The authorization was based on “thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group,” according to the FDA. The agency gave its go-ahead as research results from 4,500 children ages 5 to 11 showed that the vaccine had an efficacy rate of nearly 91 percent in preventing COVID-19 infection in children who had not previously been infected with COVID-19. As with the Pfizer shots for older people, these kids received two doses, administered three weeks apart. Young people in this age group receive a smaller, 10 microgram (mcg) dose per shot, compared with the 30 mcg dose given to those ages 12 and up.
COVID-19 Can Cause Serious Health Issues for Youngsters
COVID-19 cases in children ages 5 through 11 make up 39 percent of U.S. cases in individuals younger than 18, the FDA reported. Latest figures from the American Academy of Pediatrics (AAP) show that at least 6.3 million children have tested positive for COVID-19 since the onset of the pandemic. Weekly infections among children have averaged more than 100,000 over the past two months, which is “an extremely high number,” according to AAP. The FDA’s advisory committee cited data showing that among all children ages 5 to 11, COVID-19 was one of the top 10 causes of death in the United States over the last year. Since the start of the pandemic, there have been more than 8,300 hospitalizations among children ages 5 to 11, and 745 children younger than 18 have died. Hospitalization rates are three times higher for non-Hispanic Black, non-Hispanic American Indian and Alaskan Native, and Hispanic children compared with non-Hispanic white children. Children can also experience long-haul effects from infection with the virus. A study published August 3 in the Lancet Child & Adolescent Health looked at data from more than a quarter million children in the United Kingdom ages 5 to 17 and found that infection is usually of short duration (about 6 days vs. 11 days in adults), but prolonged illness still occurs in about 4.4 percent. Most common symptoms in this investigation were headache (62 percent) and fatigue (55 percent). This research also noted that during the pandemic, a new rare condition emerged: multisystem inflammatory syndrome in children (MIS-C). With this sometimes lethal condition, different body parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs. “Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said the FDA’s acting commissioner, Janet Woodcock, MD. “With authorization from the FDA, parents can now feel confident in vaccinating their children, and collectively breathe a sigh of relief,” says Robert Glatter, MD, a physician in the department of emergency medicine at Lenox Hill Hospital in New York City. “The rigorous review of studies involving thousands of children, and the unanimous approval by the committee, indicate the highest level of confidence to parents of the benefits outweighing any potential risks, such as myocarditis [heart inflammation] associated with vaccination."
What Comes Next in the Authorization Process
The Centers for Disease Control and Prevention’s Advisory Committee on Immunizaton Practices is due to meet Tuesday, November 2, to weigh in on the shots. Following the committee’s recommendations, the CDC’s director, Rochelle Walensky, MD, MPH, will give her opinion on the kids’ vaccine, which is expected to officially open the doors to distribution. The Biden administration has procured enough vaccine to inoculate the country’s 28 million children ages 5 to 11 years old, and is ready to ship out doses immediately to tens of thousands of pediatricians, family doctors, children’s hospitals, community health centers, rural health clinics, and pharmacies. “We will be ready immediately following the FDA and CDC’s decisions so that parents can get their kids vaccinated quickly, easily, and conveniently,” said Jeffrey Zients, the White House’s COVID-19 response coordinator, in a press briefing.
More Children’s Vaccines on the Way
Other children’s vaccines are progressing. On October 25, Moderna shared study data based on 4,700 participants showing that two doses of its vaccine given 28 days apart produced a strong neutralizing antibody response in children ages 6 to 11. The shots were given at 50 mcg — half that of the normal adult shot. Johnson & Johnson is also expected to begin vaccine trials. The vaccine for young children taken longer to arrive because clinical trials with children had to be carefully designed and conducted, and the FDA needed time to thoroughly review the study data, the vaccine expert Paul Offit, MD, told The New York Times.
But How Many Parents Will Get Their Kids Vaccinated?
How many parents will decide to vaccinate their young children is uncertain. A recent Kaiser Family Foundation survey among 1,519 adults found that about 3 in 10 parents of 5- to 11-year-olds (27 percent) are eager to get a vaccine for their younger child as soon as one is authorized; a third say they will wait a while to see how the vaccine is working. Three in 10 parents say they will definitely not get the vaccine for their 12- to 17-year-old (31 percent) or their 5- to 11-year-old (30 percent).
