FDA Emergency Use Authorization Granted to Pfizer COVID-19 Vaccine in Children Between 5 and 11


Emergency Use Authorization granted for young children may address cases of severe disease, which is more common in pediatric patients with cancer compared with children without cancer.

The FDA has authorized the use of Pfizer-BioNTech COVID-19 vaccine in children between 5 and 11 years of age, including in those with pediatric cancers, according to a press release by the FDA.1

The vaccine was found to be 90.7% effective in preventing COVID-19 in this age group, which is comparable to the efficacy seen in those 16 through 25 years of age. Additionally, in the 3100 children analyzed for safety, no serious adverse events (AEs) have been reported in the ongoing study, supporting the emergency use authorization (EUA). 

“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research in a press release.

Up to 39% of all COVID-19 cases in individuals under 18 years of age are children between the ages of 5 through 11, and approximately 8300 children in this age group have been hospitalized for the disease and 146 have died. Children with cancer are even more vulnerable to the disease, with a mortality rate of 4% compared to just 0.01 to 0.7% in the general pediatric population.

A study published in The Lancet Oncology found that pediatric cancer patients between the ages of 1 and 9 made up of 54.9% of all COVID-19 cases in the pediatric cancer population. The most common cancer type represented was acute lymphoblastic leukemia or acute lymphoblastic lymphoma.2

Mild or moderate symptoms were seen in 45% of all pediatric cancer patients diagnosed with COVID-19. Severe or critical disease was seen in 19.9% of patients. COVID-19 infection led to treatment modification in 55.8% of kids infected and of those who died, COVID-19 was the cause in 60.2% of incidents. The median time to death from diagnosis was 8 days. Of all pediatric cancer patients who were diagnosed with COVID-19, only 32.6% weren’t hospitalized. 

“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,” said acting FDA commissioner Janet Woodcock, MD, in a press release. “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 study supporting the EUA enrolled more than 4600 patients, 3100 of which received the vaccine while 1538 received the placebo. A total of 1444 patients were followed for at least 2 months after their second dose. Common AEs included injection site pain, redness, swelling, fatigue, headache, muscle or joint pain, fever, swollen lymph nodes, and decreased appetite. Most AEs resolved within 2 days after onset, which typically occurred within 2 days of vaccination.

Like the vaccine authorized for individuals 12 years of age and older, the vaccine is administered as a 2-dse series, 3 weeks apart. However, dosing for the 5-11 cohort is a third of what it is for the 12 and over cohort (10 micgroams versus 30 micrograms).

1.FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age. News release. October 29, 2021. Accessed November 1, 2021. https://bit.ly/3buG3MT.
2.Mukkada S, Bhakta N, Chantada G, et al. Global characteristics and outcomes of SARS-CoV-2 infection in children and adolescents with cancer (GRCCC): a cohort study. Lancet Oncol. 2021;22:1416-26 doi: 10.1016/ S1470-2045(21)00454-X

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