COVINGTON, Ky. — Kentucky continues to play a major role on the vaccine front.

What You Need To Know

  • Kentucky playing a role in the Johnson and Johnson vaccine

  • Covington-based CTI is part of the vaccine trials

  • Researchers in Kentucky are optimistic about the vaccine's success

  • CTI is looking for more people to participate in the trials

 

Last fall, we first told you about a Northern Kentucky research and clinical trial firm dosing its first patient. Covington-based CTI Clinical Trial and Consulting Services is part of a large-scale phase 3 trial of the Johnson and Johnson COVID-19 vaccine. 

“Across the U.S. at least, you know we’re going to have five vaccines which hopefully can get in the supply chain,” said Tim Schroeder, CEO and Chairman of CTI. 

Of the most talked about five vaccines (Pfizer BioNTech, Moderna, Johnson and Johnson, Novavax, and AstraZeneca) there is the Janssen Pharmaceuticals parent company Johnson and Johnson single-shot vaccine.

“We’re very optimistic that the Janssen one will get the Emergency Use Authorization, probably in the next 30 to 45 days,” Schroeder said.

Schroeder and his team which includes Dr. Antoinette Pragalos studied safety and efficacy data to demonstrate that the single-dose COVID-19 vaccine met all primary and key secondary endpoints.

“So the efficacy is what everyone is focusing on,” Pragalos said.

More than 43,700 participants took part in the global study with 500 people from the Cincinnati region. The study found 28 days after the vaccine, patients showed complete protection against COVID-related hospitalization or death.

“On average throughout globally, they came out at 66%, in the United States at 72% which is you know phenomenal and you know that’s efficacy for the vaccine,” Pragalos said.

While that number may seem lower than Pfizer-BioNTech and Moderna’s mid-90s efficacy rate, Pragalos said there are several factors to consider.

“So when you look at our study versus the original studies, not the original, the studies for Pfizer and Moderna, they were done at a time where COVID incidence was much much lower. Ok so they were given a vaccine, they go out into the public, there was much less seen by numbers globally,” Pragalos said.

Phase 3 of what’s called the ensemble study for Johnson and Johnson started in October.

“And then this upsurge started again and when Janssen, when we started up and especially when we were really, really busy with it the numbers were astronomically more,” Pragalos said.

For researchers, this is promising and hopefully adding another vaccine to the supply chain distribution.

“Any vaccine that you are offered, you should strongly consider taking it,” Schroeder said.

The research firm also announced they are recruiting people to take part in another two-shot COVID-19 vaccine trial for Johnson and Johnson. If you are interested you can sign up here. 

 

 

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