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The vaccine could already be available next week for this age group. The US Drug Administration (FDA) is not required to follow the expert committee’s recommendation, but it usually does. If the FDA approves the vaccine for children ages 5 to 11, some 28 million children may be eligible for Covid-19 vaccination.
In the United States, the way is paved toward vaccinating children ages 5 to 11. This Tuesday, an expert panel made up of independent scientists (immunologists, experts in infectious diseases, pediatricians, etc.), ruled in favor of the authorization of the Pfizer-BioNTech vaccine against Covid-19, for minors in this group old.
Before giving the green light to the directive, the experts reviewed the data presented by Pfizer and the health authorities. After a day of debates broadcast online, its members estimated with 17 votes in favor and one abstention that the benefits of the vaccine for children outweigh the risks.
Although children who become seriously ill or die from Covid-19 are relatively few compared to adults, some develop complications and infections in this group have increased due to the more easily transmitted Delta variant of the coronavirus.
The data of the American Academy of Pediatrics show that more than 500 American children have died from Covid-19.
In support of their request, Pfizer presented the results of a clinical trial that demonstrated a 90.7% efficacy of the vaccine in preventing symptomatic forms of the disease.
“Vaccination will help ensure face-to-face learning” in school, which is “crucial for the development of children,” argued William Gruber, head of Pfizer. In addition, children “play an important role in the transmission” of the virus in the general population, he added.
Debate on cases of myocarditis, a heart condition
The main point of debate was around the risk of myocarditis caused by the vaccine. This inflammation of the heart muscle is a side effect that has been seen especially in adolescents and young adults (mainly males) after being vaccinated with Pfizer or Moderna.
The health authorities have confirmed about 880 cases of which about 830 have required hospitalization. Since then, some 790 have returned to their homes and no deaths have been recorded.
Among the total of 3,000 children vaccinated during Pfizer’s clinical trials, no cases of myocarditis were detected. Experts believe that this side effect should be even more rare in young children, as it may be related to testosterone levels. However, this does not mean that risk is absent.
But despite this, the FDA analysis predicted that the number of “clinically significant problems” related to Covid-19 and prevented by the vaccine “would exceed the cases of myocarditis.”
The vaccine expert at the Children’s Hospital of Philadelphia, Paul Offit, expressed his reservations.
“I think that for me, it is always stressful that we are asked to make a decision for millions of children based on studies done only on a few thousand children,” he said.
Lower doses for children
But Offit was also more composed because the dose for children will be lower: ten micrograms per injection instead of thirty for the older age groups. However, many experts consider the issue difficult to resolve and stress the need to monitor the data after the vaccination campaign begins.
Once approved by the FDA, a group of experts from the Centers for Disease Control and Prevention (CDC) will meet on November 2-3 to discuss the matter. The federal agency will then publish its recommendations for healthcare professionals who will administer the doses. As in the case of adults and adolescents, the vaccine requires two injections, three weeks apart.
The White House has said it is prepared to send millions of doses to every corner of the country. Children can be vaccinated in pediatrician offices, in pharmacies and in some schools.
However, it is still necessary to convince the parents. According to a survey by the Kaiser Family Foundation held at the end of September, about a third of them stated that they would vaccinate their children as soon as possible, another third said they would wait before making a decision and a quarter said they would not vaccinate them.
In the world, only a few other countries, such as China, Cuba and the United Arab Emirates, have so far authorized Covid-19 vaccines for children in this age group.
AFP and EFE
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