It is an opinion which paves the way for the vaccination of the youngest across the Atlantic. A committee of American experts voted on Tuesday, October 26, in favor of the authorization of Pfizer-BioNTech’s Covid-19 vaccine for children aged 5 to 11.
The advice of this committee is only advisory, but it is rare that it is not followed by the United States Medicines Agency (FDA). If it does allow the vaccine for this age group, then some 28 million children will be eligible in the United States.
Composed of independent scientists (immunologists, experts in infectious diseases, pediatrics, etc.), the committee reviewed the data gathered by Pfizer and the health authorities. At the end of a day of discussions, broadcast live on the Internet, its members estimated that the benefits of the vaccine for children aged 5 to 11 outweighed the risks (17 votes for one abstention).
Children “Are far from being spared the damage from Covid-19”, recalled Peter Marks, of the FDA, in the introduction. Among 5 to 11 year olds, more than 1.9 million cases of Covid-19 have been recorded since the start of the epidemic in the United States, more than 8,300 hospitalizations and a hundred deaths, he said. detailed. Children catching the virus may develop pediatric multisystem inflammatory syndrome (MIS-C), or even « Covid long ».
To support its request for authorization, Pfizer presented the results of a clinical trial that demonstrated the vaccine’s 90.7% efficacy in preventing symptomatic forms of the disease in children aged 5 to 11.
“Vaccination will help ensure in-person learning” at school, “Crucial for the development of children”, argued William Gruber, manager at Pfizer. In addition, children “Play an important role in transmission” of the virus in the general population, he added.
Debate on myocarditis cases
Prior to the meeting, the FDA had released its own interpretation of the data, clearly pointing in favor of authorization.
The main point of debate concerns the risk of vaccine-induced myocarditis. This inflammation of the heart muscle is a side effect that has been particularly detected in adolescents and young adults (especially men) after Pfizer or Moderna. Health authorities have confirmed nearly 880 cases (more than 600 remain to be assessed), of which around 830 required hospitalization. About 790 have since returned home, and no deaths have been recorded.
Among the 3,000 children vaccinated in total during Pfizer’s clinical trials, no cases of myocarditis were detected. Experts believe this side effect should be rarer in young children, as it could be linked to testosterone levels. This does not mean that the risk is absent. But the FDA analysis predicts that the number “Clinically significant problems” linked to Covid-19 prevented thanks to the vaccine “Would clearly offset the excess cases of myocarditis”.
Lower dosage for children
The Dr Paul Offit, member of the committee, said he was reassured by the fact that the dosage for children is lower (ten micrograms per injection instead of thirty for the older groups). Many experts, however, felt the issue was difficult to decide and stressed the need to monitor the data once the immunization campaign has started.
When the FDA gives the green light, a committee of experts from the Centers for Disease Prevention and Control (CDC) will in turn meet on November 2 and 3 on the subject. This federal agency will then publish its recommendations for healthcare professionals administering the doses. As with adults and adolescents, the vaccine requires two injections, three weeks apart. 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.
The White House has said it is ready to send millions of doses to the four corners of the country. Children can be vaccinated by pediatricians, pharmacies or some schools.
But it will still be necessary to convince. According to a Kaiser Family Foundation survey at the end of September, about a third of parents said they would vaccinate their child as soon as possible, another third that they would wait before making a decision and a quarter that they would not have them vaccinated. .
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Covid-19: American committee recommends Pfizer’s vaccine for 5-11 year olds