United States: FDA Approves Pfizer Vaccine for Children 5-11 Years.

source: www.nature.com

The Food and Drug Administration gave the green light to vaccinate 28 million minors. If CDC gives final approval, they will begin inoculating them on Wednesday.

TODAY, the U.S. Food and Drug Administration (FDA) authorized Pfizer-BioNTech's coronavirus vaccine for emergency use in children ages 5 to 11.

This is a measure that raises excellent expectations for millions of families seeking to protect some of the only Americans left to be vaccinated: approximately 28 million children in this group would be eligible to receive the pediatric dose of Pfizer, which contains a third of the one applied to adults, with two injections three weeks apart.

"As a mother and as a physician, I know that parents, caregivers, school personnel, and children have been waiting for clearance today," FDA Acting Director Janet Woodcock said in a statement. "Vaccinating younger children against COVID-19 will bring us closer to getting back to normal."

After this step, now it will be the turn of the Centers for Disease Control and Prevention (CDC) to give the final green light to the measure. With this latest approval, expected in the next few days, children ages 5 to 11 in the United States could begin getting vaccinated on Wednesday, November 3. The first children would be fully protected at Christmas.

On October 26, a U.S. government medical advisory panel voted to recommend the Pfizer COVID-19 vaccine authorization for children ages 5 to 11.

"It's pretty clear to me that the benefits outweigh the risk when I hear about children being admitted to the ICU, having long-term outcomes after their covid, and children dying," said Amanda Cohn of the CDC, who voted in favor. There were 17 votes in favor and one abstention.

A study of elementary school children found that Pfizer vaccines prevent symptomatic infection in 91% of cases. However, it is one-third of the dose that adolescents and adults receive.

FDA officials said the protection would "far outweigh" the risk of a very unusual side effect in almost all pandemic scenarios in a preliminary analysis last week.

While the risk of severe COVID-19 is lower in children than in adults, there have been cases among those aged five to 11 years, with more than 8,300 hospitalizations, a third of which required intensive care. And nearly 100 deaths, FDA vaccine chief Dr. Peter Marks told the advisory panel.

"The infections have caused the closure of many schools and disrupted the education and socialization of children," he added.

"I want to acknowledge the fact that there are strong feelings" in public for and against vaccination, Marks said. However, he added that the discussion would be on scientific data, "not on vaccination orders, which correspond to other agencies outside the FDA."

States are preparing to distribute the vaccines - in vials with an orange cap to distinguish them from adult doses - as soon as the government gives the green light. In addition, more than 25,000 pediatricians and other primary care providers have declared themselves vaccine providers