COVID-19 vaccination trials for adolescents between the ages of 12 and 15 and younger children are well underway. Early results suggest vaccines could be 100% effective in younger teens, according to new reports.
Experts say Pfizer and Moderna have fully enrolled trials for kids ranging in ages from 6-months-old to 18 years old earlier this year.
Parents may be able to begin vaccinating their children this summer, pending approval from the Food and Drug Administration later this spring.
Many parents may feel relieved after news regarding early COVID-19 vaccine trials in individuals under the age of 16 suggests they are just as effective in this age group as in adults. Research teams at Pfizer recently shared that its protein-specific mRNA vaccine was entirely effective in preventing COVID-19 spread among 12 to 15-year-olds. The manufacturer's study involved 2,260 teens and pre-teens in the U.S., and none of the vaccinated participants ended up contracting COVID-19 throughout the entire study. More importantly, however, side effects observed for these younger teens were similar to those noted in adults. Furthermore, adolescents in the trial produced more vaccine-made antibodies to SARS-CoV-2 (the virus that leads to a COVID-19 diagnosis) compared to older teens and young adults in earlier 2020 trials.
But Pfizer's first study is just one of many trials that will need to take place before kids under the age of 16 can think about getting vaccinated. It's not that vaccines will be hard to get, either; President Biden just again accelerated timelines for near-total eligibility for any American to April 19. It's that more studies need to be conducted in younger teens, by other manufacturers and vaccine producers who may seek to get what's called "Emergency Use Authorization" from officials at the Food and Drug Administration. And the work won't stop there, as scientists will need to conduct even more vaccine trials on children below the teen threshold, including toddlers, preschoolers and elementary-school-aged kids in the coming months.
Parents may be surprised to hear, as some aren't even eligible for their own vaccine just yet, that trials are already well underway for children in this young age group. Because manufacturers have already proven that vaccines can prevent COVID-19 infections and spread among adults, new trials focused on children will simply look to confirm similar antibody responses in kids and a lack of any serious side effects, explains Chris Thompson, Ph.D., a professor of biology at Loyola University Maryland. Both Moderna and Pfizer are looking for between 5,600 and 6,500 children in age groups from six months old to 15 years old, Dr. Thompson says, in different trials respectively; each trial will follow these kids' progress for at least 2 to 3 months before data is shared.
The big question still remains: Will my child be able to get a vaccine and head back to in-person learning safely this school year? A panel of experts break down trials, data, and expectations for Good Housekeeping, and with their help, we're piecing together a timeline for when kids may potentially be eligible for vaccines.
When will parents know more about vaccine safety and children?
Nearly all manufacturers are underway in vaccine trials currently — Pfizer and Moderna may have kicked off smaller studies in children back in December, according to Dr. Thompson. In fact, enrollment periods for the necessary safety trials in children may already be full for these two manufacturers specifically, explains Carl Fichtenbaum, M.D., a professor of clinical medicine at the University of Cincinnati's College of Medicine as well as a medical director of a Moderna-sponsored vaccine trial in Ohio.
"Because both manufacturers have fully enrolled their numbers of children from 12 to 16, it should be soon that they'd accumulate the antibody data and preliminary information on efficacy," Dr. Fichtenbaum adds. "I would expect that Pfizer may submit for a summertime EUA at the latest; Moderna enrolled about 3,000 children between 12 and 18 in February, so I would expect a similar timeline."
Dr. Fichtenbaum says that any company seeking approval for vaccine use in children will be looking to collect data through "Day 57," if not longer: "Once they've reached that point in time, they'll be able to go to the FDA... Bottom line is that Pfizer's EUA application may come quite soon, as they have the data. Moderna may look closer to May or early June."
As long as data submitted to the FDA remains as promising as Pfizer's early announcement, Dr. Thompson says that there's a strong likelihood teens and preteens will be approved for vaccines this year. "It looks really good; there are only 18 cases of COVID-19 in the placebo group, and there were none in the vaccinated group, so they're calling that 100% protection," he adds. These vaccine trials are necessary to confirm that vaccines can prevent severe infections; kids, in particular, are being watched for risk levels associated with multi-system inflammatory syndrome in a COVID-19 infection, which health officials say is rare but a severe threat.
When will kids get a COVID-19 vaccine?
The shortest answer: Pending FDA approval, children over the age of 12 may be able to be vaccinated starting in July and August, per Dr. Fichtenbaum. That age group, and potentially some ages below it, should likely be largely vaccinated across the country against COVID-19 by the end of November 2021, he adds.
Both experts point out that children under the age of 12 haven't been as extensively studied as of yet — trials may just be starting this month for that age group. "I'm thinking a year from now, we may see some EUA approvals come through for kids between five and 11 years of age, just a bit before we see any updated advice for babies and toddlers under the age of five. Since those kids aren't school-aged just yet, they're less of a priority for researchers and the country right now, I'd guess," Dr. Thompson says.
How will states prioritize children compared to adults?
Are you worried that a new eligibility pool may impact when you'll be likely to get your own vaccine... let alone your child's? Don't be. Dr. Fichtenbaum says that he expects that a bulk of Americans who want their vaccine will indeed be vaccinated by the end of July; an earlier time frame than when he expects the FDA to greenlight emergency use of the vaccine in younger teens and preteens.
Robert Amler, M.D., a former Centers for Disease Control and Prevention officer and the dean of the school of health sciences and practices at New York Medical College, explains that vaccinations for those between 16 and 18 years old followed authorization by about two weeks. Dr. Amler adds that each state may change priorities based on the addition of younger children to the list, but many previously prioritized groups would probably have been already vaccinated.
It's likely that children under 16 will be able to enjoy a smoother vaccination process in terms of logistics and scheduling for this reason.
Should my teenager get a COVID-19 vaccine now?
Some parents may be apprehensive to vaccinate teenagers at the moment, as the Pfizer mRNA product has been authorized for use in those as young as 16 years old. A recent survey conducted by ParentsTogether, a nonprofit family advocacy group, suggests that only 58% of 2.5 million American parents or caregivers would currently vaccinate a child against COVID-19, despite 70% of the same group admitting they're planning on getting vaccinations themselves.
If you're hoping to see more data from trials before making a decision, consider the fact that Pfizer's trial strategy at this point has long included 16, 1, and 18-year-olds. "Manufacturers presented evidence demonstrating that the vaccine is safe and effective in those age groups," Dr. Amler said. All experts agreed: If your child falls within the 16 to 18-year-old age range, getting them vaccinated can be crucial for safety as new variants pose risk in social settings.
New evidence suggests that SARS-CoV-2 variants, particularly the B 1.1.7 variant that is thought to have originated abroad, may infect teens and children more readily. In Minnesota, for example, nearly 750 schools have reported cases of this particular variant in March alone, per The Hill. Vaccines, then, can help negate the spread of new variants among teens as they're proving to be a vector for spread at the moment.
"Pfizer has run trials in people between the ages of 16 and 18: they've seen that they do produce antibodies that are nearly equivalent to those over the age of 18," Dr. Thompson says. "We know the efficacy is there, and in studies, [researchers] didn't see any safety issues. At this time, it doesn't seem like getting vaccinated at 16 or 17 would be problematic. It's kind of simple, if you think about it, in that [researchers] saw that it works firsthand."
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