UPMC enrolls children in Modernacovid vaccine trial

The UPMC Children’s Hospital in Pittsburgh is enrolling children in the covid-19 pediatric modelna vaccine trial.

Moderna is testing the safety and efficacy of the covid-19 vaccine in children aged 6 months to 12 years.

“Sure, vaccines have been found to be effective, safe and effective in adults, but we need to do the same clinical trials we did in adults in the pediatric age group,” said a pediatric professor. One Dr. Judy Martin said. A member of the University of Pittsburgh School of Medicine and the Pitt Vaccine Research Center.

She said that different age groups could have different responses to the vaccine.

The Moderna trial has multiple stages.

At this stage, which began in March, Martin said, the optimal dose for each age group needs to be determined.

At this stage of the study, participants may receive either of two dose levels (50 or 100 micrograms). Participants aged 6 months to 2 years can receive one of three dose levels: 25, 50, or 100 micrograms. Each child receives a second booster after the first 28 days.

This part of the study is “very complex”. “Start with the oldest child before moving to the younger age group and start with the lower dose before moving to the higher dose,” Martin said.

At the next stage, when researchers are currently recruiting children to join, they will compare vaccine doses to placebo. Children should be vaccinated twice every 28 days or saline placebo twice. One in four children will receive a placebo.

Children, parents, and pediatricians do not know if they have been vaccinated or placedbo. After the second vaccination, participants will undergo a 12-month follow-up to determine the effectiveness of the vaccine against covid-19.

The next phase of the trial, scheduled to begin in late July, will continue to focus on safety while also determining the efficacy of the vaccine in the younger age group, Martin said.

The University of Pittsburgh Vaccine Trial Unit is one of 100 US and Canadian research sites participating in a study aimed at enrolling 7,050 children. Participation period is about 14 months.

Moderna vaccine More than 90% effective in the adult population, And has already been given to an estimated 17.8 million adults in the United States.

May Moderna said the vaccine Seems to provide strong protection for children up to 12 years old.. The FDA has granted the vaccine produced by Pfizer Emergency Use Authorization for children up to 12 years..

Children are less likely to get serious illness than older adults, Some experts say vaccination of children is an important step Towards the end of the pandemic.

“Immune children can protect them as well as the adults around them who have not been vaccinated,” Martin said.

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

Martin said he would categorize the list of potential participants based on age group and start contacting participants after July 4.

She said the expert would be happy to answer questions from the parents of potential participants.

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

According to Martin, the safety protocol in pediatric studies is similar to that used in adult trials.

“It’s all the same safety measures and concerns we’re doing in any study. We’re looking for a very wide range of signs and symptoms because we don’t know what’s going to happen,” she said. Told. “Their safety is paramount.”

According to Moderna, study participants can withdraw from the study at any time for any reason, and research physicians will stop volunteering at any time for the safety of the participant or if the participant no longer meets the research requirements. can.

The results of this study are still months away, according to Martin.

According to Martin, the final stage of the trial will take months, and researchers will want to see safety data for at least two months.

Most children don’t seem to have access to the covid-19 vaccine for some time, but Martin said he feels optimistic.

“We certainly hope that children will get similar results based on the success of the mRNA vaccine in adults,” Martin said.