Europe 1 with AFP 9:37 p.m., October 29, 2021, modified at 9:38 p.m., October 29, 2021
As expected, the US Medicines Agency has given the green light to the vaccination of 5-11 year olds against the coronavirus with the product developed by the Pfizer and BioNTech laboratories.
A decision that affects some 28 million Americans.
The United States on Friday authorized Pfizer-BioNTech's Covid-19 vaccine for 5 to 11 year olds, paving the way for the imminent launch of a new major stage of the immunization campaign, which concerns 28 million children in the country.
"An additional step towards a return to normalcy"
This emergency clearance from the US Medicines Agency (FDA) was granted after careful review of the results of clinical trials conducted by Pfizer on several thousand children. "As a mother and physician, I know that parents, caregivers, teachers and children have been eagerly awaiting this clearance," Janet Woodcock, acting commissioner of the FDA, said in a statement. "Vaccinating young children against Covid-19 is an additional step towards a return to normalcy," she insisted.
On Tuesday, a committee of independent experts met, and after a day of discussions, was in favor of immunization of 5-11 year olds with this vaccine.
According to clinical trials, the remedy has been shown to be 90.7% effective in preventing symptomatic forms of the disease in this age group.
Before the injections begin, a committee of experts from the Centers for Disease Prevention and Control (CDC) is in turn to meet early next week to deliver its opinion.
This federal public health agency will then publish its recommendations, the final step in the process.
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A lower dosage
The vaccine dosage was adjusted to 10 micrograms per injection (two in number, administered three weeks apart), compared to 30 micrograms for the older groups. The caps of the vials intended for children will be orange, and thus easily recognizable compared to the purple caps of the vials for the older age groups. White House Pandemic Coordinator Jeff Zients on Wednesday said the government stood ready, as soon as FDA clearance was announced, to "immediately send millions of doses" to all corners of the country. , "to tens of thousands of pediatricians, family doctors, children's hospitals, health centers, rural clinics and pharmacies".
The recommendations of the FDA are often referred to around the world.
The European Medicines Agency is also reviewing an application for authorization of Pfizer's vaccine for this age group.