Updated on June 18, 2022.
Young kids can start receiving COVID vaccines. The Centers for Disease Control and Prevention (CDC) accepted the Advisory Committee on Immunization Practices’ (ACIP) recommendation that children ages 6 months and older should be vaccinated against COVID. This follows the decision by the Food and Drug Administration (FDA) to authorize both mRNA vaccines—Pfizer and Moderna—for children as young as 6-months old.
The FDA's decision gives Moderna emergency use authorization (EUA) of its COVID vaccine for use in children ages 6 months to 5 years old. Pfizer’s low-dose COVID vaccine is also authorized for emergency use among kids between 6 months and 4 years old. Now that the CDC has approved the FDA's decision, this younger age group can start receiving their shots.
The long-anticipated move comes two months after Moderna submitted its data to the FDA and roughly five months after Pfizer and BioNTech began their rolling submission to U.S. regulatory officials.
Three doses of Pfizer-BioNTech’s Covid-19 vaccine for the youngest children were 80 percent effective against the omicron variant of the coronavirus, according to early data the company released on May 23.
Moderna’s latest trial data also showed two doses its vaccine produced “a robust neutralizing antibody response” among kids as young as 6 months old, with no serious safety concerns. Like Pfizer, the Moderna vaccine held up against the Omicron variant, with an efficacy rate of 50 percent for babies and toddlers up to 2 years old. It was also 37 percent effective for kids between the ages of 2 and 4, which is similar to efficacy rates against Omicron among adults.
How the vaccines differ
Until early June 2022, only the Pfizer COVID vaccine was authorized for use in kids and teens between 5 and 17 years old. Parents of younger children anxiously awaited the FDA’s decision as this age group was unprotected from COVID as preventative measures were relaxed, millions of Americans resumed travel and other activities, and highly contagious variants continued to spread.
Why did it take so long? The Pfizer and Moderna vaccines for younger children are slightly different doses and regimens, which required extra scrutiny by regulatory officials, Anthony Fauci, MD, President Biden’s chief medical advisor, explained to CNN.
In February, Pfizer asked the FDA to authorize the first two doses of a planned three-dose primary series for this younger age group. The move was intended to potentially allow these children to start receiving their shots while research on the safety and efficacy of an additional third dose continued.
People ages 12 and older get two 30-microgram doses of the Pfizer vaccine 21 days apart. Kids ages 5 to 11 are also given two doses of the vaccine 21 days apart, but they receive a lower dose of 10-micrograms.
Children age 6 months to 4 years old will receive an even lower three-microgram dose, given in three shots. The first two doses are given three weeks apart, followed by a third dose at least two months later. Data on the third dose was provided to regulatory officials on a rolling basis, or as it became available.
Initial trial results released in December showed two 3-microgram doses of the vaccine safely generated protection in children up to 2-years old. And although they were safe among kids ages 2 to 4, the two doses were less effective for these preschool-age children. At the time, Pfizer announced a third dose would be added to its trials in order to achieve high levels of protection against current and potential future variants.
By comparison, Moderna’s COVID vaccine for children ages 6 months to 5 years old includes two shots—not three. And each of these shots contains a larger, 25-microgram dose.
The company released its latest trial data, which showed “a robust neutralizing antibody response” among kids as young as 6 months old, and no serious safety concerns.
Pediatric infections and hospitalizations have spiked
Reported COVID cases among children surged during the winter 2022 Omicron wave, reaching a weekly high of 1,150,000 new infections. For the week ending June 2, more than 87,000 child COVID cases were reported, which is the first weekly decline in pediatric cases since early April, according to the American Academy of Pediatrics (AAP).
Nearly 13.5 million children have tested positive for COVID since the pandemic began, the AAP reports. Of these cases, 5.6 million were confirmed in 2022, and more than 400,000 were identified in the past month.
Children now account for about 19 percent of all U.S. COVID cases even though they make up just 22.2 percent of the population.
Pediatric cases are typically milder than adults but hospitalizations among children have increased. Nearly 103,000 children and teens with the disease were admitted to the hospital between August 1, 2020 and January 29, 2022, the CDC reports.
Children are also much less likely to die from COVID than adults, but the disease has already claimed the lives of nearly 1,200 U.S. kids and teens.
The CDC cautions that having COVID could increase the risk for diabetes in people who do not already have the condition—even kids. A January 14 CDC report revealed that people younger than 18-years old with COVID-19 are 166 percent more likely to be newly diagnosed with diabetes more than 30 days after their infection than those without COVID and those who had acute respiratory infections before the pandemic began.
Young people are also at risk for certain COVID-related complications, including multisystem inflammatory syndrome, or MIS-C. Although still very rare, the CDC reports that at least 8,525 cases of MIS-C have been reported as of May 31, and of these cases, 69 were fatal. The CDC points out the median age of these patients was 9-years old and 98 percent of them tested positive for COVID. The other 2 percent had contact with someone who was infected.
Researchers point out that pericarditis (inflammation of the outer lining of the heart) or myocarditis (inflammation of the heart muscle), which may also be concerns among those who are hesitant to vaccinate, are more likely to develop due to MIS-C or COVID infection than vaccination.
And while underlying health issues, such as diabetes and obesity, are tied to more severe COVID, about one-third of kids hospitalized do not have a preexisting condition. CDC data also shows that only 0.4 percent of kids that were hospitalized for COVID and eligible for the COVID vaccine were fully vaccinated.
In November 2021, the CDC approved the Pfizer COVID vaccine for children ages 5 to 11-years old, following the unanimous recommendation of its Advisory Committee on Immunization Practices (ACIP). The decision was based on trial data, which showed the vaccine is safe and nearly 91 percent effective against symptomatic COVID in this age group. The Pfizer vaccine is also FDA-approved for use in people ages 16-years and older and is also available under emergency use authorization (EUA) for kids and teens between 12 and 15-years old. The latest CDC data available on teens shows that among those ages 12 to 18-years old, two doses of the Pfizer vaccine were 93 percent effective in preventing hospitalizations due to COVID.
Federal regulators have also authorized the Modern COVID vaccine for emergency use among kids and teens ages 6 to 17. Results of Moderna’s late-stage trails found its vaccine had an efficacy rate of about 77 percent for kids between 6 and 11 years old. The vaccine also had an efficacy rate of about 93 percent for those between 12 and 17 years old. Older teens receive the same 100-microgram dose per shot as adults. Younger kids age 6 to 11 receive two 50-microgram doses, and kids age 5 and younger receive 25-microgram doses. The second shot is given one month after the first.
