As virus rages, parents confront tough decisions

Families are confronting difficult situations now that most schools have reopened after as many as 13 months of remote teaching in the pandemic.

As the highly contagious delta variant of the coronavirus has taken hold, dozens of schools around the country have closed classrooms or paused sessions, especially in states with low vaccination rates.

Forty-eight million children in the United States are under age 12 and not eligible yet for a vaccine endorsed by the Food and Drug Administration.

And about 252,000 children, including teenagers, tested positive in early September for the virus, the largest number of such cases since the start of the pandemic, according to an American Academy of Pediatrics analysis.

Of youths ages 12-17 who are eligible to get covid-19 shots, roughly 54% have received at least one dose. But public health experts say it will be months before the FDA decides whether the results of various clinical trials for those who are 5-11 and 2-5 merit authorizing the shots for the youngest age groups.

Leng Vong Reiff had just received her second dose of a covid-19 vaccine and thought guiltily of her two young, unvaccinated sons.

Like countless parents across the nation, she began searching for vaccine clinical trials for children. She managed to find one, applied and got a call back.

“They said that a clinic in Nebraska had an opening right now, four hours away,” she recalled. Better yet, this was a placebo-free trial, so she knew her sons would be given the bona fide vaccine.

A resident of Clive, Iowa, Vong Reiff bundled Logan, 9, and Quentin, 5, into her car and raced west on Interstate 80 to the clinic, where her sons received their first shots of the Pfizer vaccine. They returned three weeks later for their second shots, protecting them for the school year ahead. And they will go back in December for antibody testing.

Parental anxiety has fueled the demand for slots in children’s vaccine trials and made appointments scarce. Pfizer, for instance, is fully booked in its clinical trial, a spokesperson said.

So Vong Reiff was lucky to nab a slot in Nebraska.

There’s no question that this summer has been particularly trying for parents, especially after public health experts warned that the delta variant was highly transmissible — even among vaccinated household members. Although children still are less likely than adults, especially older adults, to be hospitalized or die from covid-19, nearly 30,000 children were admitted to hospitals with covid-19 in August, the highest levels to date during the pandemic.

The hospitalization rate in mid-August for children and adolescents with confirmed covid-19 was nearly five times the rate in late June, according to a study released earlier this month by the Centers for Disease Control and Prevention. That rate climbed nearly tenfold among children newborn to 4 years old, the report found.

With few options other than taking precautions like mask-wearing, some parents have even sought, through their pediatricians, off-label shots that are adult doses, a practice the FDA discouraged Friday. The agency warned that “children are not small adults,” and that the adult dosages now in wide use have not been fully studied for potential safety risks in younger children.

Impatient parents who are seeking off-label adult shots for their children concern officials like Dr. Sean O’Leary, vice chairman of the committee on infectious diseases at the American Academy of Pediatrics.

“It’s a bit of the Wild West out there,” said O’Leary, a professor of pediatrics at the University of Colorado Anschutz Medical Campus and Children’s Hospital Colorado.

NEED FOR VACCINE

In his push for vaccine mandates, President Joe Biden expressed the need Thursday to develop vaccines to protect children younger than 12.

“Now if you’re a parent of a young child and you’re wondering when will it be, when will it be — the vaccine — available for them, I strongly support independent scientific review for vaccine uses for children under 12,” he said. “We can’t take shortcuts of that scientific work.”

The three major U.S. drug companies making vaccines are at different stages when it comes to children’s trials.

Pfizer is conducting a single trial for children under 12, said Kit Longley, a spokesperson.

The trial has included 4,500 children in its first phase: 3,000 who are 5-11; 750 who are 2- 5; and 750 who are 6 months to 2 years. Its second and third phases include 4,500 children.

The company anticipates having its trial data for children ages 5-11 later this month, and after more review, potentially will request FDA emergency use authorization for that age group, Longley said Friday.

Moderna announced Thursday that the company had finished its enrollment of children ages 6-11, totaling 4,000 children, for its trial. The company said it expected to file for FDA emergency-use authorization for that age group by the end of this year.

Johnson & Johnson has started its Phase 3 clinical trial in adolescents from 12-17 and will submit the findings to regulators when finished, according to company spokesman Jake Sargent.

INTO TRIALS

Jennifer Macklom of Cedar Park, Texas, was determined to get her three daughters enrolled in a trial. Haunting her were the memories of 2016, when her daughter Miriam had grown sick with an adenovirus at age 2½. Simultaneously, her daughter Naomi, who was only 6 weeks old at the time, contracted a form of the coronavirus that predated covid-19.

Miriam was taken by ambulance to the Dell Children’s Medical Center in Austin, Texas. Naomi was admitted through its emergency room.

Both girls were placed on oxygen and hooked to feeding tubes at the same time, Macklom recalled.

“I said, ‘I can’t do that again. I can’t emotionally have anyone I love or even know be hooked up to one of these things,’” said Macklom, a high school mathematics teacher.

So, with the advent of the pandemic, she conferred with her pediatrician, and all three children landed on a waiting list for a vaccine trial. Miriam is now 8, Naomi, 5, and Ruth, 2.

Five months passed. Then the phone rang, and Macklom learned that her daughters were at the top of the list to receive the Pfizer vaccine at a branch of the Austin Regional Clinic in central Texas.

So many parents were interested in that trial for the under-12 age group that the staff had no need to recruit them, according to Heidi Shalev, a clinic spokesperson.

Ruth was too young for vaccinations at that site. Now, to avoid the risk of contracting the virus at day care, she is spending weekdays with Macklom’s parents.

Miriam and Naomi got their two shots. They don’t know if they contained the vaccine, since this trial called for onethird of shots to be a placebo. The children had to wait for an hour after the injections, and the staff gave them coloring books and rice crispy treats.

The girls will learn in early winter if they got the vaccine or the placebo. If it was the placebo, they will receive shots of the real vaccine.

“Getting in the study was so life-changing,” Macklom said. “We actually went out camping.”

SOLID EVIDENCE

Before the vaccines can be cleared for the 28 million American children ages 5-11 and the 20 million who are even younger, regulators need solid evidence that the shots are safe and that they reduce the risk of disease.

That’s typically an exacting and deliberate process, often taking years.

But in the midst of a pandemic sent into overdrive by the delta variant, “exacting and deliberate” is beginning to sound more like “slow and bureaucratic.” The nation’s pediatricians were growing impatient.

“The delta variant has created a new and pressing risk to children and adolescents across this country,” the American Academy of Pediatrics wrote in an Aug. 5 letter to the FDA. The doctors exhorted the agency “to carefully consider the impact of its regulatory decisions on further delays in the availability of vaccines for this age group.”

They responded Friday with an unusual public statement that acknowledged the urgency of its mission and promised to review clinical trial data “as quickly as possible, likely in a matter of weeks rather than months.”

Anxious over the emergence of a couple of rare side effects, the FDA in midsummer told vaccine makers to add more kids to their trials. Regulators also proposed that the trials track the kids for longer than they had initially planned. That would give safety experts a better chance of detecting rare side effects, as well as very delayed reactions to the vaccine.

Pfizer and Moderna responded by roughly doubling the size of their trials for younger children.

The sudden shift alarmed Stanford pediatrician Dr. Yvonne Maldonado, who chairs the American Academy of Pediatrics’ Committee on Infectious Diseases and is working on one of Pfizer’s pediatric clinical trials.

“It would have extended the timeline by several months,” she said. And as a statistical matter, a trial with twice as many kids would probably still miss a rare side effect. Plus, since post-vaccine reactions are most likely to take place within the two months after a shot, lengthening the follow-up was unlikely to add any insight, she said.

The challenge with clinical trials is that “you are essentially trying to predict the safety of a vaccine in billions of children by looking at its safety in thousands of children,” said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia.

But during a raging pandemic in which children are being hospitalized at growing rates, it’s costly to extend trials in hopes of catching faint safety signals. “It’s frustrating that children are back in school and that they’re not vaccinated,” Offit said.

Regulators are particularly keen to know more about a condition called myocarditis, which is swelling or inflammation of the heart muscle.

In early June, just a month after the Pfizer vaccine became available to 16- and 17-year-olds, the CDC documented a slight rise in cases of myocarditis in recently vaccinated people.

There’s always the possibility of an entirely unforeseen side effect, such as the blood clots that emerged in a small number of younger women who received the J&J vaccine. Although administration of that vaccine was briefly paused while the risk was investigated, shots quickly resumed.

In the middle of a pandemic, detecting rare or unforeseen side effects is a task best left until after a vaccine is authorized and large numbers of diverse people begin to get it, Maldonado said.

“This wait-and-see approach assumes that you know what you’re waiting for,” Maldonado said. “We don’t have the luxury of waiting three to five years for whatever that magical endpoint might be.”

Information for this article was contributed by Deborah Schoch of The New York Times and by Melissa Healy of the Los Angeles Times (TNS).

(The New York Times/Kathryn Gamble) Leng Vong Reiff poses with one of her sons at their home in Clive, I0wa. Reiff drove four hours to get her 9-year-old and 5-year-old sons inoculated as part of a Pfizer covid-19 vaccine trial. The boys have had both rounds of the vaccine and will go back for antibody testing in December.