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Moderna COVID-19 vaccine study for children under 12 starting at UW Health
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UW HEALTH | COVID-19 RESEARCH

Moderna COVID-19 vaccine study for children under 12 starting at UW Health

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American Family Children's Hospital 

A clinical trial of Moderna’s COVID-19 vaccine in children under 12 will start enrolling participants at UW Health Friday, as researchers and regulators move closer to potentially authorizing shots for the only age group not yet eligible in the United States.

Pfizer says new data suggests a third dose of its COVID vaccine can strongly increase protection against the delta variant.

UW’s American Family Children’s Hospital is one of about 100 sites involved in the study, which aims to sign up about 12,000 children, said Dr. William Hartman, a UW Health anesthesiologist and co-leader of the study at UW, which likely will enroll roughly 80 children.

“The goal of the vaccine is to prevent COVID-19 from overwhelming the population again,” Hartman said. “A big part of that is going to be vaccinating our children since schools and school buses are some of the biggest areas of congregation of children, with the potential for spreading COVID.”

Three-fourths of participants will get two doses of the vaccine, four weeks apart, and one-fourth will get placebo shots. Children ages 6 to 12 will be inoculated first, followed by those ages 2 to 6 and then those 6 months to 2 years.

An earlier part of the study has been assessing three levels of doses in children — 100 micrograms, the dose now given to adults; 50 micrograms; and 25 micrograms. The broader Moderna study will use the 50 mcg dose for ages 6 to 12. The company has not said which dose will be given to younger children, Hartman said.

Rare cases of heart inflammation have been reported in some recipients of the Moderna and Pfizer COVID-19 vaccines, mostly in male adolescents and young adults, according to the Centers for Disease Control and Prevention.

“There’s a robust immune response that children can get,” Hartman said. “To try to counter that, they want to go with the lowest dose where they can get the maximum effect.”

For each child, the study lasts 14 months, including at least four follow-up visits. Participants can’t have COVID-19 or be exposed to someone with a coronavirus infection in the two weeks before getting their first shot, and those with chronic diseases such as asthma and diabetes must have the conditions under control.

Though COVID-19 is typically most serious in older adults, more than 4 million American children have contracted infections, according to the American Academy of Pediatrics, and about 350 have died, according to the CDC.

With the more contagious delta variant of the coronavirus causing a surge in COVID-19 infections in Wisconsin and around the U.S., a higher percentage of the population must be immunized to achieve herd immunity that can prevent outbreaks, Hartman said.

The Food and Drug Administration authorized the Moderna vaccine for adults 18 and older in December. Moderna applied for authorization for ages 12 to 17 in June, after releasing data in May that the company said showed the vaccine was safe and effective in that age group.

FDA authorization for Pfizer’s vaccine, issued for ages 16 and older in December, was expanded to ages 12 to 15 in May. It involves two injections given three weeks apart.

Pfizer has said it expects to have clinical trial results of its vaccine for ages 5 to 11 in September, with results for ages 2 to 5 soon after that, according to the New York Times. Results for 6 months to 2 years are expected in October or November.

Johnson & Johnson’s single-dose vaccine is authorized for ages 18 and older, with the company saying it will start a study in ages 12 to 17 this fall, The Hill reported in early July.

The only other COVID-19 vaccine trial held at UW Health involved AstraZeneca’s candidate, for which the company has said it will seek approval later this year. About 425 people participated in the study at UW last fall and early winter, Hartman said.


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