More COVID-19 Vaccine Work Coming To Wilmington Health

By Christina Haley O'Neal, posted Dec 2, 2020
Wilmington Health Research has been awarded additional clinical trials related to COVID-19, practice officials said Wednesday.

"We are likely to be starting two additional vaccine trials," Brian Webster, a physician and chief medical information officer at Wilmington Health, said in an email. "These vaccine candidates are a different formulation and mechanism of action than the Pfizer and Moderna vaccines seeking FDA approval.

"If successful, this will give us multiple prevention options. We need to have many manufacturers to provide vaccines worldwide quickly," he added.

Pfizer Inc. and its partner in the vaccine, BioNTech SE, announced that the Medicines and Healthcare Products Regulatory Agency in the United Kingdom on Wednesday granted a temporary authorization for emergency use of Pfizer/BioNTech's COVID-19 mRNA vaccine -- the first such approval of a vaccine against COVID-19 in the world.

The companies await further regulatory authorizations or approvals in the coming days and weeks worldwide, including in the U.S., where approval will be mulled over by FDA regulators still reviewing emergency use requests from Pfizer and Moderna on the use of their vaccines.

Wilmington Health Research has already played a role in COVID-19 vaccine trials for Pfizer's candidate.

There were 600 patients enrolled in trials for Pfizer's vaccine from August through October, said Kevin Cannon, a Wilmington Health Research physician. The work was in partnership with PMG Research of Wilmington, part of the PMG network of clinical research sites.

"The maintenance phase of the study is ongoing, and we are very proud of the work that has been done. We still have much work to demonstrate safety and effectiveness, but preliminary data is obviously better than we could have hoped for," Cannon said in an email. 

"Lastly, an eternal debt of gratitude should go out to our local volunteers. Nothing was guaranteed when we embarked on this journey and they put their trust in us and that has made this possible," he added.

In addition, Wilmington Health has clinical trials, both ongoing and soon to start, for the outpatient treatment of COVID-19, Webster said. 

Wilmington Health Research continues to enroll in the "Regeneron monoclonal antibody COVID treatment trial," Cannon said. 

"We have enrolled over 200 patients from the community and continue these efforts," Cannon said. "We are optimistic that the data will demonstrate an excellent treatment option for those that test positive and are symptomatic.”

Another option that is being considered is a remote trial, Webster said, adding that "Nurse visits will be done at the patient’s home, avoiding bringing sick or infectious patients to the clinic." 

"We are also involved in a prevention trial for frontline workers. We will be recruiting for patients who are exposed to known cases of Covid-19 in their work environment. The concept is that the study drug will potentially prevent infection or at least lessen severity of infection," Webster said.

The research by Wilmington Health physicians adds to a growing list of COVID-19 vaccine and treatment work happening in the area.

"North Carolina companies have played a major role in advancing treatments, vaccines and testing for the pandemic, and companies in our local clinical research industry cluster have played and will continue to play a critical role in overcoming the COVID-19 pandemic," said Randall Johnson, executive director of the N.C. Biotechnology Center's Southeastern Office.

Work on both the Pfizer and Moderna vaccine candidates has taken place in the Wilmington area.

Wilmington-headquartered PPD Inc. has worked heavily with Moderna on its vaccine, as well as on COVID-19 treatments.

"PPD‘s work with Gilead to advance the Remdesivir treatment is just one example of the way our local clinical research industry cluster in the Wilmington area is creating a favorable impact on our battle against COVID-19," Johnson said. "We are fortunate here in the southeastern region to have a wealth of companies and talented professionals on the front lines of the global battle against COVID-19."

On top of PPD's work, Wilmington-based Trial Management Associates (TMA), a clinical research management firm, has conducted clinical trials for the Moderna vaccine candidate.

Last week, TMA announced more COVID-19 vaccine work, stating that two different companies, each with their own new vaccine, have selected the firm to conduct clinical trials with physicians Bart Williams and Will Jones of Wrightsville Family Practice. 

The names of the two firms bringing the new vaccination trials to Wilmington have not been disclosed by TMA, which is citing confidentiality reasons. Those trails are likely to start this month and do not involve Moderna or Pfizer, officials said.

Johnson said the area's clinical cluster will continue to have more influence and impact in the fight against COVID, especially as more clinical trials move forward for treatments and for vaccines around the country.

"We're actually pretty well-positioned to be part of the effort," he said. "And the state is well-positioned to be part of that effort, both from a manufacturing standpoint and a clinical trial standpoint."
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