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April 28, 2022

FDA Mulls COVID Vaccines For Young Kids

FDA Mulls COVID Vaccines For Young Kids

Moderna is seeking emergency use authorization (EUA) of its COVID vaccine for use in children ages 6-months to 5-years old. The long-anticipated move comes nearly three months after Pfizer and BioNTech began their rolling submission to the FDA for authorization of their own mRNA vaccine for kids between 6-months and 4-years old.

Only the Pfizer COVID vaccine is currently authorized for use in kids and teens between 5 and 17-years old. Many parents are anxiously awaiting the FDA’s decision as younger children remain unprotected from the coronavirus as preventative measures are relaxed, millions of Americans resume travel and other activities, and highly contagious variants continue to spread.

“We know parents of children under the age of 5 are eager to provide their kids the protection of a vaccine,” said Jeff Zients, White House COVID-⁠19 response coordinator, during a March 2 press briefing. “The President’s plan ensures that as soon as a vaccine is authorized, we’ll be ready with plenty of vaccines and prepared to help parents vaccinate their youngest kids at thousands of trusted and convenient locations across the country.”

But it may be June before either vaccine gets a green light. The Pfizer and Moderna vaccines for younger children are slightly different doses and regimens, which require extra scrutiny by regulatory officials, Anthony Fauci, MD, President Biden’s chief medical advisor, explained to CNN.

How the vaccines differ
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. Pfizer’s data on the third dose given at least 8 weeks after completion of the second dose is being provided to regulatory officials on a rolling basis, or as it becomes 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. The results also found the vaccine held up against the highly contagious 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 2 and 5-years old, which is similar to efficacy rates against Omicron among adults.

Pediatric infections and hospitalizations have spiked
Reported COVID cases among children surged during the winter Omicron wave, reaching a weekly high of 1,150,000 new infections. For the week ending April 21, more than 37,000 more infections have been reported, a 43 percent jump from the previous seven days, according to the American Academy of Pediatrics (AAP).

As of April 21, 12.9 million children have tested positive for COVID-19 since the pandemic began. Of these, nearly 7.9 million have been reported since September 2021, the AAP points out. Children now account for 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 were hospitalized with the disease 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.

Children 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 7,880 cases of MIS-C have been reported as of March 28, and of these cases, 66 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-19, about one-third of kids hospitalized due to COVID 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.

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.

What happens now
If both vaccines are authorized by the FDA, all kids ages 6-months and older would be eligible for either the Pfizer or Moderna COVID vaccine. But the U.S. Centers for Disease Control and Prevention (CDC) must approve the FDA’s decision before children between 6-months and 4-years old could start receiving their shots.

If just one of the vaccines is authorized, it would become the first and only vaccine available for children in this younger age group.

In November 2021, the CDC approved the Pfizer-BioNTech COVID-19 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 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.

People ages 12 and older get two 30-microgram doses of the Pfizer vaccine 21 days apart. Like teens and adults, kids ages 5 to 11 are given two doses of the vaccine 21 days apart. But they receive a lower dose of 10-micrograms.