Getting kids to participate in COVID-19 vaccine trials: The difficulties explained

RARE IN KIDS, AND THE MAJORITY OF THEM ABLE TO BEAT THE VIRUS. MANY PHYSICIANS STILL WANT THEM TO BE PART OF NEW CLINICAL TRIALS. THAT PROCESS GOING LESS SMOOTHLY THAN RESEARCHERS WOULD LIKE. IT IS A REAL CHALLENGE. IT HAS BEEN FOUR WEEKS. WE ONLY RECRUITED ABOUT 800 SUBJECTS IN THE TRIAL. HELENA: THAT COMPARED TO 800 SUBJECTS PER DAY FOR COVID VACCINE TRIALS FOR ADULTS. ACCORDIN TO THE CHIEF SCIENTIST OF OPERATION WARP SPEED. >> WE CAN’T HAVE THAT INDICATION UNLESS ADOLESCENTS AGED 12 TO 18 DECIDE TO PARTICIPATE AS A VOLUNTARY DECISION. HELENA: A HIGH SCHOOL SOPHOMORE WAS RECENTLY IN THE ICU SUFFERING COMPLICATIONS FROM COVID-19. WE HAVE SEEN KIDS GET VERY SICK AND EVEN DIE. THAT IS ON AN INDIVIDUAL FAMILY DOES ASIDE WHETHER THEY WAY OR RISK -- TO DECIDE WHETHER THEY WAY OR RISK THE BENEFITS. HELENA: THE DIRECTOR OF OPERATIONS UNDERSTANDS WHY THERE IS SOME DIFFICULTY GETTING KIDS ENROLLED IN THE TRIALS. FOR ONE, HE SAYS CHILDREN CAN’T GIVE CONSENT THEMSELVES TO PARTICIPATE SO BOTH PARENT AND CHILD HAVE TO BE ON BOARD. PERCY ADDS THAT SAFETY IS TH PRIORITY IN ANY CLINICAL TRIAL, BUT EVEN MORESO FOR KIDS. NOT TO MENTION >> NORMALLY WE WOULD WAIT UNTIL WE HAD A FULL SAFETY PROFILE FOR A VACCINE BEFORE WE ADMINISTERED IT TO KIDS. THAT MEANS YOU’D WAIT UNTIL A THE ADULT TRIALS WERE COMPLETELY FINISHED. SO THESE TRIALS WE’RE IN NOW ARE GOING TO BE TWO YEARS, POSSIBLY LONGER. HELENA: HE SAYS TRIALS MAY START OVERLAPPING NOW IN ORDER TO GET THE VACCINE INTO MORE PEOPLE, MORE QUICKLY. PFIZER AND MODERNA HAVE ALREADY STARTED PEDIATRIC TRIALS PERCY EXPECTS MORE OF THEM TO RAMP U AS WE GET FURTHER INTO THIS YEAR. PERCY ALSO MENTIONED THAT PEDIATRIC TRIALS HAPPEN ALL THE TIME BECAUSE WE HAVE TO KNOW WHAT MEDICATIONS A SAFE FOR CHILDREN. HE SAYS IF YOU HAV ANY QUESTIONS ABOUT ENROLLING YOUR KID IN ANY CLINICAL TRIAL, IT IS BEST TO SPEAK TO YOUR DOCTOR.

Although severe side effects are rare in kids, and the majority of them are able to beat the virus, many physicians still want them to be part of new clinical trials.That process is going less smoothly than researchers would like."It's a real challenge," said Moncef Slaoui, chief scientist with Operation Warp Speed. "It has been four weeks ongoing, we only recruited about 800 subjects in the trial."That, compared to recruiting 800 subjects per day for COVID-19 vaccine trials involving adults, according to Slaoui."We can't have that indication unless adolescents ages 12 to 18 decide to participate, of course, as a voluntary decision," Slaoui said. "We've seen kids get very sick and even die from it, so that's on an individual family to decide where they weigh the risk and benefits of participating in a trial versus not," Sterling Research Group Director of Operations Kurt Percy said.Percy said he understands why there's some difficulty in getting kids enrolled in the trials.For one, he says children can't give consent themselves to participate, so both parent and child have to be on board.Percy adds that safety is the priority in any clinical trial, but even more so for kids. "Normally we would wait until we had a full safety profile for a vaccine before we administered it to kids, that means you'd wait until all the adult trials were completely finished, so these trials we're in now are going to be two years, possibly longer," Percy said.He said trials may start overlapping now in order to get the vaccine into more people, more quickly.Pfizer and Moderna have already started pediatric trials. Percy expects more of them to ramp up as we get further into this year.

Although severe side effects are rare in kids, and the majority of them are able to beat the virus, many physicians still want them to be part of new clinical trials.

That process is going less smoothly than researchers would like.

"It's a real challenge," said Moncef Slaoui, chief scientist with Operation Warp Speed. "It has been four weeks ongoing, we only recruited about 800 subjects in the trial."

That, compared to recruiting 800 subjects per day for COVID-19 vaccine trials involving adults, according to Slaoui.

"We can't have that indication unless adolescents ages 12 to 18 decide to participate, of course, as a voluntary decision," Slaoui said.

"We've seen kids get very sick and even die from it, so that's on an individual family to decide where they weigh the risk and benefits of participating in a trial versus not," Sterling Research Group Director of Operations Kurt Percy said.

Percy said he understands why there's some difficulty in getting kids enrolled in the trials.

For one, he says children can't give consent themselves to participate, so both parent and child have to be on board.

Percy adds that safety is the priority in any clinical trial, but even more so for kids.

"Normally we would wait until we had a full safety profile for a vaccine before we administered it to kids, that means you'd wait until all the adult trials were completely finished, so these trials we're in now are going to be two years, possibly longer," Percy said.

He said trials may start overlapping now in order to get the vaccine into more people, more quickly.

Pfizer and Moderna have already started pediatric trials. Percy expects more of them to ramp up as we get further into this year.

Getting kids to participate in COVID-19 vaccine trials: The difficulties explained

TRACKING THE COVID-19 VACCINE