FDA Authorizes Pfizer COVID Vaccine for Children

The Food and Drug Administration (FDA) authorized the use of Pfizer’s COVID vaccine for emergency use in children ages 5–11 years of age. The FDA approved this authorization after extensive evaluation of the data that has been collected from their independent advisory committee of experts and the support in favor of making the vaccine available to children, with a vote of 17 in favor and one abstention.

The data collected shows that the immune responses in children aged 5–11 were comparable to the immune responses of those aged 16–25, and the vaccine was found to be 90.7% effective in preventing COVID-19 in children of the newly approved age group. No serious side effects have been reported by the 3,100 children involved in this ongoing study.

The Center for Disease Control and Prevention (CDC) will be meeting in the upcoming week to discuss continued clinical recommendations. As with those 12 and over, the Pfizer vaccine will be administered as a two-dose series, three weeks apart; however, the dosage has been reduced from 30 micrograms to 10 micrograms for anyone in the 5–11 age group.

The Biden administration has stated plans to distribute the doses as soon as it has been authorized by both the FDA and the CDC, expected next month. They have also stated that they have procured enough vaccines to inoculate 28 million children within the new age bracket in the United States.

Over the past 6 weeks, more than 1.1 million new COVID cases in children have been reported; children ages 5–11 account for around 9% of all reported cases. Some committee members believe that lowering the age of vaccination can help move COVID into an endemic phase in the U.S.

Acting FDA Commissioner Janet Woodcock, M.D. stated: “As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy. Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

The FDA will also post documents regarding their decision making and data evaluation to show their commitment to transparency in decision making and their confidence in the safety, effectiveness, and manufacturing data behind the authorization.