In the United States, a committee of experts ruled on Tuesday, October 26, in favor of immunization to Covid-19 of 5-11 years with the vaccine of Pfizer-BioNTech, but has a lower dose. If the U.S. Drug Agency authorizes it, injections could begin as early as early November for some 28 million American children”s. The decision could influence practice in other countries.
An advisory committee of the US Drug Agency (FDA), composed of independent scientists (immunologists, experts in infectious diseases, pediatrics…), decided that the benefits of the Pfizer-BioNTech vaccine for children aged 5 to 11 outweigh the risks.
The opinion of these experts is a crucial step in the authorization process in the United States, because 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, a priori in the following days. If so, injections could begin as early as early November.
1.9 million cases, more than 8,300 hospitalizations
Children “are far from being spared the damage of Covid-19,” recalled Peter Marks, of the FDA, in introduction.
Among 5 to 11 years old, 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.
Children who catch the virus may develop pediatric multi-systemic inflammatory syndrome (MIS-C), or “long Covid”.
Point of debate: myocarditis
To support its application for authorization, Pfizer presented the results of a clinical trial that demonstrated a 90.7% efficacy of the vaccine to prevent symptomatic forms of the disease in 5 to 11 years of age.
In addition, “Vaccination will help ensure in-person learning” at school, “crucial for children’s development,” argued William Gruber, head of Pfizer. In addition, children “play an important role in the transmission” of the virus among the general population, he added.
The main point of debate concerns the risk of vaccine-induced myocarditis. This inflammation of the heart muscle is a side effect that has especially been detected in adolescents and young adults (especially male) after Pfizer or Moderna.
Health authorities have confirmed nearly 880 cases (more than 600 remain to be evaluated), of which about 830 required hospitalization. At least about 790 have since returned home, and no deaths have been recorded.
Of the 3,000 children vaccinated in total during Pfizer clinical trials, no cases of myocarditis were detected. Even if this does not mean that the risk is absent, experts believe that this side effect should be rarer in young children, as it could be related to testosterone levels.
The FDA analysis therefore predicts that the number of “clinically significant problems” related to Covid-19 prevented with the vaccine would “clearly counterbalance the surplus of cases of myocarditis”.
In detail, hospitalizations for Covid-19 avoided would outnumber hospitalizations for vaccine-related myocarditis under most scenarios.
Start of injections as early as November
If the FDA gives the green light, a committee of experts from the 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 on how to administer the doses. Injections could then begin as early as early November.
The White House has indicated that it is ready to send millions of doses across the country.
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.