The United States on Friday authorized the Pfizer COVID vaccine for children aged five-to-11, paving the way for 28 million young Americans to soon get immunized.
The decision came after a high-level medical panel advising the government this week endorsed the shots, ruling that the known benefits outweighed the risks of side-effects.
The United States follows only a handful of other countries including China, Chile, Cuba, and the United Arab Emirates that are inoculating younger children with various vaccines.
"As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today's authorization," said acting Food and Drug Administration chief Janet Woodcock in a statement.
"Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy."
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The vaccine rollout should begin in earnest after the Centers for Disease Control and Prevention convenes a panel on Tuesday to further discuss clinical recommendations.
Pfizer and its partner BioNTech announced this week the U.S. government had bought 50 million more doses as it works to protect children, including eventually those under five.
In a clinical trial involving more than 2,000 participants was found to be more than 90% effective at preventing symptomatic disease.
The vaccine's safety was also studied in more than 3,000 children, and no serious side effects have been detected in the ongoing study.
In this age group, the vaccine is given as two shots three weeks apart, dosed at 10 micrograms -- a third what is given to older age groups.
Severe COVID is rarer in children than adults, but far from non-existent.
According to the CDC, there have been 8,300 COVID hospitalizations of children aged five-to-11 since the start of the pandemic, and 146 deaths.
There have also been more than 5,000 pediatric cases of multisystem inflammatory syndrome in children (MIS-C), a rare but highly serious post-viral complication, including 46 deaths.
Ongoing safety monitoring
Health authorities will continue to monitor for potentially highly rare side effects, such as myocarditis and pericarditis (heart inflammation and inflammation around the heart).
The clinical trials were too small to detect these, but the hypothesis is they will be exceedingly rare because the effect is thought linked to testosterone levels.
In male teens and young adults, the most affected group the effects occur mostly after the second dose of an mRNA vaccine at a rate of a few dozens per million. Most of the cases have been fully resolved.
COVID itself can cause more severe forms of myocarditis, potentially more frequently, depending on the level of transmission within a community.
Beyond protecting childrens' own health, epidemiologists think vaccinating this group will help bring an end to disruptions to school and other activities.
But most of the panelists at a meeting of experts called by the FDA on Monday said they would not support mandates in this age group.
Instead, the decision of whether to get vaccinated should depend on factors such as the child's risk factors and should be left to families, they said.
The United States is emerging from its latest coronavirus wave, driven by the Delta-variant. But cases remain high, particularly in colder northern states that are lagging in their vaccination rate.
Almost 58% of the total population is now fully vaccinated.
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