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Washington (AFP)
Pfizer announced Thursday that it has requested emergency authorization in the United States to administer its coronavirus vaccine to children between the ages of 5 and 11, a new step in the coronavirus immunization campaign eagerly awaited by many parents.
The first injections could begin within a few weeks, after a study of the data by the US health authorities.
“As new cases in children in the United States continue at a high level, this request is an important step in our continued efforts against covid-19,” tweeted the American pharmaceutical Pfizer, which developed its vaccine with the German laboratory BioNTech.
The US drug regulatory agency, the FDA, noted that after the formal submission of the application, it may take “a few weeks” before the doses can actually be administered to young children.
The FDA already has a meeting scheduled for Oct. 26 with its advisory committee, which will have to provide input before authorization is officially granted.
The Centers for Disease Control and Prevention (CDC), the nation’s main federal public health agency, should then publish precise recommendations for use for healthcare professionals who administer the doses.
“We are ready, we have the supplies,” Jeff Zients, the White House pandemic response coordinator, told CNN Thursday morning.
There are an estimated 28 million children between the ages of 5 and 11 in the United States, according to 2019 data from the Census Bureau.
– Proper dose –
The Pfizer / BioNTech alliance had already submitted the results of its vaccine trials for this age group to the FDA in late September.
Pfizer / BioNTech conducted these trials in more than 2,000 children between the ages of 5 and 11. They reported that the vaccine was well tolerated and elicited a “robust” immune response, “comparable” to that seen in people aged 16 to 25 years.
The dose has been adjusted to 10 micrograms per injection, compared to 30 micrograms for the older age groups.
Many parents have been anxiously awaiting the approval of vaccines for their young children, especially since the beginning of the school year and the return of face-to-face classes.
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According to a survey by the Kaiser Family Foundation in late September, among parents with a child between the ages of 5 and 11, about a third say they will get it vaccinated as soon as possible. Another third say they will wait before making a decision, and a quarter say they will not vaccinate.
Younger people are less likely to develop severe cases, but they can still become ill and transmit the virus within the population.
Health authorities will focus in particular, during their study of the data, on the risks of myocarditis, an inflammation of the heart muscle that has been shown to be seen more frequently in young adults and adolescents after vaccination against COVID with immunizers from Pfizer and Modern, they use messenger RNA technology.
The number of children participating in clinical trials has therefore been expanded, at the request of health authorities, to allow better detection of these rare possible side effects.
The question will be to determine the benefits and risks of administering the vaccine in these children.
– And before the age of 5? –
According to a count by the American Academy of Pediatrics, as of September 30, about 5.9 million children have been infected with COVID-19 since the start of the pandemic early last year.
And a few hundred have died, according to CDC figures.
At the moment in the United States, Pfizer’s vaccine has full FDA clearance for people 16 years of age and older, and emergency clearance for those 12 to 15 years of age.
The Pfizer / BioNTech alliance said it expects to be able to publish “from the fourth quarter” test results for two other age groups, 2 to 5 years and 6 months to 2 years.
Moderna is also conducting clinical trials of its coronavirus vaccine in thousands of children, the results of which have yet to be published.
In Israel, children from 5 to 11 years old at risk of serious complications from covid-19 can already be vaccinated from August 1 with Pfizer, under a “special authorization”.
© 2021 AFP
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