LAKELAND, Fla. (WFLA) – A Maryland-based vaccine development company has expanded its clinical COVID-19 vaccine trial to teenagers in Lakeland.
Novavax, which still awaits emergency use authorization for its two-dose COVID-19 vaccine from the U.S. Food and Drug Administration, is in phase 3 of its clinical trials.
It received $1.6 billion from Operation Warp Speed in July 2020 for coronavirus vaccine development.
It uses Accel Research Sites in Lakeland, formerly Meridian Research, to conduct some of its trials.
“This will determine the efficacy. This is how well does it actually work in real life and real time?” said Dr. James L. Andersen, principal investigator at Accel Research Sites in Lakeland.
One hundred and sixty four adults participated in the Lakeland-based clinical trial, with 90% of them still remaining in the trial, according to Dr. Andersen.
Now, that group has expanded to 12-17 year olds. Parental consent is required.
“This will also help with school enrollments, decreased propagation to adults and so forth,” said Dr. Andersen.
Participants are monitored for two years and paid $150 each for four total doses, and are reimbursed for follow-up appointments, according to Dr. Andersen.
Two-thirds of the participants receive the vaccine, while the rest get placebos. Months later, they switch.
“Everybody who got the active vaccine will get a placebo and everybody who got a placebo will get a vaccine so eventually everybody will be vaccinated,” said Dr. Andersen.
Novavax reports a 89.3% efficacy rate from its U.K. phase 3 clinical trials.
Dr. Andersen’s message to weary parents – these vaccines have already been tested.
“Phase three trials, there are no guinea pigs. Guinea pigs are long before this. There are animal studies first, then phase one studies that are human volunteers,” said Dr. Andersen.
Moderna, Pfizer and Johnson & Johnson are also conducting trials involving children.
Moderna’s trials include children as young as 6 months old.
Lakeland’s teen Novavax trial requires roughly 30 teenagers and will begin administering shots next week.
To learn more visit the clinical trials website.