Why is it taking so long to develop a COVID-19 vaccine for children?

There was a lot to go before. Containers holding shots from Pfizer Inc. and BioNTech SE got the vaccine to a pharmacy across town without getting too hot. Pharmacists working in a sterile room, free of contamination, are required to collect the shots in small doses safe enough for children. In the end, the vaccines had to be sent back to senders for injection into six-month-old babies.

A mistake could jeopardize the results of the study, render the vaccine ineffective, or delay testing.

“We do studies in kids all the time, and we’ve never had anything to do with so many steps,” said pediatrician Shelley Sanders. Counting to test Covid-19 shots in children.

The logistic dance required to make dosing safe for children is one of the challenges faced by researchers evaluating vaccines in youth.

Complicating the trials, the researchers said, federal health regulators demanded that more children be enrolled in the study than originally planned. Enrolling children takes longer than adults because it requires parental consent, and some youth don’t do volunteer work because they fall behind on needles. Then to assess whether the shots help, the researchers said, they must find out if a child gets sick, no easy task with young children who can’t always tell how they feel. are.

Challenges are contributing to the longer timeline for testing shots in children. The results of the Pfizer-BioNTech trial for children ages 5 to 12 are expected by the end of this month, which could mean the shots aren’t authorized for use until October or November, months after they are approved for teens. . Data for young children could come in October.

Moderna Inc. expects to seek emergency use for children ages 6 to 12 by the end of this year, and for children aged 6 months to less than 6 years early next year, a spokesperson for the company said. .

The timetable is frustrating some parents who are eager to get their kids vaccinated as the delta version spreads and a new school year begins. Physicians and health experts say that vaccinating children protects both them and the adults they come into contact with, such as grandparents and teachers.

Dr. Sanders, who founded his practice in 1987, began helping drug manufacturers test experimental drugs in children nearly 20 years ago. His office lobby has a 16-foot slide, where colorful murals illuminate the exam rooms.

Sanders Pediatrics helped test Pfizer’s COVID-19 vaccine in adults and adolescents, but Pfizer initially avoided using the site to enroll the youngest children, said Tim Hudek, who is also the director of Sanders’ drug. – Run test attempts. Pfizer wanted the researchers to dilute the dosage of the shots being made for adults at its site, not that the company was making them at a lower dose, Mr. Hudek said.

But dispatchers lacked sterile lab rooms and equipment to dilute shots for babies under 6 months old.

A Pfizer spokesperson said all sites that manufacture the lowest dosages must meet additional requirements to ensure that doses are properly assembled.

Dr. Senders considered installing necessary equipment and also tried to partner with hospitals. He enlisted a compounding pharmacy that mixes customized versions of drugs to order, which was owned by a former patient.

For the study, Lee Silsby Compounding Pharmacy, in nearby Beachwood, diluted the standard adult dose several times with a sodium chloride solution, until the dose was cut to 3 micrograms. Pfizer considers lower strength safe for children 6 months to less than 5 years of age.

Pharmacy doesn’t have much time to work. Pfizer-BioEntech Vaccine is stored at ultracold temperatures. Researchers only have two hours before the freezer-removed vial is thawed to inject the finished dose into a young study subject, or the shot will expire.

“We were sweating a little on the first day,” said Mr. Hudek.

On a recent morning, around 9:45, the dispatching researchers removed the vaccine vials from a freezer away from the rest of the staff and placed them inside a shoebox-sized metal container for transport to the pharmacy.

Emily Gorjank, a 23-year-old clinical research assistant, carried the lockbox outside her SUV. The storm was coming. Ms. Gorjanc has covered 4 miles from the middle of the rain to the pharmacy. About 20 minutes later, he saw a pharmacist sign the lockbox, then waited for the pharmacy to finish his job.

It took longer than usual. During the night, a typhoon temporarily shut down power to the pharmacy, delaying the cleanup needed to complete it before it could begin work.

At around 10:45 am, the pharmacy staff washed their hands, and wore gowns, face masks and gloves. At one time, they used to enter sterile rooms of the pharmacy to prepare vaccines.

Pharmacy technician Amber Rockwell sat on a covered laboratory bench called a hood, which was designed to contain any hazardous substances or contaminants. Working in the hood, Ms. Rockwell dilutes the vaccines and collects them into ready-to-use syringes.

Ms. Rockwell and a partner discarded some syringes that appeared to be contaminated and radioed for replacement. The Switch ate up precious minutes, but it avoided a potential disaster.

When coworkers asked what was taking so long, Ms. Gorjunk made her way to the back of the pharmacy—but outside the sterile room—in search of an update on time.

After about 45 minutes the pharmacy team was over. Ms. Gorjunk received the syringes, and returned to the dispatchers, arriving within only 30 minutes before the two-hour deadline.

Waiting in an exam room decorated with animal-themed wallpaper, Danita Jacksonbey of Lyndhurst, Ohio, with her children, Ava, then 2, and Coby, 8.

Community college administrator Ms. Jacksonbey had enrolled Coby in a vaccine study a few weeks ago, concerned that her asthma increased her risk of becoming ill. She was now signing Ava up, out of concern that her daughter might be exposed to the virus at daycare.

“They’re kids. It’s hard to keep that mask on and try to explain the virus to them,” Ms. Jacksonbey said.

Dressed in pink shorts and a matching top, with a bow in her hair, Ava sat on a countertop, swinging her legs back and forth as the syringe arrived. It had either a vaccine or a placebo.

She screamed when a researcher inserted a needle into her arm. Tears followed.

“You’re a superhero! You did!” said his mother.

Ava wasn’t over yet. She was due to return three weeks later for her second shot. In the meantime, her mother and researchers will monitor symptoms and whether she has become ill.