Officials at the Food and Drug Administration have greenlighted Pfizer and BioNTech's COVID-19 vaccines for children ages 12 to 15 on an emergency basis.
More vaccination trials for those below the age of 12 are well underway, as teams at Pfizer and Moderna have fully enrolled trials for those as young as 6-months-old earlier this year.
Early trials point to 100% efficacy in teens and preteens, with more data forthcoming in 2021.
Parents may be able to begin vaccinating young children in September and babies in winter 2021, pending future FDA approval.
Younger teens and preteens aged 12 to 15 will soon be eligible to receive a vaccine after officials at the Food and Drug Administration greenlighted Pfizer's request on an emergency use basis in early May. Like those older than 16, these kids will be able to receive complete COVID-19 vaccinations before school begins this fall. Pending final approval from the Centers for Disease Control and Prevention, vaccines may be available for those as young as 12 as soon as this week in major cities like Seattle, explains Janet Englund, M.D., a professor of pediatrics at University of Washington Medicine and a pediatric infectious disease specialist at Seattle Children's Hospital.
Prior to seeking approval, research teams at Pfizer shared that its protein-specific mRNA vaccine was 100% 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.
While seeking approval, Pfizer revealed that vaccine side effects in the 12 to 15 age range were similar to adults. "Some of the interest data is the excellent antibody responses in this age group, a response that is even better than that of younger adults," Dr. Englund explained. "Fever was a relatively common side effect, however, at about 20% of participants — something that parents should be aware of."
More studies will need to be conducted in younger teens, by Pfizer as well as by other manufacturers and vaccine producers like Moderna and Johnson & Johnson. All will likely seek to get what's called "Emergency Use Authorization" from FDA officials. And the work won't stop there, as scientists 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.
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 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?
All manufacturers are underway in children's vaccine trials currently, according to Dr. Thompson. 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.
Dr. Fichtenbaum adds that teams at Moderna enrolled around 3,000 children between the ages of 12 and 18 in February; the company may seek similar emergency approval from the FDA by early- to mid-summer.
Dr. Fichtenbaum says that any company seeking approval for vaccine use in children will be looking to collect data through the first 57 days after receiving a shot, if not longer.
And while it's relatively far off, Dr. Englund adds that more research is being conducted on "certain high-risk adult and pediatric populations" with new formulations of vaccines that may not require special freezers for two shots currently approved. "Vaccine studies with new vaccines designed to have better efficacy against COVID-19 variants are also ongoing, and we should expect to see more of those studies [in children] beginning soon," she says.
When will kids get a COVID-19 vaccine?
The short answer: Pfizer vaccines will likely be administered to those between 12 and 15 years of age starting this month, Dr. Englund says. She adds that this age group will likely be largely vaccinated against COVID-19 by August or September, as demand has slowed in mass vaccination sites. It could be that some communities or locations are prioritized first over others, Dr. Englund adds, in a similar fashion to the need-based vaccine rollout adults saw earlier this year.
Those under the age of 12 may be able to receive a vaccine before 2022. In a recent company presentation, Pfizer officials shared that the company plans to apply for emergency authorization for vaccine use in toddlers and young children this September, CNBC reports. Pfizer may also seek approval for infants in November, as teams at Pfizer and BioNTech began clinical trials in children over the age of 6 months back in late March.
How will states prioritize children compared to adults?
Dr. Fichtenbaum says that he expects that a bulk of Americans who want their vaccine will indeed be vaccinated by the end of July, if not earlier. There's been a noticeable decline in demand for COVID-19 vaccines over the last few weeks, as detailed by this Time report, which means children's vaccination plans may not impact vaccine availability after all.
Robert Amler, M.D., a former CDC 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, even though the Pfizer mRNA product has been previously 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 trials have long included 16, 17 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.
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 reported cases of this particular variant in March, 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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