COVID-19 vaccines from Pfizer and Moderna have officially been authorized for kids 6 months and older. The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) both gave their approvals, allowing vaccine distribution to begin this week. To answer your top questions, Parents spoke with Dr. Anthony Fauci, Chief Medical Advisor to President Biden, about distribution, effectiveness, benefits of vaccination, and more.
Why Did Vaccine Approval Take Longer for Young Kids?
Vaccine eligibility for babies, toddlers, and preschoolers is a major step in the fight against COVID-19, but many parents are wondering why it’s so delayed. After all, adults first got the green light for vaccination about one-and-a-half years ago. In short, “it really has to do with the vulnerability of children,” explains Dr. Fauci. Children have different bodies and immune systems than adults, so it takes longer to establish safety data.
Whenever you're testing an intervention (like a drug or vaccine), "you must always prove its safety and efficacy in adults before you move ahead with children because of their special vulnerability," says Dr. Fauci, adding that this process can result "in a bit of a delay" sometimes. "You should always be confident of the product in adults before you make it widely available in children—and that's exactly what happened here."
Indeed, after months of clinical trials establishing dosing and safety data, the FDA and CDC proved that the vaccines were effective in young children without serious side effects. They signed off on Pfizer's vaccine for kids ages 6 months through 4 years old, given as three low doses of 3 micrograms each. The two-dose regimen of Moderna's vaccine (25 micrograms each) has also been approved for children 6 months through 5 years old.
Where Can Parents Get Their Children Vaccinated?
According to Dr. Fauci, the U.S. Department of Health and Human Services has already shipped out large amounts of the vaccine. It will be available nationwide at pediatrician’s offices, community health centers, rural health clinics, children’s hospitals, community organizations, and pharmacies (but note that some pharmacies can’t vaccinate children under 3 years old).
"There should be a pretty good supply of vaccines at the local level for families who want to vaccinate their children," says Dr. Fauci. "The formulations have already been prepared in anticipation for this approval from the FDA and CDC, so I don't anticipate any problems—and if there are, hopefully they can be corrected quickly."
On June 9, the Biden Administration outlined plans for vaccine distribution in preparation for the FDA and CDC approvals. The White House’s strategy involves providing access to 10 million doses of Pfizer and Moderna, with “millions more available in the coming weeks,” according to a fact sheet. The majority of children (85%) will live within five miles of a vaccination site. Vaccines will be available in 100-dose packages, which is ideal for smaller and rural practices, and the shots will be encouraged through government initiatives like the Women, Infants, and Children (WIC) Program.
How Effective Are COVID Vaccines For Younger Kids?
Moderna’s clinical trial results showed 51% effectiveness for people under 2 years old and 37% effectiveness for those between 2 and 6 years old—but it largely prevents severe illness, hospitalization, and death. “It’s clearly effective and safe,” says Dr. Fauci. “The antibody levels are comparable to those levels in adults or older children.”
On the other hand, preliminary clinical trial data demonstrated that Pfizer’s vaccine is 80% effective against symptomatic Omicron illness, though this number will likely change as more research is conducted. Pfizer’s data isn’t enough to indicate efficacy clinically, but “the antibody data is really good,” says Dr. Fauci. You can predict “with good degree of confidence” that it will be clinically effective for the younger children.
It’s also important to note that researchers reported no flag flags and minimal side effects for both vaccines. Common complaints include low-grade fever, arm soreness, fatigue, and redness around the injection site—and the symptoms usually go away in one day, according to Ashish Jha, M.D., MPH, the White House’s COVID-19 response coordinator, in a previous interview with Parents.
Researchers didn’t find any instances of myocarditis (inflammation of the heart muscle) in clinical trials. This side effect has been reported in males under 30, usually after the second dose of the vaccine, but it remains extremely rare. Also, myocarditis is more common after COVID-19 infection than vaccination.
Why Should Young Kids Get Vaccinated Against COVID-19?
An April 2022 poll from the Kaiser Foundation found that about one in five parents (18%) would get their young children vaccinated immediately. A larger number (38%) are waiting for more research, with the remaining parents expressing even more reluctance. “It’s very understandable that parents sometimes are reluctant or want to take a ‘wait-and-see’ approach. Parents naturally and instinctively worry about their children, as I would with my own children,” says Dr. Fauci.
One reason behind the hesitation is that COVID-19 usually presents with mild symptoms in kids, so parents might not think the shots are necessary. But even so, Dr. Fauci says children are “not exempt” from serious complications. Some kids who contract COVID-19 get debilitating long-haul symptoms, for example, while others are diagnosed with a life-threatening complication called multisystem inflammatory syndrome in children (MIS-C). Vaccines can protect against these complications and other serious side effects—some of which might require hospitalization.
The vaccines can also prevent death from COVID-19. “Thus far, there have been over 400 deaths from children within that age group” during the pandemic, Dr. Fauci adds. “If you wait too long, you might miss the opportunity to protect your children.”
When Should Kids Receive the COVID Vaccine?
The COVID-19 vaccine approval coincides with the end of the school year. Parents might wonder if they should vaccinate their children now or wait until classes begin in the fall. The verdict? "There's enough virus dynamic going on right now that you really don't want to wait. I strongly recommend you don't delay because the vaccines are available now and you want to protect your children now," says Dr. Fauci.
It's important to note that you should vaccinate your children even if they've already had COVID-19 because reinfection is possible.
