NORWOOD, Ohio (FOX19) - Johnson & Johnson’s single-dose COVID-19 vaccine, which is being studied at the CTI Research Study Center in Norwood, is showing promise.
Early trials for the vaccine have proven to be effective with the initial two phases producing a strong immune response, according to CTI CEO Tim Schroeder.
“The single-dose gave you 90 percent efficacy in all age groups and all risk factors and the side effect profile generally very mild across all the individuals,” Schroeder said.
Once data from the phase three trial becomes available and the vaccine proves to work and is safe, Johnson & Johnson will request an emergency use authorization from the FDA.
“I think there’s a particularly high-level interest now because we’ve finished the enrollment of the phase three study,” Schroeder explained. “Which is the pivotal study for the approval, not just here in the U.S., but all over the world.”
Getting to the final phase of Johnson & Johnson’s trial has taken longer than the Pfizer and Moderna vaccines, but Schroeder says that’s not necessarily a bad thing.
“That cold storage of that minus 80 degrees causes some real logistic challenges, and the Johnson & Johnson one doesn’t require the minus 80 degrees and it’s a single dose,” Schroeder said. “So, in some ways, it offers the best of both worlds.”
The single-dose option from Johnson & Johnson could be a gamechanger in the fight against COVID-19, Schroeder believes.
He thinks Johnson & Johnson will release data from the final phase of the trial next week and make an FDA submission in February to get emergency approval for the vaccine in March.
CTI, according to Schroeder, was one of the top enrolling sites for Johnson & Johnson and its Janssen Pharmaceutical companies COVID-19 phase three trial.
“What the pharmaceutical companies have done is they have generally found one location in a city and focused all the resources there,” Schroeder said. “Cincinnati Children’s Hospital was the main focus for Pfizer. University of Cincinnati was the main focus for Moderna. And Johnson & Johnson has been the main focus for CTI.”
Schroeder says CTI is always looking for participants to help with current and future studies as well.
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