Twelve-year-olds are tween-agers, staring down puberty and middle school, surprisingly mature one minute and tortured by angst the next.
Some also are scientific pioneers, volunteering for clinical trials to test COVID vaccines in children. Slowly and gingerly, researchers are testing COVID-19 vaccines in younger and younger kids — even as millions of doses are pushed into the arms of their parents — with an eye toward FDA approval in the next year or two.
“People try to minimize how sick kids get with COVID, but that’s a mistake,” said Brigham C. Willis, senior associate dean for medical education and professor of pediatrics at UC Riverside’s School of Medicine. “I work intensive pediatric care, and there’s a minority who get extremely ill. There are some deaths. It’s not a non-entity.
“And even though a large majority of kids won’t get extremely ill, they can still contract and spread it. To get control of the pandemic, you have to vaccinate both adults and children.”
More than 300,000 coronavirus cases involving children younger than 17 have been reported in California since the pandemic began — more than 12 percent of the total. There have been six deaths — one child younger than 5, and five ranging in age from 5 to 17, according to state data.
One of them died in Los Angeles in December from multisystem inflammatory syndrome, or MIS-C, an extreme immune reaction linked to COVID. Another died this month in Stanislaus County.
“There have been deaths among kids with no high-risk factors,” said Grace Lee, professor of pediatrics at Stanford University School of Medicine and chief medical officer for practice innovation and infectious diseases physician at Stanford Children’s Health. “Sometimes we forget about it with the flu, but every year, kids die. About half had no serious underlying conditions. These are deaths that could have been prevented if we used all the tools in our tool kit to prevent unnecessary infection.”
With COVID, most critically ill kids seem to do OK over time, but the long-term side effects of the disease are still unknown, she said. “There’s a lot still to worry about. If it’s a preventable disease, why not use all your tools to prevent infection in those kids?”
Vaccine skeptics have a long list of reasons, but that battle looms on the horizon. Meantime, there’s great optimism that school will look nearly normal come the fall — long before vaccines are green-lighted for kids, and long before any COVID vaccination mandates that might follow.
Testing, testing, 1 2 3
Moderna is recruiting in several states for a vaccine trial involving children ranging in age from 12 to 17. In California, that includes La Mesa, with plans to recruit in Banning as well.
“Our goal is to generate data in the spring of 2021 that will support the use of (Moderna’s vaccine) in adolescents in advance of the 2021 school year,” said Stéphane Bancel, chief executive officer of Moderna, in a statement last month. “(T)his adolescent study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population. We hope we will be able to provide a safe vaccine to provide protection to adolescents so they can return to school in a normal setting.”
Eventually, Moderna plans to study its vaccine in kids aged 1 to 11.
The Pfizer vaccine, meanwhile, is already authorized for those 16 and older, and the company is testing how smaller doses of vaccine perform in more than 1,000 children ranging in age from 12 to 15. That’s in progress at medical centers in Anaheim, Long Beach, Los Angeles, Santa Clara and Walnut Creek, and in many other states and nations.
“When we complete our trial in 12- to 15-year-olds, we will assess the efficacy and safety findings and intend to start a trial in 5- to 11-year-olds,” said Pfizer Global spokesperson Keanna Ghazvini.
AztraZeneca and Johnson & Johnson are expected to test their vaccines in kids soon, too. And overseas, children as young as 3 are sought for COVID vaccine trials in China, and tween-agers are in trials in India as well.
It’s not simply that the immune systems of children and adults are different. A 15-year-old’s immune response won’t be the same as a 10-year-old’s, which won’t be the same as a 5-year-old’s, which won’t be the same as a toddler’s.
“We need to go as young as we can,” said George Rutherford, professor of epidemiology and biostatistics at UC San Francisco. “Around 1, after the first birthday.”
Eventually, infants will be protected by antibodies from their vaccinated mothers, and the under-1 set by having adults in the household vaccinated, he said. But experts need to know if the vaccine protects school-age children against disease or infection or both. And, if high schools are to return to something resembling normal soon, 16-, 17- and 18-year-olds must be bumped up the vaccine priority list. They’re more prone to illness than the youngest children, and Moderna’s vaccine already has emergency approval for that age group.
“That’s a gimme right there,” Rutherford said.
Steady as she goes
If it strikes you that clinical trials proceed at a much slower pace for kids than for adults, you’re correct.
“They’re a vulnerable population — we try to be extra careful with any research study involving children,” said UCR’s Willis. “You’re introducing a vaccine that’s intended to prevent harm, but it has risks, and you’re introducing it to a very healthy population.”
Researchers begin with very low doses and ramp up to determine the optimal dose that delivers the desired protection, he said.
“There’s a lot of work ahead,” said Stanford’s Lee. “I really would love them to begin clinical trial in the younger child population — we’re going to need to have that data. Is it safe? What are the efficacy considerations? I’m not a trialist and I know there are complicated considerations, but yes, I want it to move more quickly.”
Trial data from adults show that the vaccines are extraordinarily protective, and now that millions and millions of doses are going into adult arms, “we are going to have amazingly strong safety data in a pretty short time,” Willis said.
There’s no reason to think efficacy will be much different for children, but full FDA approval is likely years away nonetheless, he said. The virus will be waiting.
“It’s not likely that COVID is going to be eradicated from the earth,” Willis said. “There’ll have to be ongoing immunization efforts throughout the world, and kids will be a big part of that.”
He expects COVID vaccines will eventually be required to attend school — but not until after full FDA approval, which is quite a ways off.
“Other required vaccines have years and years of safety data. This does not,” he said. “There’s no evidence that there are any significant side effects, but in California, Arizona, it can be challenging dealing with the movement against vaccines.”
Mandate?
And many are, indeed, wary.
“My concern with launching clinical trials in children is that the vaccine is still experimental,” said Bob Sears, a San Juan Capistrano pediatrician on medical probation for actions related to his controversial views on vaccines.
“People have forgotten that the FDA hasn’t officially approved any COVID vaccines for general use. They have only granted emergency use authorization, which is allowed without verifying safety and efficacy, especially long term. If COVID was deadly for most children, such emergency experiments could be warranted. Since children experience the mildest disease, rushing into vaccinating them doesn’t seem like a good idea. Shouldn’t we wait until the FDA approves the vaccine for those who need it most, and enough time goes by so we know it’s safe?”
Sears also frowns on the prospect of eventually requiring COVID vaccinations for kids as a condition of attending school.
“Vaccine mandates only make sense for infections that are extremely dangerous to most people, and the vaccine is proven to prevent person-to-person transmission and community spread of the infection,” Sears said. “All we know so far, scientifically, is that COVID vaccines may reduce disease symptoms.
“So it wouldn’t make sense for any intelligent legislator to vote for this mandate for schoolchildren, for whom the disease is mildest of all, especially if it won’t reduce the spread. Then again, legislators have been known to vote without logic or common sense … from time to time.”
Many parents and students, meanwhile, are eager to get their shots and get on with it.
“I would be fine with that,” said Zachary Winslow, a seventh-grader at King Middle School in Berkeley, of a vaccine requirement as he protested school closures last week. “A lot of people are afraid of it, with what would happen. I think it would be great if everyone got it and we could go back to school.”
Lei Levi, a PTA president and mother of a first-grader in Berkeley, doesn’t want vaccine requirements to get in the way of reopening. That “just feels like another delay” and is unnecessary when data show schools have safely reopened without spreading the disease by following basic safety protocols, including masks, social distancing and sanitizing, she said.
Experts expect that, by fall and perhaps sooner, school will start to look much like normal. Research has shown that open schools don’t lead to significant spread, and the mass vaccination of adults over the coming weeks and months should ensure they’re safe — and inspire awe.
“The rapidity with which we developed a vaccine for a deadly, pandemic-causing virus should be celebrated, and we should be so excited,” said UCR’s Willis. “The fact that it works so well could be of incredible import for many diseases. Even though it’s been a dark time, this was an incredible advance for medicine — and could be a really important advance for mankind.”
John Woolfolk of the Bay Area News Group contributed to this report.
Source: Orange County Register
Be First to Comment