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  • The Food and Drug Administration authorized a lower-dose COVID-19 vaccine for children 5 to 11 years old.
  • Children in this age range are at lower risk from COVID-19 than adults, but more than 1.9 million children in this age group have developed COVID-19 in the United States.
  • COVID-19 is a top 10 cause of death in this age range.

On Oct. 29, the Food and Drug Administration (FDA) authorized the use of the Pfizer-BioNTech pediatric COVID-19 vaccine for 5- to 11-year-olds.

The agency said that its decision was based on data from a clinical trial showing that this lower-dose vaccine was 90.7 percent effective in preventing COVID-19 in this age group.

In addition, no serious side effects were detected in the 3,100 children who received the vaccine during the study.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization,” said acting FDA Commissioner Dr. Janet Woodcock in a statement. “Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy.”

Woodcock went on to say that the FDA’s review of the clinical trial data “should help assure parents and guardians that this vaccine meets our high standards.”

A vaccine advisory committee for the Centers for Disease Control and Prevention (CDC) will meet on Nov. 2 to decide which children would benefit most from the vaccine. The CDC will then issue its own recommendation.

If both of these steps go well, children could begin receiving the vaccine at the end of the first week of November.

The FDA’s decision comes after a panel of independent scientists voted Oct. 26 in support of the authorization.

School-aged children are at lower risk from COVID-19 than adults.

However, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at the FDA advisory group meeting on Oct. 26 that children ages 5 to 11 are “far from being spared from the harm of COVID-19.”

To date, there have been more than 1.9 million coronavirus cases among this age group, said Marks.

Also, more than 8,300 younger children have been hospitalized due to COVID-19, with about a third of those needing intensive care.

“There have also been close to 100 [COVID-19] deaths, making it one of the top 10 causes of death in this age range,” Marks said.

Dr. Fiona Havers, a medical officer for the CDC, said during the meeting that COVID-19 has impacted certain groups of children more than others, similar to patterns seen in adults.

Hospitalization rates among this age group are three times higher for Black, Hispanic, American Indian, and Alaska Native children compared with white children, she said.

In addition, COVID-19 has disrupted children’s education throughout the pandemic.

CDC data shows that “more than 2,000 schools had unplanned closures [due to COVID-19], impacting more than a million students,” Havers said.

The final vote of the FDA’s expert panel was 17-to-0 in favor, with one member abstaining.

The dose for the Pfizer-BioNTech pediatric vaccine would be one-third of the strength of the dose given to people 12 and older, with two doses given 3 weeks apart.

The vaccine will be shipped in vials with different colored caps with clear labeling and instructions to distinguish them from the already authorized vaccine doses for adolescents and adults.

Even with its lower-strength dose, the pediatric vaccine was more than 90 percent effective against infection, according to data presented at the meeting.

Side effects were similar to what was seen in older children and adolescents. Pain at the injection site, fatigue, and headache were among the most common side effects.

No serious side effects related to the vaccine occurred in children who were vaccinated.

At the FDA advisory panel meeting, CDC scientists presented several scenarios that looked at the risks and benefits of the vaccine, based on varying levels of virus transmission, rates of possible side effects, and vaccine effectiveness.

They found that the benefits of the vaccine for younger children generally outweighed the risks of side effects.

The main risk looked at was rare cases of heart inflammation — myocarditis and pericarditis — after vaccination, which is primarily seen in older male adolescents and young adult males after the second dose.

These heart conditions can also occur after coronavirus infection or other viral or bacterial infections. Myocarditis after COVID-19 can be more severe than what occurs after vaccination.

In the risk-benefit models presented at the meeting, CDC scientists based the risk of myocarditis after vaccination on rates seen in adolescents.

Some committee members pointed out that pre-COVID-19 myocarditis rates in younger children are lower than in adolescents. A similar trend may be seen with myocarditis after vaccination, they said.

Given the low but very real risk of myocarditis in children after vaccination, several committee members questioned whether the vaccine should be authorized for the entire age group or those most at risk.

In the end, the committee voted to let parents — in conjunction with their pediatrician — make an informed decision for their child.

Children with underlying medical conditions have a higher risk of ending up in the hospital or ICU with COVID-19, so for them, vaccination may make more sense.

Likewise, Black, Hispanic, American Indian, and Alaska Native children are at higher risk of severe COVID-19, which may factor into parents’ decisions about vaccination.

“I want to make sure that the children who really need this vaccine — primarily the Black and Brown children in our country — get the vaccine,” said committee member Dr. James Hildreth, a professor of internal medicine at Meharry Medical College.

“But to be honest, the best way to protect the health of some kids would be to do nothing at all, because they’re going to be just fine,” he said.

The CDC’s Dr. Amanda Cohn said that the CDC and FDA will continue to monitor the safety of this vaccine using several systems, some of which provide real-time reporting.

This will provide a better understanding of the risk of myocarditis after vaccination in younger children, which will help inform parents’ decisions about whether to have their child vaccinated.

Cohn acknowledged the potential myocarditis risk after vaccination, but pointed out that most cases have been mild, and patients have responded well to treatment.

In contrast, “COVID is also the eighth-highest killer of kids in this age group,” she said. “The use of this vaccine will prevent deaths, will prevent ICU admissions, and will prevent significant long-term adverse outcomes in children.”