WASHINGTON — Regulators at the U.S. Food and Drug Administration on Friday granted emergency authorization to Pfizer’s COVID-19 vaccine for 5- to 11-year-olds, a step that means kid-sized doses can begin shipping to health care providers across the country.
Vials of the two-shot vaccine will be headed to pediatricians’ offices, hospitals, pharmacies and other providers, so they can be deployed as soon as the Centers for Disease Control and Prevention gives its sign off.
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The CDC’s panel of vaccine experts is scheduled to meet Tuesday to discuss guidelines for the vaccine’s use in the younger age group.
Some 28 million U.S. kids are poised to become eligible for a COVID-19 vaccine, which would offer them significant protection against the disease that has disrupted three separate school years and so many other aspects of children’s lives.
While kids have been at lower risk of infection and severe complications from the virus, the nearly 100 deaths among 5- to 11-year-olds mean it is one of the top 10 causes of death for that age group. Infections among children also have risen amid the summer surge from the delta variant.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization,” acting FDA Commissioner Janet Woodcock said in a news release announcing the shot’s authorization. “Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy.”
As with Pfizer’s shot for teens and adults, the version for children also requires two doses spaced three weeks apart. The dosage for the younger age group is much smaller: 10 micrograms for kids, compared to 30 micrograms for adults.
Data from Pfizer that was analyzed by FDA regulators indicates that the company’s vaccine would offer strong protection. The two-shot regimen had a 90.7% efficacy rate in preventing symptomatic COVID-19 in a clinical trial of children ages 5 to 11, with similar side effects to those in adults, such as headache and fever.
While millions of parents have been eagerly awaiting a vaccine option for their children, health care providers and public officials urging vaccination are likely to encounter greater hesitancy as COVID-19 shots become available to those under age 12.
About 3 in 10 parents, or 27%, say they will vaccinate their 5-11 year old child “right away” once a vaccine is authorized for their age group, according to the latest tracking data from the Kaiser Family Foundation.
One-third of parents say they will wait and see how the vaccine is working before seeking an appointment for their child, while another 3 in 10 say they definitely won’t get their 5- to 11-year-old inoculated against COVID-19.
The most common concerns cited by parents in that KFF survey were related to safety: More than 7 in 10 said they were concerned about the long-term effects of such a new vaccine, or that their child may experience severe, short-term side effects from the shot.
The Biden administration’s COVID-19 advisers say they will be launching a comprehensive effort to encourage vaccinations in the new age group, with a paid media campaign and a network of trusted local leaders who they hope will be able to sway skeptics.
“We will be ready to answer questions and build confidence through local efforts and national efforts,” said Jeff Zients, White House coronavirus response coordinator. “The bottom line is, we expect more and more kids to get vaccinated across time.”
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