Getting vaccinated against COVID-19 protects against severe illness, hospitalization, and death. But while most Americans are eligible for the shots, children under 5 can’t roll up their sleeves just yet. That’s left many parents frustrated as they wonder how to protect their smallest kids, especially as pandemic safety protocols have eased across the country.
Thankfully, parents might not have to wait too much longer, because Pfizer and Moderna have requested vaccine authorization from the Food and Drug Administration (FDA) for kids under 5 years old. An expert panel from the FDA is meeting on June 15 to discuss the submissions, focusing on the safety and efficiency of the shots. After that, the Centers for Disease Control and Prevention (CDC) must make the final recommendation about the vaccines.
If the vaccines are authorized by the FDA and CDC, they could become available for kids under 5 by June 21, according to Ashish Jha, M.D., MPH, the White House's COVID-19 response coordinator.
As we're waiting for a definitive timeline, parents likely have several questions: Is the vaccine safe? What are the side effects? How do vaccines work for my child's age group, anyway? Here's what you need to know.
COVID-19 Vaccine Timeline for Kids Under 5
Pfizer and Moderna have asked the FDA to authorize vaccines for children ages 5 and under, who aren't yet eligible for the shots. More details should be released in the coming days, but here's a breakdown of the timeline so far.
Pfizer Vaccine (6 Months to 5 Years Old)
In March 2021, Pfizer announced that it would be conducting clinical trials of its vaccine on children aged 6 months through 4 years, giving families hope that a shot was in sight. But in December, the company said that 2- to 4-year-olds hadn't produced a sufficient immune response after receiving two doses of the vaccine (3 micrograms each). Those ages 6 months to 2 years had adequate immunity. Pfizer then began testing a third low-dose shot, given two months after the initial vaccines, to boost effectiveness.
In February 2022, it seemed like the FDA might grant an emergency use authorization for the first two Pfizer doses, knowing the third dose would shore up protection. Some argued that this could have bolstered the immunity of nearly 20 million young American children, who had seen rising hospitalization rates with the advent of new coronavirus variants. But Pfizer decided to postpone its application and wait for data on the three-dose series of the vaccine.
Clinical trial data came a few months later. It demonstrated that three low doses of Pfizer’s vaccine trigger a sufficient immune response in kids. Indeed, preliminary data suggests 80% effectiveness against symptomatic Omicron illness (though these numbers will likely change as more data comes in).
Moderna Vaccine (6 Months to 6 Years Old)
Moderna is also seeking FDA authorization of its vaccine for children 6 months to under 6 years old, given as two low doses of 25 micrograms each. Based on clinical trial data, vaccine efficacy was 51% for those under 2 years old, and 37% for those between 2 and 6 years old. The effectiveness is less than many parents hoped for, but the vaccines are still shown to protect against severe illness, hospitalization, and death. Researchers also reported minimal side effects and no red flags in clinical trials for babies, toddlers, and preschoolers.
Where Can Kids Get Vaccinated?
"We're going to try to make [the vaccine] available in lots of places," says Dr. Jha. This includes community health centers, children's hospitals, rural health clinics, pharmacies, and community organizations. Pediatricians will also be one of the biggest suppliers of vaccines for kids. "A lot of parents will trust their pediatrician or daily practitioners," says Dr. Jha.
On June 9, the Biden Administration outlined plans for vaccine distribution in preparation for the possible approval of Pfizer and Moderna for young kids. States and health care providers will have access to 10 million doses (half Pfizer and half Moderna), with “millions more available in the coming weeks,” according to a White House fact sheet. About 85% of children live within five miles of a vaccination site. Other steps to increase distribution include providing package sizes of 100 doses for smaller and rural practices, as well as encouraging vaccination through government programs like Medicaid and the Women, Infants, and Children (WIC) Program.
Why Do Young Kids Get a Smaller Dose?
Younger children will receive a smaller dose of the vaccine than older kids and adults. The Moderna vaccine is two low doses of 25 micrograms each (one-quarter of the dosage given to adults). The Pfizer vaccine is three doses of 3 micrograms each (about one-tenth of the dosage for adults). What's the decision behind the smaller doses?
“The number one reason is they’re just physically smaller,” says Dr. Jha. “Kids get lower doses of every medicine,” even Tylenol. Experts carefully studied doses during clinical trials, and they determined the smaller amounts are safe and effective for kids.
What Are the Possible Side Effects?
“All vaccines have some side effects,” says Dr. Jha. And while experts are still analyzing data, most young kids appear to experience mild and short-lived symptoms after COVID vaccination—similar to what you’d expect with older kids, adolescents, and adults. The most common complaints include arm soreness, fatigue, low-grade fever, and redness around the injection site. They usually go away within about one day.
Some parents might be concerned about the reports of myocarditis (heart inflammation) after vaccination, usually in males after the second dose. But this complication is exceedingly rare—and there’s actually more risk of developing myocarditis after COVID-19 infection. “Vaccine-induced myocarditis tends to be very mild. Most of those kids do really well and don’t need to be hospitalized,” says Dr. Jha. Plus, clinical trial data hasn’t indicated myocarditis is a problem for kids under 5. Overall, the benefits of vaccination outweigh the minimal risk of myocarditis.
Does The Vaccine Have Any Long-Term Effects?
There’s been plenty of misinformation circulating about long-term effects of the vaccines on kids. For example, some websites falsely claim that vaccines cause infertility or chronic illness—but Dr. Jha says you don’t need to worry. “Every time a vaccine is introduced, there are false rumors. The infertility thing shows up for every vaccine. It’s nonsense,” he says.
Indeed, according to Dr. Jha, vaccine side always effects show up within the first 8 weeks. “The idea that a vaccine would cause a problem 10-15 years down the road doesn’t make sense,” he adds. “I wish misinformation wasn’t out there because it harms and confuses people.”
If parents are looking for even more reassurance, consider this fact: Dr. Jha's three kids (all over 5 years old) are vaccinated and boosted. "If I for half a second was worried about their long-term health, I wouldn't do that to them. I feel very confident and comfortable that these vaccines are exceedingly safe." He adds the vaccine protection is so strong at preventing serious illness that "once my kids were able to get vaccinated, it was a huge sense of relief that I felt."
Why Has Vaccine Approval Taken So Long?
Everyone 5 and up has already gotten the green light for COVID-19 vaccination. Why has it taken longer for the youngest children? "The companies wanted to be really careful about getting the dosing right," explains Dr. Jha. "They also wanted to make sure that kids tolerated it well, and they didn't have serious side effects." He adds: "We want to move fast but we want to get it right."
Adding to the delayed timeline, younger kids were initially excluded from clinical trials, which is nothing out of the ordinary. “When testing vaccines, we usually start with adults and work down to children to establish safety data,” says pediatrician Christine Turley, M.D., vice chair of research at Atrium Health Levine Children’s Hospital in Charlotte, North Carolina. Kids have different bodies than adults, after all, and experts need to know how their immune systems will react to a particular vaccine or dosage before moving forward with it.
Ethical issues also come into play here, because small children can’t fully consent to being vaccinated, or anticipate the outcome. Thanks to their still-developing brains, they have a harder time understanding potential consequences. “We want to make sure there aren’t hidden risks for children,” Dr. Turley explains. “We’re balancing the risks and benefits against what is ethically acceptable.”
The good news is that the FDA compiled enough safety and efficacy data to allow vaccine candidates to progress to pediatric trials. Vaccine manufacturers "start by enrolling older children, then school-aged kids, then toddlers, then infants. That's because the risks for all of those children are different," says Dr. Turley. With each age group, researchers evaluate dosage, frequency, side effects, and more.
Will Young Kids Need a Booster Shot?
When a vaccine is approved for those under 5, will young kids need a booster shot? We simply don’t know the answer to that yet. After the vaccines start rolling out, experts will study protection from each vaccine over time. If they notice waning immunity, like they did with adolescents and adults, they might recommend a booster shot down the line. Only time will tell what will happen.
Should My Children Get Vaccinated Against COVID-19?
Only you can make that decision, but the top health experts say yes. While most kids get mild cases of COVID-19, some have died from the disease, and others have suffered from long COVID or a life-threatening complication called multisystem inflammatory syndrome in children (MIS-C). Kids can also transmit COVID-19 to high-risk family members, who might develop more severe symptoms. Widespread vaccination could help things go back to normal sooner, lessening the physical and mental stress of the pandemic.
"Can COVID still be a problem for kids? The answer, unfortunately, is yes," says Dr. Jha. "We've seen tens of thousands of hospitalizations of children because of COVID. We've seen deaths because of COVID. They're always tragic, but now they're largely preventable." Dr. Jha adds that COVID-19 is just as dangerous as many childhood diseases we vaccinate against, and because the vaccines are safe and effective, it's a "no-brainer" to get kids vaccinated as soon as they're eligible.
Dr. Jha also stresses that kids should get vaccinated even if they've already had COVID-19 because reinfection is possible.
Parents shouldn’t fear FDA-approved vaccines, emphasizes Purvi Parikh, M.D., an allergist and immunologist with the Allergy & Asthma Network and co-investigator on several vaccine trials. Pediatric clinical trial researchers thoroughly examine all aspects of vaccines for kids, and they won’t approve them until they’re absolutely sure of their safety.
Pediatrician Mona Amin, D.O., the mom behind @pedsdoctalk on Instagram, says she’s ready to support an emergency use authorization for a new vaccine. “You can’t argue with science and data and I fully trust this process,” she wrote in a recent newsletter. Her take: Vaccination doesn’t mean everything will return to normal for kids under 5, but it can reduce risks and let families live more safely.
