Since most families will have questions about vaccinating their children, we’ve tried to answer some of them.
Frequently Asked Questions
Should I consider vaccinating my child?
The Centers for Disease Control and Prevention and the American Academy of Pediatrics recommend vaccinating children who are eligible. Currently, that means those 12 and older, but the shots are being studied in younger children, and vaccine manufacturers will soon be requesting authorization for them from the Food and Drug Administration.
It is true that the coronavirus does not typically result in serious illness in children. But they are still at risk. Data shows that more than 4 million children in the United States have been diagnosed since the pandemic started, resulting in tens of thousands of hospitalizations and at least 300 deaths, though some researchers estimate the actual number of fatalities could be twice as high.
In addition, more than 4,400 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, according to the CDC.
Those numbers may not seem indicative of a significant problem for children when compared with the more than 37 million total cases and over 600,000 deaths across the United States, but health experts said that the virus is having an impact on youths.
To put it into perspective: 188 children died of influenza during the 2019-2020 season — mostly before the pandemic and precautionary measures such as social distancing. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said covid-19 is “right up there among the vaccine-preventable diseases as one of the more likely killers.”
Sean O’Leary, vice chair of the Committee on Infectious Diseases for the American Academy of Pediatrics, said because child fatalities are not common, the number of pediatric deaths related to covid-19 would put the virus in the top 10 causes of death among children.
But aside from protecting children themselves, vaccination makes sense for the greater good — to help reduce community transmission, get the country as close as possible to herd immunity and allow adults and children to get back to their pre-pandemic lives, experts said.
“The more people we can vaccinate, the more lives we’re going to save,” O’Leary said.
Is my child eligible?
Currently, children 12 and older can get the Pfizer-BioNTech messenger RNA (mRNA) vaccine.
Older teens have been eligible for the coronavirus vaccines since Pfizer, Moderna and Johnson & Johnson were granted emergency use authorization from the FDA. The Pfizer vaccine was initially authorized for people 16 and older, while the Moderna and Johnson & Johnson shots were authorized for those who are at least 18.
The Pfizer vaccine was recently cleared for use in younger adolescents, and clinical trials are underway to determine the safety and efficacy of the vaccine in children ages 6 months to 11 years.
Moderna is studying its mRNA vaccine in children from 6 months old to 17 years old.
And Johnson & Johnson said it is moving forward with adolescent clinical trials.
When will the vaccine be available for children under 12?
Anthony S. Fauci, the nation’s leading infectious-disease expert, has said there may be enough safety and efficacy data to start vaccinating children “of any age” by early next year, though the exact timeline is not certain.
The FDA has requested that both Pfizer and Moderna expand the size of their clinical trials for children ages 5 to 11 and will probably require two months of follow-up data before considering authorizing the vaccines for that age group. The intent is to help determine whether younger children are at an increased risk of developing a rare condition characterized by inflammation of the heart.
It is not clear how much safety follow-up data the agency will require for children under 5. That decision may depend at least in part on the results for the older children, according to a federal official was not authorized to speak publicly and spoke to The Washington Post on the condition of anonymity
In a letter to the FDA, the American Academy of Pediatrics urged the agency to consider how expanding the clinical trials could delay the shots for 5-to-11-year-olds. “It’s not clear what the additional benefit would be of enlarging the trials by a few thousand enrollees, and it risks the potentially large downside of delaying vaccines for that age group,” O’Leary told The Post. Federal officials have said safety is paramount in making their vaccine decisions.
Pfizer said it plans to submit trial data for children ages 5 to 11 in September and data for children as young as 6 months soon after that. The federal official who spoke on the condition of anonymity said it could take until November for the FDA to make a determination.
Moderna does not appear to be far behind.
Johnson & Johnson said it plans to start a Phase 3 study in adolescents ages 12 to 17 in the fall.
Is this the same vaccine that is administered to older teens and adults?
It is. The Pfizer vaccine that has been cleared for children 12 and older is the same vaccine given at the exact same dose.
But based on safety, tolerability and immunogenicity data from the Phase 1 study, it will be administered at a lower dose for children younger than 12 when it becomes available to them, Pfizer said.
Moderna is likely to do the same.
Is it FDA-approved?
The Pfizer vaccine has been approved by the FDA for people 16 and older but is still under emergency use authorization for adolescents ages 12 to 15. Moderna has submitted an application for authorization to offer the shots to adolescents.
What does that mean?
Emergency use authorization is a way to use unapproved medical products, such as vaccines, during public health emergencies. It is a rigorous process.
For full FDA approval, the clinical trial participants must be tracked for at least six months to monitor for serious adverse reactions. Pfizer has applied for full regulatory approval to use its vaccine in people 16 and older and will submit supplemental materials for the 12-to-15 age group once the appropriate length of time has passed and enough data has been collected. Moderna started its submission process to use the vaccine in those 18 and older in June.
Is it safe for children?
Older teens have been getting vaccinated for months, and U.S. clinical trial data for the Pfizer vaccine showed “no safety concerns” for 12-to-15-year-olds — the most recent group to get the green light for inoculation.
The vaccine was also 100 percent effective at preventing symptomatic coronavirus infection. Out of nearly 2,300 adolescents, there were only 18 cases of covid-19 — all in the placebo group.
Trials are ongoing for those younger than 12. Offit said once data is available for them, “then we’ll know whether or not the vaccines are shown to be safe and effective in those age groups.”
Will vaccination be required to return to school?
It is not clear whether vaccination will be required for school-age children in the fall. Those decisions are typically made at the state level and, at least so far, there hasn’t been a push from state legislators.
Dorit Reiss, a law professor focused on vaccine policy at the University of California Hastings College of Law, told The Post it is unlikely that the shots would be required before the vaccines are granted full regulatory approval.
Dozens of colleges, meanwhile, have already announced plans to require coronavirus vaccinations for their students.
Could it affect mask policies in the classroom?
Federal health authorities recommend universal indoor masking for all teachers, staff members and students older than 2, vaccinated or not, in K-12 schools to help protect against covid-19, particularly the highly contagious delta variant.
It’s unclear whether vaccination will be required in schools. But, in any case, O’Leary said it would be challenging for schools to track vaccination status at this time, so inoculating school-age children will probably not change the mask guidance, at least not for the 2021-2022 school year.
“The only thing that would change things much is if somehow we achieve really high vaccination coverage and see a really deep drop in covid-19 cases across the country, in which case those recommendations could change,” he said. “But, for now, I don’t really see the vaccination process necessarily impacting that particular issue.”
Can the coronavirus vaccination be given at the same time as other shots?
Yes.
The CDC and the American Academy of Pediatrics have stated that co-administration is acceptable.
Also, O’Leary stressed that regardless of whether families get their children inoculated against the coronavirus, they should make sure their children are caught up on other vaccinations. He said that during the pandemic there was a drop in childhood vaccinations, and once children start socializing, those who are unvaccinated will be prone to other vaccine-preventable diseases — “some of which are much more severe in kids than covid-19.”
What are the side effects?
As with adults and older teens, younger adolescents may experience side effects from the vaccination, including pain and redness at the injection site, as well as tiredness, headache, muscle pain, fever and chills. Younger adolescents have experienced side effects more commonly than older teens, and the side effects may be more intense after the second injection, according to the CDC.
The CDC said side effects should subside within a few days.
Although such events are rare, those who experience a severe or immediate allergic reaction to the first dose should consult a doctor before the second.
What about myocarditis?
There have been rare instances of heart muscle inflammation in vaccinated adolescents and young adults.
As of August, more than 1,300 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 young people in the United States who received a coronavirus vaccination.
The CDC and FDA have confirmed 762 reports, most of which occurred in teenage boys and young men after receiving one of the mRNA vaccines. Symptoms include chest pain, shortness of breath and heart palpitations. But more than 80 percent recovered on their own, according to the data. U.S. medical investigators are still assessing whether there is a relationship to the shots, the CDC said.
Earlier in the summer, the Advisory Committee on Immunization Practices, which makes vaccine recommendations to the CDC, reviewed the reported cases and determined that the benefits of the mRNA vaccines outweigh the risks of myocarditis and pericarditis.
The CDC said there has not been “a similar reporting pattern” among those who received the Johnson & Johnson vaccine, which is an adenovirus vector vaccine and is not authorized for people younger than 18.
All of that said, given that millions of teens and young adults have already received at least one dose of coronavirus vaccine in the United States, health experts said that if there is a link between the shots and the onset of myocarditis, it would be very small.
Offit said the incidence is about 1 in 20,000 to 1 in 50,000 people — meaning in a stadium of 100,000 people who received a vaccination, two to five of them might develop the condition (depending on their ages). The risk of developing myocarditis from covid-19 is much higher, he said.
A cohort study published in JAMA Cardiology looked at nearly 1,600 college athletes who underwent extensive cardiovascular testing after having covid-19 and found that 2.3 percent — or roughly 1 in 40 — had myocarditis.
And multisystem inflammatory syndrome, which is much more common and has been linked to the virus, can also cause heart inflammation.
“There are no risk-free choices; there are just choices that take different risks,” Offit said. “The goal of a parent is to make the choice that puts the child at lesser risk. And the vaccine puts the child at lesser risk than not vaccinating the child, knowing that the delta variant is highly contagious.”
Where can I find additional information?
With so much misinformation about vaccines, O’Leary said, families should be careful to get information from a reputable source, such as the child’s pediatrician or authorities such as the CDC, the American Academy of Pediatrics or the Immunization Action Coalition.
The vaccinations are provided free. To find nearby vaccination centers, visit Vaccines.gov.
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