On the eve of Halloween this Friday, the U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine in children 5 to 11 years of age after recent studies showed that it has a positive effect on the vaccine. (FDA) cleared the Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 to 11 years of age after recent studies showed it to be more than 90 percent effective and safe for that age group.
The clearance, the FDA said in a comunicadowas based on a thorough and transparent evaluation of the data that included input from experts on the independent advisory committee who voted overwhelmingly in favor of making the vaccine available to children in this age group.
The immune responses of children 5 to 11 years of age were comparable to those of people 16 to 25 years of age, and it was found to be 90.7 percent effective in preventing COVID-19 in that age group.
The safety of the vaccine was studied in approximately 3,100 children aged 5 to 11 years and no serious side effects have been detected.
The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.
"As a parent and physician, I know that parents, caregivers, school staff and children have been waiting for today's clearance. Vaccinating the youngest children against COVID-19 will get us closer to getting back to normal," said FDA Acting Commissioner Janet Woodcock.
"Our thorough and rigorous evaluation of the data related to the safety and efficacy of the vaccine should help assure parents and guardians that this vaccine meets our high standards," he added.
The Pfizer-BioNTech COVID-19 vaccine for children 5 to 11 years of age is given as a two-dose primary series, 3 weeks apart, but is a lower dose - 10 micrograms - than the one used for people 12 years of age and older - 30 micrograms.
In the United States, cases of COVID-19 in children aged 5 to 11 account for 39 percent of cases in people under the age of 18. According to the CDC, approximately 8,300 cases of COVID-19 in children aged 5 to 11 resulted in hospitalization, and as of Oct. 17, 691 COVID-19 deaths had been reported nationwide in people under the age of 18, of which 146 deaths were in the 5- to 11-year-old age group.
"As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we are releasing documents today that support our decision and additional information detailing our evaluation of the data will be released soon. We hope this information will help build confidence in parents who are deciding whether to vaccinate their children," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
The FDA has determined that this Pfizer vaccine meets the criteria for emergency use authorization. Based on the totality of the available scientific evidence, the known and potential benefits of Pfizer-BioNTech COVID-19 vaccine in people younger than 5 years of age outweigh the known and potential risks.
Frequently reported side effects in the clinical trial included pain at the injection site, arm pain, redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea, and decreased appetite.
More children reported side effects after the second dose than after the first dose. Side effects were generally mild to moderate in severity and occurred within two days after vaccination, with most disappearing within one to two days.
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