A child's journey: COVID-19 vaccine trials
WEST PALM BEACH, Fla. — In a matter of weeks, the U.S. Food and Drug Administration could grant emergency use approval for a COVID-19 vaccine for children under 12.
The FDA is moving forward with setting an advisory committee meeting for Oct. 26, and that's when the general public could learn more about forward movement in COVID-19 vaccine availability and approval for the younger age group.
Currently, about 4,000 families in West Palm Beach and surrounding areas are allowing their healthy children to participate in Pfizer's clinical trials of the vaccine for younger children.
Acevedo Clinical Research in Miami is heading up those trials. CBS12 News asked trial manager Martha Falcon if there are any glaring misconceptions about trials of this nature.
"There's a misconception that there's not a lot of data behind the clinical trials," Falcon said. "Sometimes, people don't understand that there are people monitoring these data points around the clock, and there's an electronic diary, for example, where parents can report the symptoms that the children are experiencing. Falcon said she's not permitted to talk about any severe reactions experienced by children so far during this particular study, and that only Pfizer currently holds that information.
Aspen, a Kindergartener in Palm Beach Gardens, is one of the thousands of families participating in the clinical trials. The 5-year-old loves to swim, ride his bike and climb trees - everything kids his age typically enjoy with their friends, but Aspen is growing up in anything but typical times during a pandemic. That's a big part of the reason his parents told CBS12 News they enrolled him in the trials.
"I thought what a wonderful way to be part of a solution for our community," Aspen's mother, Channing, said.
Aspen's father is a doctor, and he told CBS12 News that the decision to enroll was Aspen's, too.
"The idea of giving your child a shot that's brand new is scary for anyone," Aspen's father, Jeff, said.
For weeks, the family talked frankly with Aspen about risks and benefits and the most likely things that could happen.
"He could have a fever. He could have chest pains. He could feel really sick. He could have nausea," Jeff said. "I do recall him vividly saying - 'I could get really sick.' He repeated it back to me. He paused and thought it through, and then in his usual bubbly self, he went back to his bubbly self and said - what else?"
Once they'd made the decision to enroll Aspen, Jeff and Channing said they were surprised to learn how tough it was to actually get him in. Interest is high. Falcon said they had three times the inquiries about enrollment than expected, and it really spiked as kids got ready to head back to school in August.
Aspen got his fist shot, about 1/3 of the dose of what an adult would get of the Pfizer COVID-19 vaccine, on Aug. 30.
"He was doing jumping jacks in the waiting room because he was so excited about it," Channing said.
Channing said Aspen had a sore arm and complained of being tired, but that was it for symptoms. Aspen got the second dose about three weeks later. Jeff and Channing said the side effects were about the same, which makes them believe Aspen got the active vaccine and not a placebo. "We're so glad he's thriving," Channing said.
CBS12 News This Morning Anchor Ashley Glass has spoken with Aspen's family throughout this journey, and Aspen's responses have varied - some what you might expect from a child his age, while others surprised even his mom and dad.
"Being a part of science is cool and fun," Aspen said. "I just like wanted to do it so I could be safe and help the world."
Aspen said the first thing he wants to do when the pandemic is over is golf with his friends.
The family records everything through an app, and they'll record their journey for at least a year.
Once Pfizer imposes an unblinding of the study, Aspen will get confirmation if he received the active vaccine or a placebo. Falcon said all children in the trial will be offered the vaccine once the study is unblinded.