Eight months after adult Americans began receiving COVID-19 vaccines, children under 12 are still not eligible for the shots.
That’s left a lot of parents worried their children might get sick – and might get others around them sick, as well.
Children can catch COVID-19 and pass it on to others. Luckily, they are less likely than adults to become seriously ill. Roughly 4.5 million American children have become infected with COVID-19 since the beginning of the pandemic, according to the American Academy of Pediatrics.
That number has risen lately, however, with children making up a higher proportion of the seriously ill. Many adults are protected by vaccines and the highly contagious delta variant now accounts for most of the infections in the U.S. Across the country. About 180,000 children have been infected in the past week, the American Academy of Pediatrics says.
We pose and answer several common questions about young children and COVID-19 vaccines:
What age group can currently get COVID-19 vaccines?
Only adults are eligible to receive the Moderna and Johnson & Johnson vaccines because their studies in children have not yet been completed.
Why aren’t COVID-19 vaccines available yet for kids under 12?
Traditionally, drugs are studied first in adults and then move to adolescents, then children, then younger children, as they are proven safe and effective in each group.
With COVID-19 vaccines, large clinical trials in adults (and in the case of Pfizer-BioNTech, older teens) took place in the second half of last year and studies in teens and then younger children began earlier this year.
More colleges are requiring the COVID-19 vaccine. Some are starting to kick out unvaccinated students.
What’s the status of clinical trials on younger children?
All three companies are studying their vaccines in children, first in adolescents, then 5- to 11-year-olds, then 2- to 5-year-olds followed by infants, 6 months and up. Younger babies are believed to have some protection from their vaccinated mothers. Last week, the Centers for Disease Control and Prevention recommended that pregnant people get vaccinated to protect themselves because they are at higher risk for a serious COVID-19 infection, and their unborn child would receive some protection.
Because the vaccines were already proven safe and effective in tens of thousands of adults, the studies in children have been allowed to be smaller – on the order of 3,000-4,000, instead of 30,000-40,000.
Children are less likely to become seriously ill with COVID-19 than older adults, with risks generally declining with age. So regulators want to make sure that vaccines are safe enough to justify use in each age group.
Advisory panels to the CDC and the Food and Drug Administration decided that the benefits outweigh the risks of the Pfizer-BioNTech vaccine for adolescents age 12 to 15.
Pfizer-BioNTech has said its study in children ages 5 to 11 should be completed early this fall, and in younger children early next year.
Moderna began its trials several months after Pfizer-BioNTech, so it is likely to complete its trials some time later, though it has not released a detailed timetable.
In May, the company showed its vaccine was safe and extremely effective in adolescents. Out of 3,700 12- to 17-year-old volunteers, no one who was fully vaccinated with the active vaccine developed the virus, the study found.
J&J hasn’t yet started its studies in minors, though it is in active discussions with the FDA to begin four trials with a minimum of 4,500 children. The first trial, in adolescents 12 to 17, is expected to begin this fall with the others to follow.
When will the COVID-19 vaccine be available for kids under 12?
The FDA requires longer-term follow-up data on children than adults, “to make sure that the safety is adequate,” according to Dr. Peter Marks, who heads the FDA division tasked with reviewing vaccines.
The FDA has not given a sense of how long it would take to review the research, but previous emergency use authorization requests have taken as long as eight weeks, suggesting that vaccines are unlikely to be available to grade schoolers until very late this year or early next.
Two- to 5-year-olds should be able to get shots by the end of winter or early spring 2022.
Is the vaccine dosage the same for children as adults?
The dose is the same for 12- to 15-year-olds as for adults, but dosage for younger children is likely to be lower. That’s one of the things being worked out in the trials.
In early trials, Pfizer-BioNTech said 112 children received doses of 10, 20, or 30 micrograms, with an option for 3 micrograms in the youngest children.
Currently, they are testing 10 micrograms in 5- to 11-year-olds and 3 micrograms in children under 5. Adults and adolescents get 30 micrograms.
Is the COVID-19 vaccine safe for kids?
In adolescents, the vaccines seem to be as safe as they are in adults, though teens may be more likely to suffer side effects like post-vaccine pain, fatigue and fevers.
The risk of heart inflammation, called myocarditis, also appears to be higher in younger people, particularly males, after vaccination.
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Why shouldn’t parents try to vaccinate their younger children now?
Legally, now that the Pfizer-BioNTech vaccine has received full FDA approval, doctors can prescribe it to anyone, including young children.
But the FDA and leading pediatricians warned this week that it’s a terrible idea to give shots designed for adults to children under 12.
The dose is likely to be more than they need, causing unnecessary side effects, according to the American Academy of Pediatrics, which has urged the FDA to expedite the process of authorizing shots for younger children.
Contact Karen Weintraub at [email protected]
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