USF Part Of Clinical Study Of Moderna Vaccine For Children

TAMPA, FL — As a record number of children are admitted to Florida hospitals with COVID-19, the University of South Florida Health Morsani College of Medicine will begin conducting a clinical study for a Moderna COVID-19 vaccine that could be given to children ages 6 months to 11 years old.

The delta variant has proven more contagious to children than the alpha variant of the coronavirus that swept the country last year. And, in some cases, it's proven more dangerous.

A South Florida teen, Paulina Velasquez, 15, is now recovering after being placed on a ventilator and then put in a medically induced coma after testing positive for COVID-19 July 11, according to CBSMiami.

On Aug. 6, Wolfson Children's Hospital in Jacksonville confirmed a 16-year-old patient had died from the coronavirus.

While the Centers for Disease Control and Prevention said the best protection against COVID-19 is a coronavirus vaccination, there currently is no approved vaccination for children under the age of 12. The Moderna vaccine is approved for ages 12 to 17.

As a result, instead of the handful of pediatric COVID-19 patients hospitalized in Florida a year ago, 135 pediatric patients are currently hospitalized in the state.

According to the Centers for Disease Control and Prevention, more than 45,000 children have been hospitalized with COVID-19 in the past year.

The CDC data tracker indicates an average of 192 children from age newborn to 17 years old are being admitted to hospitals for COVID-19 symptoms in the United States each day.

And unlike the alpha variant, it's not only children with immune disorders who are vulnerable to the respiratory disease.

The CDC said the delta variant is as contagious as chickenpox. In the past two months, the number of children testing positive for the delta variant rose sharply from 3 percent to more than 84 percent in the U.S., according to the American Academy of Pediatrics.

According to the Florida Department of Health, seven children age 15 and under died of COVID-19 in Florida between Jan. 1 and June 2. After June 2, the state announced it would no longer report COVID-19 statistics.

While CDC Director Dr. Rochelle Walensky said children are far less likely to die from the delta variant than adults, the numbers are nevertheless disconcerting.

According to the National Center for Health Statistics, 416 children age newborn to 18 years old have died in the United States for the virus.

“I think we fall into this flawed thinking of saying that only 400 of these 600,000 deaths from COVID-19 have been in children,” Walensky said. “Children are not supposed to die. And so 400 is a huge amount.”

Moderna intends to enroll up to 12,000 pediatric participants in the United States and Canada in its child vaccination research study, called the KidCOVE Study, which is taking place at 69 locations. In addition to USF, studies are occurring at the University of Florida in Jacksonville, Kissimmee Clinical Research, Prohealth Research Center in Doral and Allied Biomedical Research Institute in Miami.

Outside Florida, studies are being conducted in Virginia, Utah, Texas, Tennessee, South Carolina, Rhode Island, Pennsylvania, Oklahoma, North Carolina, New York, New Mexico, Nebraska, Missouri, Mississippi, Minnesota, Michigan, Maryland, Massachusetts, Louisiana, Kentucky, Kansas, Idaho, Georgia, Connecticut, California, Alabama and Arizona.

The completion date for the study is June 12, 2023.

USF Health research physicians are now seeking Tampa Bay area volunteers to participate.

“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 Dr. Charles Lockwood, 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.”

Leading the USF Health effort as principal investigator is 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.

“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,” 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.”

Participants will be seen by the study team based in USF Health’s Department of Pediatrics. Three out of four children participating in the KidCOVE clinical trial will receive two intramuscular injections of the vaccine spaced at four weeks apart.

The vaccine is made of messenger ribonucleic acid (mRNA), an instructional code that tells cells how to make protein, which help the body’s immune system make antibodies to fight the virus.

The remaining quarter of participants will receive injections of a placebo made of saline (sterile salt water) solution.

All participants will be randomly selected to receive the vaccine or placebo. Participants will be followed for 12 months post-vaccination to monitor their health and safety.

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 two weeks before vaccine administration
• Have participated in any clinical trial in the past month

Enrollment for the USF Health Moderna KidCOVE Study will get underway soon. Email usfchildrenscovidvaccine@gmail.com or phone 813-853-1149.

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