"Children 5 to 11 Can Now Be Vaccinated" FDA Approved

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Published by TDP on October 31, 2021

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Illustration of four smiling children with virus icons above them, and the text “COVID-19 Vaccine — FDA approved for children vaccination ages 5 to 11” in bold red letters.

On October 29, 2021 Earlier this month, the United States Food and Drug Administration approved the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in children ages 5 to 11 years. In order to get authorization, the FDA conducted a comprehensive and public examination of the data, which included participation from independent advisory committee specialists who overwhelmingly decided to make the vaccine accessible to children in this age range.

When delivered as a two-dose main series, three weeks apart, the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age has a lower dosage (10 micrograms) than when provided to persons 12 years of age and older (30 micrograms).

COVID-19 cases in children aged 5 to 11 years in the United States account for 39 percent of all cases in persons less than 18 years of age in the country. According to the Centers for Disease Control and Prevention, roughly 8,300 COVID-19 cases in children aged 5 to 11 years resulted in hospitalization. As of Oct. 17, 691 COVID-19-related fatalities among persons under the age of 18 have been documented in the United States, with 146 of those deaths occurring in children between the ages of 5 and 11.

Safe?

When it comes to youngsters 5 to 11 years old, Pfizer has amended its safety monitoring strategy to include review of myocarditis, pericarditis, and other events of interest in addition to the standard evaluation. Additional procedures are in place by the FDA and the CDC to continuously monitor COVID-19 vaccine safety and to enable for the prompt discovery and investigation of any possible safety issues that may arise from the vaccination.

It is required for Pfizer Inc. and immunization providers to report to the appropriate authorities any major adverse events, instances of Multisystem Inflammatory Syndrome, and cases of COVID-19 that result in hospitalization or death in persons who have received the vaccine. Also required is for vaccination providers to report any and all vaccine administration errors to VAERS that they become aware of, as well as for Pfizer Inc. to include a summary and analysis of all identified vaccine administration errors in its monthly safety reports to the Food and Drug Administration.

In the novel vaccine formulation produced by Pfizer Inc., Tris buffer is included, which is a regularly used buffer in a wide range of other FDA-approved vaccines and other biologics, including those intended for use in children. The Food and Drug Administration reviewed manufacturing data to support the use of Pfizer-BioNTech COVID-19 Vaccine using Tris buffer and decided that it does not pose a threat to public health or safety.

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