This authorization opens the way to the imminent launch of a new step in the immunization campaign, which concerns 28 million children in the country.
Le Monde with AFP
The announcement concerns 28 million children in the United States. The country authorized, Friday, October 29, the Pfizer-Biontech vaccine against CVIV-19 for the 5 to 11 years, paving the way for the imminent launch of a new step in the immunization campaign. This emergency authorization from the Food and Drug Administration (FDA), the US Medicines Agency, has been granted after the Pfizer clinical trial results in several thousand children.
“As a mother and doctor, I know that parents, caregivers, the faculty and the children were waiting for this authorization impatience,” greeted in a statement Janet Woodcock, Acting Commissioner of the FDA. “Vaccinate young children against COVID-19 is an extra step towards a return to normal,” she insisted.
Composed of independent scientists (immunologists, infectious disease experts, pediatrics …), the Committee reviewed the data gathered by Pfizer and the health authorities. Its members felt that the profits of the vaccine for children aged 5 to 11 took over the risks (17 votes and an abstention).
Debate on the risk of myocarditis
Children “are far from being spared by the damage of COVID-19,” said Peter Marks, from the FDA, in the introduction. 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 a hundred deaths have been recorded among this category of the population (5-11 years) He detailed. Children caught the virus can develop a pediatric multisysthetic inflammatory syndrome or a “long Covid”.
To support its application for authorization, Pfizer had presented the results of a clinical trial that demonstrated a 90.7% efficiency of the vaccine to prevent the symptomatic forms of the disease among 5 to 11 years old. The main point of debate concerned the risk of myocarditis caused by the product. This inflammation of cardiac muscle is a side effect that has been detected in particular in adolescents and young adults. It caused 830 hospitalizations, but no deaths in the United States, and no cases were detected in the clinical tests of Pfizer.
Before injections begin, an expert committee of prevention and disease control centers (CDC) must in turn meet early next week to make its opinion. This federal public health agency will then publish its recommendations, ultimate step of the process.
The dosage of the vaccine has been adapted to 10 micrograms per injection (two, administered at three weeks apart), against 30 micrograms for older groups. The bottle cap for children will be orange and thus easily recognizable compared to the purple caps of the bottles for older groups.
Once the vaccine is allowed, 15 million doses will be immediately distributed across the country, where vaccination, already possible for more than 12 years, should facilitate the return to normal in schools. More than 2,000 institutions (welcoming more than one million students) were forced to close between August and October due to the CIVID-19 epidemic. According to Fiona Havers, Virologue to CDC, cited by the New York Times, the 5-11 year hospitalization rate is three times higher for black, Hispanic or Native American children as for white children.