The announcement involves 28 million children in the United States. The country approved Pfizer’s BioNTech Covid-19 vaccine for children aged 5 to 11 on Friday, October 29, paving the way for a new major phase of the upcoming immunization campaign. After carefully reviewing the results of Pfizer’s clinical trials on thousands of children, the U.S. Drug Administration’s Food and Drug Administration (FDA) granted this emergency clearance.
“As a mother and doctor, I know that parents, caregivers, teachers and children have been eagerly waiting for this authorization.”Said Janet Woodcock, acting commissioner of the US Food and Drug Administration. “Vaccinating young children with the Covid-19 vaccine is another step to return to normal”, She insisted.
The committee is composed of independent scientists (immunologists, infectious disease experts, pediatric experts, etc.) and reviewed data collected by Pfizer and health authorities. Its members estimated that the benefits of vaccines for children aged 5 to 11 outweigh the risks (17 votes and 1 abstention).
Controversy about the risk of myocarditis
children “Far from the harm of Covid-19”, Recalled FDA’s Peter Marks (Peter Marks) in the introduction. He detailed that since the beginning of the epidemic in the United States, more than 1.9 million cases of Covid-19, more than 8,300 hospitalizations and 100 deaths have been recorded in this group of people (5-11 years old).Children infected with the virus may develop pediatric multisystem inflammatory syndrome or “Covid Long”.
In support of its request for authorization, Pfizer announced the results of a clinical trial that showed that the vaccine is 90.7% effective in preventing symptomatic forms of disease in children between 5 and 11 years of age. The main point of contention is the risk of myocarditis caused by this product. This myocardial inflammation is a side effect, especially found in teenagers and young adults. It resulted in 830 hospitalizations, but there were no deaths in the United States, and Pfizer’s clinical trials did not find cases.
Before the injection begins, an expert committee of the Centers for Disease Control and Prevention (CDC) will meet early next week to give opinions. The federal public health agency will then issue its recommendations, which is the last step in the process.
The vaccine dose was adjusted to 10 micrograms per injection (two times, three weeks apart), compared to 30 micrograms in the older group. The caps of medicine bottles for children will be orange, so they are easier to identify than the purple caps used for medicine bottles for older age groups.
Once the vaccine is approved, 15 million doses of the vaccine will be distributed across the country immediately. The vaccination that can be carried out for more than 12 seconds should help the school to return to normal. Due to the Covid-19 epidemic, more than 2,000 schools (accommodating more than 1 million students) were forced to close between August and October. According to CDC virologist Fiona Havers, New York TimesThe hospitalization rate for children aged 5-11 is three times that of black, Hispanic, or Native American children, and three times that of white children.