FDA Authorizes COVID-19 Vaccine for Children

As of Oct. 29, the Food and Drug Administration has authorized the use of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age. The FDA states that this authorization was based on thorough evaluation of data that “input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.”

They also listed “Key Points” for parents and caregivers of children:

• “Effectiveness: Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In addition, the vaccine was found to be 90.7% effective in preventing COVID-19 in children 5 through 11.
• Safety: The vaccine’s safety was studied in approximately 3,100 children aged 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
• The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.”

This vaccine is administered as a two-dose series, the second shot being three weeks apart from the first. It is also a lower dosage (10 micrograms) than that of which is administer to those 12 years of age and up (30 micrograms). The FDA also noted that in the U.S., “COVID-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age.”

According to the CDC, “approximately 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization. As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals less than 18 years of age, with 146 deaths in the 5 through 11 years age group.”

The FDA has also determined that the Pfizer vaccine has met the criteria for emergency use. The potential benefits of the Pfizer-BioNTech COVID-19 vaccine outweighs the known and potential risks for all individuals down to five years of age.

Peter Marks, M.D., Ph. D, director of the FDA’s Center of Biologics Evaluation and Research made this statement:

“The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust.  We are confident in the safety, effectiveness, and manufacturing data behind this authorization. As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon. We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated.”