USA: study effectiveness of Pfizer vaccine for children

US government advisers began discussions Tuesday about whether there is evidence that Pfizer’s pediatric COVID-19 vaccine is safe and effective for children ages five to 11.

A study of elementary school children found that Pfizer vaccines prevent symptomatic infection in 91% of cases, although it is one-third of the dose that adolescents and adults receive.

In a preliminary analysis last week, Food and Drug Administration officials said the protection would “far outweigh” the risk of a highly unusual side effect in almost all pandemic scenarios. Now FDA advisers are carefully studying that data to see if they agree.

If the FDA authorizes pediatric doses, one step is missing: Next week the Centers for Disease Control and Prevention must decide whether to recommend them and which children should receive them.

While the risk of severe COVID-19 is lower in children than in adults, there have been cases among the five to 11-year-olds, with more than 8,300 hospitalizations, a third of which required intensive care. and nearly 100 deaths, FDA vaccine chief Dr. Peter Marks told the advisory panel.

“The infections have caused the closure of many schools and disrupted the education and socialization of children,” he added.

“I want to acknowledge the fact that there are strong feelings” in the public for and against vaccination, Marks said. He added that the discussion would be on scientific data, “not on vaccination orders, which correspond to other agencies outside the FDA.”

Adult dosages from Pfizer and its partner BioNTech are recommended for everyone 12 years and older, but pediatricians and many parents cry out for protection for children. The highly aggressive delta variant has led to an alarming increase in pediatric infections. For their part, families are furious at school quarantines and having to say no to parties and other childhood rituals to keep the virus away.

States are preparing to distribute the vaccines – in vials with an orange cap to distinguish them from adult doses – as soon as the government gives the green light. More than 25,000 pediatricians and other primary care providers have declared themselves vaccine providers.

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