U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children

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By Reuters
U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children
U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children   -   Copyright  Thomson Reuters 2021   -  

<div> <p> – An expert panel will weigh authorization of Pfizer Inc and BioNTech’s <span class="caps">COVID</span>-19 vaccine for children aged 5 to 11 on Tuesday as it prepares to vote on a recommendation for the U.S. Food and Drug Administration.</p> <p>The panel’s vote is an important regulatory step in getting the vaccine into the arms of millions of children in the United States where schools are largely open for in-person learning.</p> <p>The <span class="caps">FDA</span> need not follow the advice of its outside experts, but usually does.</p> <p>Only a few other countries including China, Cuba and the United Arab Emirates have cleared <span class="caps">COVID</span>-19 vaccines for children in this age group and younger.</p> <p>The advisers are expected to pay close attention to the rate of rare cases of heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men. </p> <p>Pfizer and BioNTech are seeking clearance for a lower, 10 microgram dose version of the vaccine in children, versus 30 micrograms for everyone over the age of 12. The shot has been authorized for ages 12-15 since May and cleared for everyone over 16 since December.</p> <p>The companies have said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.</p> <p>After the <span class="caps">FDA</span>, a panel to the U.S. Centers for Disease Control and Prevention will make a recommendation on the administration of the vaccine. The director of the agency will make the final call.</p> <p>“If all goes well, and we get the regulatory approval and the recommendation from the <span class="caps">CDC</span>, it’s entirely possible if not very likely that vaccines will be available for children from 5 to 11 within the first week or two of November,” top U.S. infectious disease expert Anthony Fauci said on Sunday.</p> <p><span class="caps">FDA</span> staff, in documents posted before the meeting, said the likely vaccine benefits in that age group clearly outweigh the potential harms, including the rare risk of heart inflammation.</p> <p>If the number of myocarditis cases in the younger age group turns out to be similar to that in 12- to 15-year-olds, the hospitalizations prevented for <span class="caps">COVID</span>-19 would outnumber those prevented for myocarditis in most scenarios analyzed, <span class="caps">FDA</span> staff reviewers said.</p> <p>While children rarely become seriously ill or die from <span class="caps">COVID</span>-19, some develop complications, and <span class="caps">COVID</span>-19 cases in unvaccinated children have risen due to the contagious Delta variant.</p> <p>Pediatric vaccinations are an important public health tool to prevent infectious diseases, even ones that do not cause high rates of mortality or hospitalization for children. </p> <p/> </div>