're targeting the developing world," Hu said.

The first 100 million doses of UB-612 are being manufactured in anticipation of regulatory approval, she said.

In January, COVAXX received emergency use authorization from the Food and Drug Administration for a COVID-19 antibody test manufactured at its Hauppauge facilities that can detect immune response to a vaccine or recent or prior infection.

Mutations in the virus that causes COVID-19 are expected to shape the market for vaccines.

"It will probably be like the flu where you'll get boosters," Hu said. "The booster is going to be a key to the game...We're not putting COVID back in the bag."

CODAGENIX INC.

Codagenix, a Farmingdale company that uses software to recode viruses, is aiming for a 2022 rollout of COVI-VAC, its COVID-19 vaccine candidate.

In January, the company launched phase 1 human trials of the vaccine in London and in March bolstered its management ranks, hiring a director of operations, an associate director of regulatory affairs and an associate director of clinical project management. Phase 2 trials are scheduled for the summer.

Like COVAXX, Codagenix has an India-based partner, the Serum Institute of India, which is providing financing and has agreed to produce 100 million doses of COVI-VAC.

Jeffrey Fu, chief business officer, said the pricing of COVI-VAC will be "extremely competitive" with other vaccines that will be available in lower-income countries.

Adding to the vaccine's appeal to global markets, Fu said, is that it requires only a single dose, is administered through the nose rather than an injection and can be preserved with standard refrigeration.

"I'd say it's possible that a Long Island company, Codagenix, could be the second-generation vaccine," said Leo Guthart of Roslyn-based TopSpin Partners, an early investor in Codagenix along with Accelerate Long Island and others.

Chembio Diagnostics Inc.

In June, the Food and Drug Administration, citing subpar performance, revoked the Hauppauge company's emergency use authorization to market its antibody test for COVID-19 domestically.

"While we have faced challenges on the regulatory front regarding our portfolio of COVID-19 tests, we remain committed to obtaining FDA approval for these tests," CEO Richard Eberly said in a statement this month. "We plan to build upon our the regulatory approvals received in other regions by driving international commercialization of our tests in their approved geographies."

Among the foreign markets cited by the company is Brazil, whose National Health Surveillance Agency has approved the antigen test system of a Chembio subsidiary.

Mirimus Inc.

The 11-year-old spinout from Cold Spring Harbor Laboratory began by developing genetically altered mice for use in research, including COVID-19 treatments.

Once the pandemic took hold, the Brooklyn company, led by Dr. Prem Premsrirut, who earned her doctorate in genetics at Stony Brook University, developed its SalivaClear testing method to cut costs and increase speed.

Earlier this month, SalivaClear earned the company $1 million as one of five winners of the XPRIZE Rapid COVID Testing competition.

The process collects saliva from groups of up to 24 people and tests the pooled saliva. When COVID-19 is detected in a pool, another round of testing is conducted on each two-person sample. If a two-person sample tests positive, tests are conducted on samples from individuals to identify the infected person.

The entire sequence is completed within 42 hours and avoids the expense of testing every sample.

CMTx Biotech Inc.

The Stony Brook startup has won a $315,000 grant from a unit of the National Institutes of Health for a phase 2 human clinical trial of its COVID-19 drug.

The orally administered drug candidate, incyclinide, has shown promise in early studies for reducing lung inflammation. Acute respiratory distress syndrome, a form of lung inflammation, is a complication that can be fatal for COVID-19 patients.

"There are no approved treatments for ARDS," said Joseph Scaduto, CEO and co-founder of CMTx Biotech. "We're trying to avoid ventilation and the intensive care unit."

Scaduto said the company is moving from Kings Park into the Long Island High Tech Incubator at Stony Brook University.

Applied DNA Sciences Inc.

Earlier this month, the Stony Brook company announced that it was beginning phase 1 of a clinical trial for a COVID-19 vaccine candidate for cats.

The trial, with Rome-based partner Evvivax SRL, uses a vaccine candidate originally developed for humans by Applied DNA and Evvivax parent Takis Biotech.

Applied DNA also said it had received an order for 10,000 COVID-19 test kits marketed under the FDA's emergency use authorization from an undisclosed customer.

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