The Food and Drug Administration authorized the coronavirus vaccine Friday for children 5 to 11 years old. About 28 million additional children will be eligible for the two-shot regimen, issued three weeks apart.
The vaccine must still clear additional hurdles: an advisory panel to the Centers for Disease Control and Prevention must recommend how to use the vaccine, and the shots cannot be administered until CDC director Rochelle Walensky gives the green light. The panel meets Tuesday and Walensky is expected to sign off on the vaccine the same day, allowing immunizations to start immediately.
Children are contracting COVID-19, the illness caused by the coronavirus. And whether it makes children ill themselves or is spread by them to other members of their communities, vaccines can help stave off deadly mutations and prevent serious illness, experts said.
“The most important thing about vaccination is that we want to prevent serious illness and death in children, decrease infections and prevent further variants,” said Jennifer Shu, a pediatrician and spokesperson for the American Academy of Pediatrics.
Shu said parents and guardians should speak with their children’s pediatricians with any questions or concerns about the vaccine. We have also tried to answer some common questions here and will be updating as more information becomes available.
— When will the vaccine be available for children ages 5 to 11?
There is no set date for when the vaccine will be available for these younger children. However, CDC advisers are scheduled to meet Nov. 2 to make recommendations. When Walensky approves the vaccine, likely on the same day as the meeting, providers will be able to administer it.
— Will it be the same vaccine given to children 12 and older?
Children ages 5 to 11 will be given one-third the dose that is given to adolescents, teenagers and adults. Pfizer and its German partner BioNTech said in a statement the lower dosage was selected for use in the clinical trial “based on safety, tolerability and immunogenicity data.”
However, younger children will still likely receive two doses, 21 days apart — the same regimen for older children and adults.
— Should younger children even be vaccinated against COVID-19?
Some parents have questioned whether younger kids need the vaccine, particularly given that children tend to — but not always — have less severe illness than adults and COVID-19 infections have been declining nationwide.
Federal data shows 1.9 million U.S. children between ages 5 and 11 have been infected with COVID-19 since the start of the pandemic. More than 8,300 have been hospitalized — many requiring intensive care — and 94 have died, according to the American Academy of Pediatrics.
“So this is a disease of children,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
Overall, nearly 6.3 million children in the United States have tested positive for the coronavirus, resulting in more than 20,000 hospitalizations and more than 500 deaths, according to the most recent data from the American Academy of Pediatrics.
In addition, more than 5,200 children have suffered a rare but serious condition called multisystem inflammatory syndrome (MIS-C), which is associated with COVID-19 and can cause inflammation of the heart, lungs, kidneys, brain, eyes and other organs, the CDC said. The median age of patients who have developed the condition is 9, and half of them were between the ages of 5 and 13, according to the data.
Those numbers may not seem indicative of a significant problem for children when compared with the more than 45 million total cases and over 730,000 deaths across the United States, but health experts have said the virus is having an impact on kids, even young ones.
Offit said, in particular, the highly contagious delta variant “has reached down to the other age groups.”
“They’re a vulnerable population because they’re not vaccinated — the less than 11-year-olds are not vaccinated,” he said.
In the clinical trial, the vaccine was shown to be safe and more than 90 percent effective for children ages 5 to 11 during a time when the delta variant was the dominant strain, according to the vaccine manufacturer.
“If you can tell me that over the next couple of months, the incidence of this virus will dramatically decline, then great,” Offit said. “But you’re heading into the winter months with a virus that is, at its heart a winter virus, and you’re going to have children getting together all in one place, most of whom are unvaccinated. That’s not a good recipe. So were I the parent of a 5- or 6-year-old child, I would vaccinate them in a second.”
— Should I be concerned about myocarditis?
There have been very rare instances of heart muscle inflammation in vaccinated adolescents and young adults. The FDA advisers said Tuesday that the benefits of the shot outweighed the risks of the rare heart conditions, voting 17-0 with one abstention to back the vaccine for children ages 5-11.
As of Oct. 20, nearly 1,700 reports of myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the outer lining of the heart) were reported to the Vaccine Adverse Event Reporting System (VAERS) among people 30 and younger in the United States who received a coronavirus vaccination. At least 220.9 million Americans have received at least one vaccine dose, including about 54 percent of people ages 12 to 17 and 63 percent of people 18 to 39.
The CDC and FDA have confirmed more than 900 reports, most of which occurred in adolescent boys and young men after receiving one of the mRNA vaccines. But because of this, the FDA added a warning about potential risks to the Pfizer and Moderna fact sheets and requested larger clinical trials for children ages 5 to 11 to determine whether younger kids are at an increased risk. In five out of six modeling scenarios put together by the FDA, the benefits of the shots outweigh the risks due to myocarditis for children ages 5 to 11.
U.S. medical investigators are still assessing what the relationship to the shots might be, the CDC said. Symptoms include chest pain, shortness of breath and heart palpitations. But the vast majority experienced a full recovery, according to the data.