Teen Volunteers Sought For Covid Pediatric Vaccine Study In Lakeland
A clinical trial for COVID -19 vaccines in children will kickoff in Lakeland next month.
Accel Research Sites is seeking volunteers between ages of 12 and 17 to take part in a study of Novavax Inc.’s coronavirus vaccine starting May 3. Dr. James Andersen, Accel’s principal investigator in Lakeland, said it will be one of about 80 to 90 sites participating in the national study.
“Realistically, we are all set up and ready to go,” he said. “Everything is essentially the same as the adults.”
Novavax, a Maryland-based biotechnological company, has created a COVID-19 vaccine that is entirely synthetic and designed with a unique protein cap to help it better penetrate into a person’s blood stream, according to Andersen. The vaccine also seeks to causing less unwanted side effects.
“There’s nothing infectious in it, so you cannot catch anything from it,” he said.
Similar to Pfizer’s, the vaccine consists a two-short series that requires an initial dose followed by a booster 21 days later. The study will use what’s called a 2:1 ratio, according to Anderson. In other words, there will be two volunteers who will receive the vaccine to every one who gets a saline water injection as placebo.
Novavax is currently wrapping up adult clinical studies of its vaccine, which includes 146 volunteers in Lakeland. It is expected to release the study results and seek emergency use authorization from the U.S. Food and Drug Administration in late April or early May, according to USA Today reports.
Teens who take part must agree to be medically followed for two years after receiving the vaccine. Anderson said this will include follow-up medical visits and repeat blood tests.
“Everyone needs to know how long these vaccines last,” he said. “Without following up with specific testing, there’s no way to know.”
Anderson said while there’s a lot of buzz about COVID antibodies, the rapid tests only reveal whether a person has them or not. It does not indicate what level of antibodies or protection a particular individual possesses, according to Anderson.
One challenge facing the Accel Research study is recruiting teenage volunteers and obtaining medical consent. Any person age 12 to 17 who is interested must also have their parent or legal guardians permission to take part.
Volunteers will be monetarily compensated for their “time and trouble,” according to Anderson, but the exact amount or rate has not been finalized.
