CDC Signs Off on Pfizer’s COVID-19 Vaccine for Children Aged 5-11 Years

Children aged 5 to 11 years can now receive the Pfizer-BioNTech mRNA COVID-19 vaccine, according to a November 2, 2021 press release from the US Centers for Disease Control and Prevention (CDC).

CDC Director Rochelle Walensky, MD, MPH, officially endorsed the vaccine in children after the agency’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to recommend vaccinating this pediatric population with a 2-dose regimen (10 μg each) given 3 weeks apart.

“We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine,” stated Walensky in the CDC press release. “As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated.”

The decision came days after the Food and Drug Administration (FDA) authorized Pfizer’s COVID-19 vaccine for emergency use in children aged 5 to 11 years, based on available efficacy and safety data.

Clinical trials in children aged 5 to 11 years showed the vaccine was 90.7% effective in preventing COVID-19, and the immune responses in this age group were similar to those seen in persons aged 16 to 25 years. Safety data from the trials, which included approximately 3100 children who received Pfizer’s vaccine, found the most common side effects included injection site pain, headache, and fatigue. Side effects were mostly mild or moderate and generally subsided within 1 to 2 days.

Distribution of Pfizer’s COVID-19 vaccine began this week and will be scaled up to full capacity starting the week of November 8, 2021, according to the CDC. A fact sheet from the White House notes that the Biden administration, partnering with states and localities, will make the pediatric vaccines available through more than 25 000 pediatric offices and other primary care sites as well as through children’s hospitals and health systems across the US.