FDA authorizes Pfizer COVID vaccine for younger kids

Regulatory NewsRegulatory News | 29 October 2021 |  By 

The first US emergency use authorization (EUA) for younger children to receive a COVID-19 vaccine has been issued, the US Food and Drug Administration (FDA) announced Friday afternoon.
The mRNA vaccine developed by Pfizer in conjunction with the German firm BioNTech is now authorized for use in children aged 5-11 years. The Centers for Disease Control and Prevention (CDC) will convene a meeting of its immunization advisory committee next week to review clinical parameters for use of the vaccine, with an expected okay from the CDC coming as early as the middle of the first week of November.
FDA’s actions come just 3 days after the Vaccines and Related Biological Products advisory committee (VRBPAC) meeting that saw near-unanimous agreement that the benefits of a two-dose, 10 mcg regimen of the Pfizer vaccine outweighed risks for the 5–11-year age group. VRBPAC saw data at that meeting showing that the vaccine was 90.7% effective at preventing COVID-19 among these younger children, a figure similar to that seen among older adolescents and young adults. (RELATED: Near-unanimous adcomm nod on Pfizer COVID vaccine for younger kids, Regulatory Focus 26 October 2021)
Looking at the data another way, the immune responses of younger children who received this half-strength dose were comparable to those seen in trial participants 16-25 years old who receive the full 30 mcg dosing.
Safety data submitted by Pfizer in support of the EUA showed no serious adverse events in the study cohort of over 3,000 children aged 5-11 years; followup of these children is ongoing.
“We are confident in the safety, effectiveness and manufacturing data behind this authorization,” said Peter Marks, chief of FDA’s Center for Biologics Evaluation and Research, in the press release announcing the EUA. “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."
In a Friday afternoon press conference, acting FDA commissioner Janet Woodcock and Marks each reviewed portions of the efficacy and safety data used as the basis of the decision, and then answered questions from the press.
In response to a question regarding VRBPAC’s “lively” consideration of the benefit-risk balance for younger children, Marks responded, “Whenever we’re thinking about children we try to be as careful as we can.” Although some discussion was had about authorizing the vaccine for certain at-risk younger children rather than for the entire age group, most VRBPAC members, said Marks, were ultimately persuaded by data showing that about 1 of every 3 children hospitalized for COVID-19 did not have known comorbidities.
Further, noted Woodcock, equity concerns are also better addressed by a vaccine strategy that aims to get shots into the arms of as many members of the general population as possible.
Woodcock declined to set a timeline for when full approval of Pfizer’s COVID-19 vaccine might come for this younger age group. And Marks made clear that it will be “several months” before any authorization will be considered for still younger children and infants, in part because of later clinical trial initiation and in part because the lower incidence rate of COVID-19 and serious disease in this group shifts the risk-benefit equation.
“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 Woodcock in the 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.”


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