Skip to content

SUBSCRIBER ONLY

What’s taking so long? Parents enroll their kids in COVID vaccine trials to help speed approval

AuthorLois K. Solomon, reporter for the South Florida Sun Sentinel
PUBLISHED: | UPDATED:

Kids’ COVID vaccines are coming. But not quickly enough for many parents.

Some, anxious about a new school year amid a surge of the delta variant, are asking for COVID shots for their young children, even though the vaccines are not approved yet for anyone under 12. The Food and Drug Administration warned nervous parents on Tuesday that they must wait patiently for the coming vaccines, promising “not to cut any corners.”

Other moms and dads are enrolling their youngsters in vaccine trials, hoping to speed the process toward the FDA’s blessing.

“We were hoping kids would be approved by now,” said Dr. Joanna Drowos, a Florida Atlantic University medical school professor who enrolled her two children in a Pfizer trial recently.

Her children, Lila, 11, and Jackson, 9, signed kid consent forms and had their blood drawn to test for antibodies. Each got a Pfizer shot, although they don’t know if they got the real thing or a placebo. Their parents are monitoring their symptoms and will return them for a second shot in three weeks.

“I was kind of nervous but it didn’t hurt that much,” Lila said. “It’s really cool to be able to do something that will help kids get the vaccine.”

Federal health officials say a vaccine for 5- to 11-year-olds could be ready by the end of the year. The only shot available for kids 12 and older is the Pfizer vaccine, which the FDA authorized in May. Moderna reported in July that it is working toward approval by the end of this year or early next year.

Parents who want their kids to participate in a trial in Florida have several options. Although the study the Drowos family is participating in does not need more volunteers, there are ongoing Moderna trials for ages 6 months to 11 at several sites around the state, including Miami, Tampa and Jacksonville. The study, which is expected to have 6,975 volunteers, will last 14 months and includes phone calls, telemedicine visits, and up to seven visits to the study site. To enroll, go to www.kidcovestudy.com.

Many parents are panicking as thousands of South Florida students and teachers have been exposed to COVID and have faced quarantine. Some kids with the virus have no symptoms; most others weather mild effects, such as fever, fatigue and cough. According to the American Academy of Pediatrics, there were 376,669 cases of kids with COVID in Florida as of Sept. 9, or 11.4% of cases.

A minority has suffered severe complications. Thirteen children in Florida have died out of more than 46,000 total COVID deaths, marking .03% of cases.

Dr. Scott Gottlieb, former FDA commissioner who now serves on Pfizer’s board of directors, is optimistic about coming approval for a vaccine for kids ages 5 to 11. In an interview last week with “Face the Nation,” he predicted authorization for emergency use of Pfizer’s kids’ vaccine by the end of October.

Many wonder about the delay, considering an adult vaccine became available about nine months after the pandemic hit the U.S. But health officials say children may require different doses from adults, possibly with only one jab needed.

Dr. Chad Sanborn, an infectious disease specialist at KIDZ Medical Services, which has offices throughout South Florida, said vaccine makers examine the assortment of reactions within each year of the 5-11 age group and will not treat the entire group as one.

“The dosing for an under 5-year-old may be different from a 13-year-old,” Sanborn said. “Additionally, we need to be sure that a COVID vaccine does not interfere with immunity from routine childhood vaccines and vice versa.”

Although some vaccine trials in past years have had difficulties recruiting participants, COVID vaccine volunteers, including kids, have not been hard to find, said Howard Schwartz, director of Research Centers of America, which has a clinic in Hollywood. His company conducted Moderna and Pfizer trials recently for 12 to 17 year olds.

“We had several thousand in the adult trials,” Schwartz said, and about 100 in the kids’ trials. “People were enthusiastic about volunteering.”

He said both parents and kids need to consent by signing detailed paperwork. They are not told whether they are getting a real dose of vaccine or a placebo. The kids have their blood tested before their first shot and have more blood drawn to test for antibodies after their second. Parents have to monitor the children for vaccine reactions, including fever, headache and arm soreness.

Dr. Hila Beckerman, a Delray Beach pediatrician, recently enrolled her son, Liam, 9, a fourth grader, in a Pfizer trial in Miami. She wanted him to get a real dose of vaccine but fears he got a placebo.

Liam Beckerman, 9, of Delray Beach, shows off his bandage after getting his first Pfizer shot as part of a COVID-19 vaccine trial for kids in Miami.
Liam Beckerman, 9, of Delray Beach, shows off his bandage after getting his first Pfizer shot as part of a COVID-19 vaccine trial for kids in Miami.

“I was hoping he would get a fever,” but he didn’t, which may show he was part of the control group, or he may have gotten a very low dose of vaccine, she said.

Liam said the worst part of the experience was the blood draw to check if he had COVID antibodies.

“It felt like it took forever,” he said. “One day I’ll see if it was worth it.”

His mom says she remains patient about a kids’ vaccine because she wants assurance that it has been thoroughly researched.

“It’s not something you want to rush,” Beckerman said. “You want parents to have full confidence.”