The announcement concerns 28 million children in the United States. The country authorized, Friday, October 29, Pfizer-BioNTech’s vaccine against Covid-19 for 5 to 11 year olds, paving the way for the imminent launch of a new major stage of the immunization campaign. This emergency clearance from the Food and Drug Administration (FDA), the US drug agency, was granted after careful review of the results of clinical trials conducted by Pfizer on several thousand children.
“As a mother and a doctor, I know that parents, caregivers, teachers and children have been eagerly awaiting this authorization.”, said Janet Woodcock, acting commissioner of the FDA. “Vaccinating young children against Covid-19 is an additional step towards a return to normalcy”, she insisted.
Composed of independent scientists (immunologists, experts in infectious diseases, pediatrics, etc.), the committee reviewed the data gathered by Pfizer and the health authorities. Its members estimated that the benefits of the vaccine for children aged 5 to 11 outweighed the risks (17 votes and one abstention).
Debate on the risk of myocarditis
Children “Are far from being spared the damage from Covid-19”, recalled Peter Marks, of the FDA, in the introduction. Since the start of the epidemic in the United States, more than 1.9 million cases of Covid-19, more than 8,300 hospitalizations and a hundred deaths have been recorded among this category of the population (5-11 years) , he detailed. Children catching the virus may develop pediatric multisystem inflammatory syndrome or “Covid long”.
To support its request for authorization, Pfizer presented the results of a clinical trial that demonstrated a 90.7% efficacy of the vaccine in preventing symptomatic forms of the disease in children aged 5 to 11. The main point of debate concerned the risk of myocarditis caused by the product. This inflammation of the heart muscle is a side effect that has been detected in adolescents and young adults in particular. It caused 830 hospitalizations, but no deaths in the United States, and no cases were detected in clinical tests of Pfizer.
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.
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 on vials intended for children will be orange and thus easily recognizable compared to the purple caps on vials for older groups.
Once the vaccine is authorized, 15 million doses will be immediately distributed across the country, where vaccination, already possible for those over 12, should facilitate a return to normal in schools. More than 2,000 schools (hosting more than one million students) were forced to close between August and October due to the Covid-19 epidemic. According to CDC virologist Fiona Havers, cited by the New York Times, the hospitalization rate for 5-11 year olds is three times higher for black, Hispanic or Native American children than for white children.