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Kid-size doses of Pfizer COVID-19 vaccine in Puurs, Belgium in October 2021. (Pfizer via AP) The Food and Drug Administration (FDA) said in a report on Friday that Pfizer-BioNTech’s COVID-19 vaccine meets the agency’s criteria for the immune response it generated in children aged 5 to 11; the agency also said that the vaccine would likely provide more benefits than risks in most scenarios.
The FDA briefing document ( pdf ) was published ahead of a scheduled meeting of a panel of outside experts on Oct. 26. Members of the Vaccines and Related Biological Products Advisory Committee are to vote on that day on whether they would recommend the FDA to authorize the shots.
In the document, the FDA acknowledged results from Pfizer released earlier in the day that said the two-dose vaccine was nearly 90.7 percent effective against the CCP (Chinese Communist Party) virus in a clinical trial of the children aged 5–11.
Pfizer’s clinical trial was not primarily designed to measure efficacy against the virus. The trial compared the amount of neutralizing antibodies induced by the vaccine in the children to the response of older recipients in their adult trial. Based on those results, Pfizer-BioNTech said last month that their COVID-19 vaccine induced a robust immune response in the children.
The FDA noted no new or unexpected side effects. Adverse effects in the Pfizer trial included sore arms, fever, or achiness. The FDA said 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. Benefits Outweigh Risks: FDA
The FDA used statistical modeling to analyze whether the benefits would outweigh risks from the Pfizer vaccine for the young age group. It found that, over a 6-month period, the vaccine for children aged 5–11 provided more benefits than risks in six scenarios of varying COVID-19 incidence.
The modeling evaluated predicted numbers per million of preventable symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions, and deaths. It compared those figures with predicted numbers per million of vaccine-associated excess myocarditis/pericarditis cases, hospitalizations, ICU admissions, and deaths attributable to […]
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