United States: Experts recommend Pfizer vaccine for children aged 5 to 11

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A committee of American experts spoke out on Tuesday in favor of the immunization of children aged 5 to 11 years with the Covid-19 vaccine from Pfizer-BioNTech, presaging a very imminent authorization of the remedy for some 28 million children in the United States.

The estimated 28 million children in the United States should soon be able to be vaccinated against Covid-19. A panel of experts recommended, Tuesday, October 26, to the US drug regulator to authorize the use of the vaccine developed by Pfizer with BioNTech for children aged 5 to 11 years, considering that the benefits of vaccination were greater at risk.

This advisory is one more step towards the vaccination of approximately 28 million children in the United States, most of them returning to classrooms after the closures caused during the previous school year by the health crisis due to the coronavirus.

The FDA is not forced to follow the opinion of the panel, but has a habit of doing so. If this is the case, a panel of the American Centers for Disease Control and Prevention (CDC) will in turn meet on November 2 and 3 on the subject, and this federal agency will then publish its recommendations for healthcare professionals. administering the doses.

The vaccine could then be available for children as early as next week.

Benefits greater than risks

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 in favor, one abstention).

Children “are far from being spared from the damage of Covid-19,” Peter Marks, of the FDA, recalled 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 pandemic in the United States, more than 8,300 hospitalizations, and a hundred deaths, he said. detailed.

Children catching the virus can develop pediatric multisystem inflammatory syndrome (MIS-C), or even a “long Covid”.

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 children’s development,” argued William Gruber, manager at Pfizer. In addition, children “play an important role in the transmission” of the virus among the general population, he added.

Prior to the meeting, the FDA had released its own interpretation of the data, clearly pointing in favor of authorization.

No cases of myocarditis detected during clinical trials

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. At least 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 of “clinically significant problems” related to Covid-19 avoided thanks to the vaccine “would clearly counterbalance the surplus of myocarditis cases”.

Committee member Dr Paul Offit said he was reassured that the dosage for children was lower (10 micrograms per injection instead of 30 for older groups).

Parents’ skepticism

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.

Children can be vaccinated by pediatricians, pharmacies or even certain schools.

As with adults and adolescents, the vaccine requires two injections, three weeks apart.

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. vaccinate.

With AFP and Reuters