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The Food and Drug Administration released its analysis of Pfizer data ahead of a public meeting next week to discuss whether vaccines are ready for the nation’s approximately 28 million children aged 5 to 11. The agency will ask a panel of outside vaccine experts to vote on this issue.
In their analysis, the FDA scientists concluded that in almost all scenarios, the benefits of the vaccine for preventing hospitalizations and deaths from Covid-19 would outweigh the potential serious side effects in children. But the agency’s critics did not ask for permission to shoot Pfizer.
The agency will pose this question to its panel of independent advisers next Tuesday and assess their advice before making its own decision.
If the FDA allows the injections, the Centers for Disease Control and Prevention will make additional recommendations on who should receive them the first week of November. Children could start immunizations early next month – with the first young people in the line fully protected by Christmas.
Pfizer full strength injections are already recommended for anyone 12 years of age or older, but pediatricians and many parents eagerly await the protection of young children to stem infections of the extra-contagious delta variant and help keep children alive. at school.
Most of the study data was collected in the United States in August and September, when the delta variant became the dominant COVID-19 strain.
The FDA review did not reveal any new or unexpected side effects, which were mainly arm pain, fever, or body aches in adolescents.
However, FDA scientists noted that the study was not large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that sometimes occurs after the second dose.
It was only when the virus cases were extremely low that the vaccine would cause more hospitalizations than it prevented. But overall, regulators concluded that the vaccine’s protective benefits “would clearly outweigh” its risks.
While children are at a lower risk of serious illness or death than the elderly, Covid-19 has killed more than 630 Americans aged 18 and under, according to the CDC. Nearly 6.2 million children have been infected with the coronavirus, more than 1.1 million in the past six weeks as the delta variant has increased, according to the American Academy of Pediatrics.
The Biden administration has purchased enough children’s doses – in special orange-capped vials to distinguish them from the adult vaccine – for children aged 5 to 11 nationwide. If the vaccine is cleared, millions of doses will be quickly shipped across the country, along with needles for children.
More than 25,000 pediatricians and primary care providers have already signed up to receive the small arms injections.