US experts vote on Pfizer’s vaccine for young children

published on Tuesday, October 26, 2021 at 4:05 p.m.

American experts were examining Pfizer’s request for authorization of the Covid-19 vaccine for 5 to 11 year-olds on Tuesday, during a meeting which should, barring any surprise, pave the way for the very imminent vaccination of some 28 million children in the United States.

An advisory committee of the American Medicines Agency (FDA), made up of independent scientists (immunologists, experts in infectious diseases, pediatrics, etc.), was assembled to review the data provided by Pfizer.

At the end of the debates, broadcast live on the internet, they will have to vote on the following question: do the benefits of the vaccine for children aged 5 to 11 outweigh the risks?

The advice of these experts is a crucial step in the authorization process in the United States, as it is rare that the FDA does not follow it. The agency will then still have to officially validate the vaccine for this age group, potentially in the following hours or days.

The opening of vaccination to young children should reassure many parents.

Children “are far from being spared from the damage of Covid-19,” said Peter Marks, of the FDA, in the introduction of the meeting.

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 detailed .

– Few expected myocarditis –

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.

The dosage was adjusted to 10 micrograms per injection (two in number, given three weeks apart), compared to 30 micrograms for the older groups.

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

The regulator was initially worried that the vaccine could cause in children a significant number of cases of myocarditis, an inflammation of the heart muscle, because this side effect has been detected in particular in adolescents and young adults (especially males).

Among the 3,000 children vaccinated in total during clinical trials, no cases of myocarditis were detected. Experts believe this side effect should be rarer in young children than in adolescents, the smaller dosage helping.

This does not mean that rare cases will not occur despite everything. 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”.

Children with Covid-19 can in particular develop a pediatric multisystem inflammatory syndrome (MIS-C), or even a “long Covid”. The disease itself can also cause myocarditis.

“For me, it’s not even a question, children need to be vaccinated,” Henry Bernstein, a pediatrician at Cohen Children’s Hospital near New York, told AFP.

The vaccination of children is also not only beneficial for them, he argued, but also for the adults around, because it helps to slow down the transmission of the virus.

– Injections from November –

If 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, and this federal agency will then publish its recommendations on the methods of administering doses to healthcare professionals.

The injections could then begin at the beginning of November.

The White House has indicated that it is ready to send to the four corners of the country, immediately after the FDA’s decision, approximately 15 million doses.

The government will also provide needles smaller than those used for adults.

Children can be vaccinated by pediatricians, in tens of thousands of pharmacies, or even in certain schools.

It will still be necessary to convince.

According to a Kaiser Family Foundation poll 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.

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