Federal health regulators said late Friday that kid-size doses of Pfizer’s COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children and caused no unexpected safety issues, as the U.S. weighs beginning vaccinations in youngsters.
The Food and Drug Administration posted its analysis of Pfizer’s data ahead of a public meeting next week to debate whether the shots are ready for the nation’s roughly 28 million children ages 5 to 11. A panel of vaccine experts from outside will vote for the agency on this question.
In their analysis, FDA scientists concluded that in almost every scenario the vaccine’s benefit for preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children. But agency reviewers stopped short of calling for Pfizer’s shot to be authorized.
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This question will be put to the panel of independent advisers by the agency next Tuesday. The agency will then evaluate their recommendations before it makes its decision.
The FDA will authorize the shots. If not, the Centers for Disease Control and Prevention (CDC) will issue additional recommendations about who should get them in the first week. Children could begin vaccinations early next month — with the first youngsters in line fully protected by Christmas.
Pfizer full-strength shots are already recommended for those 12 and older. However, many parents and pediatricians are eagerly waiting for protection for their children as they face the additional-contagious delta variant.
FDA reviewed Pfizer’s earlier-in-the day results that showed the two dose shot prevented symptomatic infections in children under the age of nine years. This figure was calculated using data from 16 children with COVID-19 who had received dummy shots and three in children who were not vaccinated. The children were healthy, with no serious illnesses. However, the unvaccinated had milder symptoms.
The majority of study data was collected during the August/September period in the U.S., when the Delta variant became the predominant COVID-19 strain.
FDA reviewed the FDA and found no unexpected or new side effects. The side effects that did exist were mostly sore arms and fever.
However, FDA scientists noted that the study wasn’t large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that occasionally occurs after the second dose.
It used statistical modeling and mathematical modelling to determine how many deaths or hospitalizations COVID-19 vaccine could prevent, as well as the potential side effects to the heart. Four scenarios showing the pandemic were shown to show that the vaccine did not prevent more hospitalizations than it would have been expected due to the side effects. The vaccine could only cause greater hospitalizations if the virus incidences were very low. But overall, regulators concluded that the vaccine’s protective benefits “would clearly outweigh” its risks.
According to the CDC, children are at lower risk for severe illness and death than those who are older than them. However, COVID-19 is responsible for more than 630 deaths in America aged 18 or under. The American Academy of Pediatrics reports that nearly 6.2 million children were infected by the coronavirus. This is more than the 1.1 million who contracted it in six weeks, as the number of cases of the delta virus exploded.
The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s 5- to 11-year-olds. Millions of vaccine doses, as well as kid-sized needles, will be shipped out to the nation if the vaccine has been cleared.
Over 25,000 primary care and pediatricians have already signed up for the vaccines.
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Lindsey Tanner (AP Medical Writer) contributed to the story.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. All content is the sole responsibility of the Associated Press.
