CT Parents Still Waiting For FDA Approval Of Vaccine For Children

CONNECTICUT — With the first day of school now less than a week away in most Connecticut towns, some parents are anxiously awaiting word when they can have their school-age children vaccinated against the coronavirus.

Pfizer’s vaccine is authorized for emergency use for children aged 12 and up and fully approved for those 16 and up. Moderna Inc.'s and Johnson & Johnson’s vaccines are authorized only for those 18 and over and aren’t fully approved.

There is still no vaccine available for children 11 and under, however. What's the hold up?

Dr. Colleen Kelley of Emory University told Atlanta station 11 Alive: "What we need to do for children is figure out what the right approach for them is. Their immune system works a little differently than adults. Their physiology is different, and so we need to figure out the right doses, intervals and right approach. That might be a little different than adults."

According to Connecticut Children’s Hospital's infectious disease expert Dr. John R. Schreiber, "Clinical trials don't just show whether a vaccine will be effective – they must also show that it will be safe." The FDA has requested four to six months worth of follow-up safety data for COVID-19 vaccine trials in children under age 12, according to Schreiber. By comparison, they only required two months of data for adult trials.

Both Pfizer and Moderna anticipate sharing their safety results in September or October, and could file for emergency use authorization after that, Schreiber said.

The age group accounts for nearly 460,000 children in Connecticut, and 48 million nationwide.