Pfizer and BioNTech requested the Food and Drug Administration (FDA) to approve the emergency use of their COVID-19 vaccines for children ages 5 to 11 years old.
The Pfizer-BioNTech vaccine is now fully approved for people who are 16 years old and older. This vaccine is also approved for emergency use for 12 to 15 years old people. The pharmaceutical company claimed that they haven’t found any serious side effects during the vaccine trial for 5- to 11-year-olds kids.
The FDA’s vaccine advisory committee will now analyze the data submitted by the companies supporting the use of the vaccines in this young age group. Recently Pfizer wrote on Twitter, “With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19.”
The company revealed a phase 2 and 3 trial report that showed the vaccine has generated a “robust” immune response in children 5 to 11 years old. Approximately 2,268 children from the United States participated in these trials. The children received two doses of the vaccine and the researchers measured children’s immune response by evaluating the level of neutralizing antibodies in their blood.
The company statement stated, “These results — the first from a pivotal trial of any COVID-19 vaccine in this age group — were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 microgram doses.”