UPMC enrolling kids for Moderna covid vaccine trial

UPMC Children’s Hospital of Pittsburgh is enrolling children for a covid-19 pediatric Moderna vaccine trial.

Moderna is testing the safety and effectiveness of their covid-19 vaccine for children ages 6 months to 12 years old.

“Certainly, even though we know the vaccines are working in adults and they are safe and effective, we need to do the same clinical trials we did with adults in the pediatric age group,” said Dr. Judy Martin, a professor of pediatrics at the University of Pittsburgh School of Medicine and a member of Pitt’s Center for Vaccine Research.

Different age groups can respond to the vaccines differently, she said.

Moderna’s trial involves multiple phases.

The current phase, which began in March, involves determining the optimal dose for each age group, Martin said.

In this phase of the trial, participants may receive one of two dose levels — either 50 or 100 micrograms. Participants ages 6 months to 2 years may receive one of three dose levels — 25, 50 or 100 micrograms. Each child will receive a second booster dose 28 days after the first.

This part of the study is “very complicated,” Martin said, because “you start with the oldest children before you move to younger age groups, and you start with lower doses before you move to higher doses.”

In the next phase — which is what researchers are currently recruiting children to participate in — researchers compare a vaccine dose to a placebo. Children will be given either two doses of the vaccine or two doses of a saline placebo, with doses 28 days apart. One in every four children will receive a placebo.

The children, their parents and their pediatricians will not know whether they received the vaccine or the placebo. After the second vaccination, participants receive 12 months of follow-up to determine the vaccine’s effectiveness in protecting against covid-19.

The upcoming phase of the trial, which is slated to begin in late July, will continue focusing on safety, Martin said, while also working to determine the vaccine’s efficacy in younger age groups.

The University of Pittsburgh’s Pittsburgh Vaccine Trials Unit is one of 100 study sites in the United States and Canada participating in the study, which aims to enroll 7,050 children. Participation lasts about 14 months.

The Moderna vaccine is reported to be over 90% effective in adult populations, and has already been given to an estimated 17.8 million adults in the United States.

Moderna in May said its vaccine appears to offer strong protection for kids as young as 12. The FDA granted a vaccine produced by Pfizer emergency use authorization for children as young as 12.

Though children aren’t as susceptible to severe disease as older adults, some experts say vaccinating kids is an important step toward ending the pandemic.

“By immunizing children, we can help to protect not only the children themselves from getting covid, but also the adults around them who aren’t vaccinated” or those who may not have strong protection from vaccines because of immune system issues, Martin said.

Researchers are looking for healthy children to enroll in the trial, Martin said. Potential participants can register online at PVTU.org.

Martin said they’ll sort through the list of potential participants based on age groups, and begin reaching out to participants after July 4.

She said experts are happy to answer questions from potential participants’ parents.

“It’s an individual decision,” she said. “Everyone is going to have different concerns.”

Safety protocols in pediatric studies are similar to those used in adult trials, Martin said.

“It’s still all of the same safety measures and concerns that we do in any study. You never know what’s going to show up, so it’s a very broad range of signs and symptoms we’re looking for,” she said. “Their safety is of utmost importance.”

Study participants can drop out of the study at any time, for any reason, and study doctors can discontinue a volunteer’s participation at any time for the participant’s safety, or if the participant no longer meets study requirements, according to Moderna.

Results from the study are still months away, Martin said.

The final phase of the trial will take several months, Martin said, and researchers will want to see at least two months of safety data.

While it seems most children won’t have access to a covid-19 vaccine for a while, Martin said she’s feeling optimistic.

“We’re certainly hopeful based on the success of the mRNA vaccines in adults that we would have similar results for children,” Martin said.