Atrium opens new COVID-19 vaccine trial for children ages 12 to 17

Atrium Health is launching a new COVID-19 vaccine trial for children and teens, the hospital has announced.

The trial began Thursday and will run through May 21. The trial is for the Novavax COVID-19 vaccine, which is a protein-based vaccine, according to Atrium.

Atrium’s Levine Children’s hospital was selected by Novavax and the National Institutes of Health (NIH) as a site for the the COVID-19 vaccine adolescent trial.

To be eligible to take part in the trial, children must be between the ages of 12 and 17, have not contracted the virus nor have any medical conditions that affect their immune system and are not currently being treated for cancer.

“It’s so important for us to understand the way these vaccines work in children so that we can make recommendations safely and confidently,” said Christine Turley, MD, vice chair of research at Levine Children’s and lead physician investigator of the STRIVE program. “Just like adults, children want to move forward and engage in everyday activities again. Many want to be part of finding answers to the vaccine-related questions we are facing every day.”

The announcement of the new vaccine trial comes as the Food and Drug Administration is planning to authorize use of the Pfizer vaccine in young children ages 12 to 15. Atrium said it’s prepared to distribute the vaccine to adolescents as soon as FDA grants the official approval.

More than 3.3 million North Carolinians — more than 50 percent of the population — have already been at least partially vaccinated with either the Pfizer, Moderna or Johnson & Johnson vaccines, including almost 16,000 people in Stanly County, according to state data.

Researchers in the U.S. have been actively studying the Novavax vaccine in adults since last summer, according to Atrium, and the vaccine has also been tested on adults in the U.K. with a roughly 90 percent efficacy rate.

The trial will follow participants for about two years. The study involves several visits over the first six weeks, and another series of visits after six months. The study will include seven blood tests and two nose swabs for COVID-19.

Side effects for the vaccine, like many of the others, may include include headache, fever, body aches, fatigue, arm pain and redness at the injection site.

Atrium will stay in close contact with families throughout the study. This will include weekly follow-up calls for the first year as well as office visits as needed for any concerns about the vaccine or side effects.

Parents or legal guardians can sign up for their teen to be considered for the study using the STRIVE Vaccine Research Registry.

There is no cost to take part in the study and NIH will give a stipend for participants and families to help cover the time and effort required for the study, Atrium said.