USF Health enrolling children ages six months to 11 years old in Moderna vaccine trial

Hillsborough County

TAMPA, Fla. (WFLA) — As children head back to school during Florida’s delta variant COVID-19 wave, many parents want to know when their children under 12 years old may be able to get vaccinated.

The USF Health Morsani College of Medicine announced Wednesday it has been selected to participate in the clinical trial testing the Modern covid-19 vaccine for children ages 6 months to less than 11 years old.

“USF Health is pleased to join this national clinical trial to determine the safety and effectiveness of Moderna vaccines in children and younger populations,” said Charles Lockwood, MD, senior vice president of USF Health and dean of the USF Health Morsani College of Medicine. “Widespread vaccination is the best defense against COVID-19, and this rigorous scientific study may go a long way toward increasing vaccine access in this younger demographic.”

Space is limited in this local trial in which three out of four children will receive two doses of the Moderna vaccine four weeks apart.

“I just want shots in arms as many as we can get,” Dr. Jennifer Jain from Tampa said.

Her two daughters turn two and four in October, so they are still not vaccine eligible.

“I literally jumped for joy when I heard about it,” Dr. Jain said of USF Health participating in the trial. “I had been in touch with the people in Jacksonville about their Moderna study.”

Before speaking with 8 On Your Side, she had already contacted USF Health.

“I am very eager to get my kids vaccinated,” Jain said. “COVID is a scary disease. As you know, numbers are through the roof, and many kids are getting ill, and yes it is true. Most kids do well, but not all of them.”

Dr. Carina Rodriguez, professor and chief of the Division of Pediatric Infectious Diseases in the Department of Pediatrics in the USF Health Morsani College of Medicine, will be the principal investigator for the USF Health trial.

“This research study can help provide critical information about the safety, reactogenicity and immune responses observed with the vaccine in children and ultimately allow the vaccine to be approved for children,” Dr. Rodriguez said. “A vaccine that prevents COVID-19 disease in children would be a crucial public health tool to help curb the pandemic. We are eager to contribute to the innovative science that is working to bring a safe and effective solution for our younger patients, who are also vulnerable to this health threat.”

Dr. Rodriguez told 8 On Your Side demand is high as many families have already expressed interest in enrolling their children.

“We want to make sure that it’s very representative of each particular ethnicity and race,” she said of enrolling a diverse group of children.

After Pfizer submits its vaccine safety data for review to the FDA by the end of September, children under 12 years old could start getting shots in arms this fall.

“I heard that might not be for the littlest kids,” Jain said. “It might be 5 through 11, so that’s why I’m considering enrolling my kids in this study. But the second my kids can get the vaccine they are there.”

Rodriguez explained the dosage amounts will be less for the toddlers than older children in the Moderna trial.

She would not specify exactly how many children will participate locally, but Moderna wants to enroll 12-thousand in the U.S. and Canada for the second phase of the trial called “KidCOVE Study.”

The participating children will be monitored for 12 months post-vaccination.

Eligibility criteria

Study volunteers must be:

  • Between 6 months and 11 years old
  • In good health or with stable chronic conditions

Study volunteers must not:

  • Have received an investigational or approved vaccine for COVID-19
  • Be currently taking any investigational or approved treatments for COVID-19
  • Have tested positive for COVID-19 or been in contact with anyone diagnosed with COVID-19 within 2 weeks prior to vaccine administration
  • Have participated in any clinical trial in the past month

Enrollment for the USF Health Moderna KidCOVE Study begins in coming days, via email (usfchildrenscovidvaccine@gmail.com) or phone/text (813-853-1149).

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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