If you have a child younger than 12, you’re likely feeling stuck in a jam again as schools reopen while pediatric COVID-19 cases are surging. Adding to the anxiety is a recent Washington Post report on an alarming model that suggests 75% of students will have contracted COVID-19 within three months in elementary schools that don’t adopt masking or virus testing protocols.
And though tweens and teens are eligible to be vaccinated (and millions have been), parents of children under 12 are still waiting. Aside from masking up and avoiding crowded indoor settings, it feels as if there’s still not much that parents of younger kids can do.
So HuffPost Parents spoke with several experts about where we are in the process of getting kids under 12 vaccinated and why the process seems to be taking longer than expected.
Experts are split on whether it’s still possible in this calendar year.
For some time, the goal was to start getting shots in the arms of younger kids in September. No one expects that to happen now. But Dr. Anthony Fauci, the nation’s top infectious disease expert, has said that there’s still a “reasonable chance” that kids younger than 12 will be eligible for a coronavirus vaccine before we head into 2022 — perhaps sometime in the “mid-late fall.”
Many other experts, including the surgeon general, have also said publicly that kids ages 5 to 11 will be eligible this year. The director of Pfizer recently laid out a scenario in which the drug manufacturer would have trial data available in September, submit an emergency use authorization application to the Food and Drug Administration in October, then hopefully have a vaccine for 5- to 11-year-olds approved by “late fall, early winter.” Vice Adm. Vivek Murthy, the surgeon general, added that was an “optimized” scenario, however.
Other high-profile health experts have expressed skepticism about those timelines. In a recent interview with NPR, Francis Collins, director of the National Institutes of Health, suggested they’re unlikely.
“Pfizer thinks that maybe by the end of September they’ll be ready to send in their trial data [to the FDA], and then the FDA will have to review it. I’ve got to be honest, I don’t see the approval for kids 5 to 11 coming much before the end of 2021,” Collins said.
And again, all of those predictions are for children ages 5 to 11. Younger children are unlikely to be eligible for a vaccination until 2022. Pfizer has indicated, for example, that it will not submit its trial data to the FDA until November at the earliest for that group.
It’s important to remember: Trials always take longer in kids.
“Pediatric studies always take longer. When you’re rolling out a medication or vaccine for children under 12, it’s normal for it to be delayed,” said Margaret Aldrich, director of pediatric infection control at Children’s Hospital at Montefiore in New York City, who emphasized to HuffPost that she is not involved in any of the ongoing trials and therefore does not have any kind of “inside scoop” on what is happening.
The trials happening in younger children right now are focused on dosing, in much the same way that the initial trials focused on dosing in adults. Those studies were prioritized because adults have, since the start of the pandemic, been at greater risk of hospitalization and death.
“They tested different doses in adults of varying ages, and the doses they landed on were the doses that were most immunogenic, especially in people over 65,” explained Kawsar Talaat, a professor at the Center for Immunization Research at Johns Hopkins Bloomberg School of Public Health and the Johns Hopkins Vaccine Initiative. The trials also investigated whether those doses were safe and tolerable in terms of side effects, she explained.
Those are the questions being studied in younger kids right now, and Aldrich said that dosing can be “a little harder to assess in younger children,” which is why it takes longer.
It is also important to bear in mind that trials in children have particular logistical hurdles. Researchers must find enough families willing to sign their children up (though Aldrich noted that thousands of families signed up for the trials once they were enrolling). Parents need to think through issues, such as taking time off work to attend appointments with their kids. The consent process is different with studies in children, too. That’s all to make sure that children are kept safe, but it can slow down the process.
The FDA did recently ask Pfizer and Moderna to expand their studies — but that’s not a red flag.
One reason why the trials are taking longer than estimated in some earlier predictions is due to the fact that at the end of July, the FDA asked both Pfizer and Moderna to expand the number of children enrolled in their ongoing trials. They wanted to better understand how many children might develop myocarditis, or inflammation of the heart muscle, which has been reported as a rare side effect in fully vaccinated adults.
But experts say, emphatically, that the expansion is not a sign that researchers are worried about general safety or efficacy in children. The vaccine has been given to hundreds of millions of adults already and has proved very safe.
Also, myocarditis happens really infrequently. There have been only about 1,300 events reported to the Centers for Disease Control and Prevention, all among people 30 and younger, among more than 363 million doses of the vaccine that have been given to date in the U.S. So it’s not even clear whether the expanded trials in children will do any better at capturing the risk of heart inflammation in them.
Instead, the agency may have asked for that extra data to help facilitate the process of seeking full approval for the vaccines in younger children months down the line, said Talaat — quickly adding, however, that she’s not privy to the agency’s thinking.
“It sounds like they will not use this for emergency use authorization as much as for the full licensure,” she said. (The FDA granted full approval to the Pfizer-BioNTech vaccine for people 16 and older just last week but has allowed it to be distributed since December under an emergency use authorization.)
In the meantime, there is still plenty parents can do to keep their kids safe.
Given that experts still aren’t clear about whether we’re looking at a November/December timeline for vaccines or more like January/February, it is reasonable for parents to hope for the best but plan for the worst.
Right now, that means continuing to adhere to proven preventive measures that work, even with the delta variant circulating: masking, hand-washing, social-distancing and “cocooning” children who can’t yet be vaccinated by ensuring everyone who spends time around them has been immunized if they can be.
The recent model that suggested three-quarters of children will be infected with COVID-19 within the first three months of school, for example, also showed that universal masking would reduce infections by 26% to 78%, depending on what other protections were in place.
“I cannot say this enough: Every adult in your child’s life needs to be vaccinated,” Aldrich said. “That is going to protect your child until your child has a vaccine.”
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.