Long Island startup testing human COVID-19 vaccine

A small Long Island biotechnology startup in the global competition to develop the COVID-19 vaccine has developed a human testing program.

A Phase 1 trial using approximately 50 paid young adult volunteers will evaluate the safety of the Codagenix Inc. vaccine and will be conducted in London by the Dublin-based Open Orphan plc unit.

Codagenix Inc. vaccines are made from attenuated or attenuated versions of the whole virus, redesigned to reduce the ability of the virus to make copies of itself.

It is unlike almost all 169 other vaccine candidates cataloged by the World Health Organization.

According to the WHO, all but Codagenix and two other developers use dead viruses, some of the viral genetic material, or some of the viruses such as spike proteins.

Eleven Codagenix executives, affiliated with the vaccine manufacturing giant Serum Institute in India, hope their strategy will generate a stronger immune response to COVID-19.

Dr. Anthony Fauci, White House Coronavirus Advisor, warns that vaccines in development are unlikely to provide complete protection, and the Food and Drug Administration has approved vaccines that are safe and more than 50% effective. ..

According to the Johns Hopkins University dashboard, the coronavirus has infected more than 20 million people and killed more than 700,000 people worldwide.

Steffen Mueller, president and chief scientific officer of Codagenix based in Farmingdale’s Broad Hollow Bioscience Park, said the pilot study of vaccinating vaccinated hamsters is encouraging.

“They were all fine,” he said. “There was protection. It looks very promising.”

If the Phase 1 trial goes as planned, Muller said he might consider holding a Phase 2 or 3 “human challenge” trial in India.

In a typical human challenge test, healthy volunteers are inoculated, given time to develop an immune response, and infected with a pathogen, in this case COVID-19.

Adrian Wildfire, Director of Science and Business Strategy at Open Orphan, which specializes in human attack testing of vaccines and antivirals, said human attack studies required the time and number of volunteers to establish vaccine efficacy. Said that it can reduce.

Human trials are being used to develop new treatments for malaria, smallpox, and other diseases for which effective treatments already exist. Known treatments cannot stop COVID-19, and such trials are controversial.

“I’m very interested in human issues,” said Emily Lagent, who teaches medical ethics and health policy at the Perellman School of Medicine at the University of Pennsylvania.

She said decisions regarding the use of trials to challenge humans should be considered in the context of the value of speeding up marketing of vaccine candidates during a deadly pandemic.

“Probably not all risks can be ruled out,” she said.

Bettie Steinberg, a vaccination expert and spokesman for Feinstein Institutes for Medical Research at Northwell Health, said live virus vaccines, such as the vaccine being developed by Codagenix, work better than vaccines that use dead viruses. There are many.

“If you have a weakened virus that grows a little in a person, you get a better immune response,” she said.

She pointed to the first polio vaccine, a dead version of the virus later developed by Jonas Salk, which was later superseded by the live attenuated virus of Albert Sabin, often carried in sugar cubes. It was

According to Steinberg, Phase 1 trials focus on adjusting the appropriate dose of a drug or vaccine, while Phase 2 trials have traditionally targeted hundreds of volunteers, with some on efficacy. Are investigating safety in the long run while collecting data on Phase 3 studies usually use thousands of people, some vaccinated and some placebo Gain insights into long-term efficacy and safety, including critical responses.

As of August 10, the World Health Organization has registered 28 COVID-19 vaccine candidates in clinical trials. They included AstraZeneca and its partners Oxford and Pfizer and their partners, pharmaceutical giants like BioNTech and Chinese vaccines.

WHO also listed 139 vaccine candidates in preclinical evaluation, including vaccines from Codagenix and its partner Serum Institute in India.

Applied DNA Sciences Inc., based in Stony Brook, another long island company on WHO’s list of preclinical trials, is providing DNA technology as part of Rome-based Takis Biotech’s efforts.

The Indian Serology Institute is betting on the global vaccine competition.

The serum laboratory, owned by the billionaire Punawara family, has begun manufacturing candidate vaccines developed by AstraZeneca and the University of Oxford, which it has found safe and effective in ongoing trials, and has said Has been approved.

News of Codagenix’s planned Phase I trial is coming when reports from Russia and China suggest that vaccine candidates from those countries are nearing release.

Last month, Gao Fu, director of the Centers for Disease Control and Prevention in China, said he had been injected with an vaccine, and Russian President Vladimir Putin said Tuesday that the vaccine made by the Gamalehya Institute in Moscow would be the first regulatory agency in the world. He said he was approved.

Ken Schachter covers corporate news such as technology and aerospace, as well as other Newsday business topics. He also worked at the Miami Herald and Jerusalem Post.