For a period of time this spring and early summer, it seemed as though the United States had turned a corner in the COVID-19 pandemic. Cases and hospitalizations fell, restrictions were loosened, and older children became eligible for vaccination. But as we head into August, the pandemic has changed again. The delta variant is surging and mask mandates are back — all while children under the age of 12 still aren’t able to get vaccinated.
So HuffPost Parents spoke with several experts to learn what’s going on with the COVID-19 vaccine trials in children right now, and what, if anything, parents should be doing to prepare for whenever they are available for younger kids.
The trials going on right now are largely focused on dosing.
The Pfizer and Moderna trials that are currently ongoing in children under the age of 12 are looking at the safety of mRNA vaccines in younger children. This means scientists are looking at what kinds of reactions kids under 12 might have to the vaccine, as well as immunogenicity — basically, how much of an antibody response the vaccine generates.
But it’s not as though researchers are starting from square one.
“The fact that this vaccine has been in hundreds of millions of adults at this point is incredibly reassuring,” said Dr. Kawsar Talaat, a professor with the Center for Immunization Research at Johns Hopkins Bloomberg School of Public Health and the Johns Hopkins Vaccine Initiative.
Right now, researchers are pretty heavily focused on how much of the vaccine children require. Unlike with teens and adolescents, who receive the same dosage as adults, both Pfizer and Moderna are now testing lower doses in their ongoing trials with younger children.
“The first step that has had to be undertaken by companies is to do a dose-finding study, which takes time. You have to try different doses to see which dose you really need. For some vaccines, you actually need more for children. For some vaccines, you need less for children,” Dr. Janet Englund, a professor of pediatric infectious diseases at Seattle Children’s Hospital, told HuffPost.
Those dose-finding studies take an extra two to three months, she added, because the mRNA vaccine is given twice, and researchers are looking at the antibody response one month after the second dose — one reason why the trials in younger children have taken more time.
Some experts say vaccination could start this fall; others think winter is more likely.
Researchers and health officials have been loath to say when it’s likely younger children could be eligible for the COVID-19 vaccine, though some initially expressed optimism that they’d be eligible by the time school starts in the fall. And the timeline potentially became murkier this week when The New York Times reported that Pfizer and Moderna are, at the FDA’s urging, both expanding their trials of 5-to-11-year-olds to detect rare side effects, including heart inflammation.
But many experts still believe children in that 5-to-11-year-old cohort could be eligible for vaccination this fall — though not before schools open. According to The New York Times, Pfizer may still be able to meet the FDA’s reported request for a larger trial size and file a request to expand emergency authorization by the end of September. Moderna’s timeline is a bit longer. A spokesman for Moderna told The New York Times the company expects to seek emergency authorization for its vaccine in children age 6 to 11 by the end of this year or early next.
And the rollout will most certainly be staggered by age.
“My guess is that the first group that will get [emergency use authorization] next will be the 5-to-11s, so the school-age kids,” said Talaat.
“We go down in age. We did the older kids first, so we’re going to have that data first,” she explained, noting the practical challenges of enrolling children in trials like this during the best of times, but particularly during a pandemic.
Talaat added, however, that the data in younger children would probably follow pretty soon thereafter — within “a month or two.”
The delta variant makes the need for vaccinating young kids even more pressing.
The delta variant, which first emerged in India, is far more contagious than the original virus strain, and while there have been breakthrough cases among those who are fully vaccinated, it disproportionately affects those who are not.
And because young children are ineligible for vaccination — and many of the tweens and teens who are eligible have not been fully vaccinated to date — kids are making up a larger portion of new cases.
“Certainly the percentage of children, as a proportion of the total number of cases of COVID has gone up, because the adults are being vaccinated. So there’s fewer cases in adults, and proportionately more cases in children. And certainly the Delta variant is much more contagious,” Talaat said. “Is it more serious? We don’t know.”
That makes precautions like masking and maintaining social distance — particularly indoors — important for children these days, and the CDC has recently joined the AAP in calling for universal masking in K-12 schools this fall.
“Make sure that your child is wearing a mask, and that people around them are wearing masks, and just try to protect your children until they can be vaccinated, because rates are going up everywhere,” Talaat said.
Parents can take steps to prepare for when the vaccine is available.
Parents who have any questions about the safety or efficacy of the vaccines should absolutely reach out to their child’s pediatrician now to start a discussion — knowing, of course, that they won’t have answers to many questions until the clinical trials are over.
It’s also important to stay up-to-date with other vaccinations, Englund urged, because it’s not yet clear whether children would be able to receive their COVID-19 shot and additional immunizations at the same time — and there has been a drop in childhood vaccinations during the pandemic.
“Our children absolutely need to be up-to-date on their other childhood immunizations,” said Englund.
“I think — I don’t know — but I think we would prefer to give COVID-19 vaccines separately from other vaccines until we know better. So what parents can do is make sure their children are up to date on other vaccines, so that when a vaccine does come out their child can get in line early to get it,” she said.
Also, if there are unvaccinated adults or tweens and teens in your household, getting vaccinated now could certainly confer protection to younger children while they’re still ineligible.
“You vaccinate everybody in your household who is eligible for vaccination,” Dr. Tina Tan, attending physician in the Division of Infectious Diseases and a professor of pediatrics at Northwestern University’s Feinberg School of Medicine, previously told HuffPost. “So that if that child goes on vacation, and everybody who is around them that is eligible for the vaccine has gotten that vaccine, it’s much less likely that the child will be exposed to — and get — COVID.”
Experts are still learning about COVID-19. The information in this story is what was known or available as of publication, but guidance can change as scientists discover more about the virus. Please check the Centers for Disease Control and Prevention for the most updated recommendations.