Pfizer Seeks FDA Authorization , To Use COVID Vaccine <br />for Children Ages 5 to 11.<br />Pfizer and BioNTech announced they were seeking approval from the U.S. Food and Drug Administration (FDA) on Oct. 7.<br />In the U.S., the Pfizer COVID-19 vaccine has been approved for those who are 16 and older.<br />In the EU, children ages 12 through 15 <br />are able to receive the vaccine.<br />Pfizer released data last month from a <br />Phase 2/3 trial which showed that its COVID-19 vaccine was safe... .<br />... and provided a "robust" antibody response to the virus in children between the ages of five and 11.<br />The dosage used for children between these ages was a third of the dosage used in people 15 and older.<br />Now that Pfizer has officially requested approval for use of the vaccine in children... .<br />... FDA officials have indicated that <br />with supporting data, it could be approved <br />in a matter of weeks.<br />The FDA Vaccines and Related Biological Products Advisory Committee is set to meet to discuss authorization on Oct. 26.<br />The acting director of the FDA recently outlined the considerations for the upcoming committee meeting.<br />We know from our vast experience with other pediatric vaccines that children are not small adults, .., Dr. Janet Woodcock, Acting FDA Commissioner, via CNN.<br />... and we will conduct a comprehensive evaluation of clinical trial data submitted <br />in support of the safety <br />and effectiveness of the <br />vaccine used in a younger <br />pediatric population, .., Dr. Janet Woodcock, Acting FDA Commissioner, via CNN.<br />... which may need a different dosage or formulation from that used in an older pediatric population or adults, Dr. Janet Woodcock, Acting FDA Commissioner, via CNN.<br />If approved by the FDA, a Centers for Disease Control and Prevention (CDC) committee will then consider approval as well
