In a significant development that many parents have been anticipating, Pfizer and BioNTech announced on Thursday that they have submitted a request to the FDA for emergency authorization of their COVID-19 vaccine for children aged 5 to 11. If approved, this would allow an additional 28 million children in the United States to receive the vaccine. The pharmaceutical companies have provided data to the FDA demonstrating that the vaccine is both safe and effective for this younger demographic.
The FDA has indicated that it will expedite its review of this request, particularly in light of the ongoing surge in pediatric COVID-19 cases driven by the delta variant. A meeting to discuss the submitted data is tentatively scheduled for October 26, and a decision is expected to be made between Halloween and Thanksgiving.
Parents have been eagerly awaiting vaccine availability for children, especially with schools reopening for in-person classes amid rising delta variant cases. Vaccinating children would enhance their protection during family activities and help minimize interruptions to their education. This school year has already seen several disruptions due to COVID outbreaks, forcing some schools to close temporarily and sending many students into isolation after exposure.
The announcement comes at a time when pediatric COVID-19 cases are at an all-time high, with 30,000 children hospitalized in August alone. According to the American Academy of Pediatrics, 5.9 million children have been infected since the pandemic began, with approximately 500 fatalities among individuals under 18, including 125 in the 5 to 11 age group—the specific cohort eligible for the Pfizer vaccine if authorized.
The vaccine tested on children is approximately one-third of the adult dosage. The FDA will assess the safety and efficacy data, as well as the vaccine’s purity and stability during mass production. Additionally, considerations will need to be made regarding packaging and labeling for the children’s dosage, and whether a two-dose regimen is necessary or if a single dose provides adequate protection.
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Summary:
Pfizer and BioNTech have requested FDA emergency authorization for their COVID-19 vaccine for children aged 5 to 11, potentially expanding eligibility to 28 million more kids in the U.S. The FDA is set to review the request quickly due to rising pediatric cases linked to the delta variant, with a decision expected between Halloween and Thanksgiving. The vaccine is one-third the adult dose, and safety, efficacy, and dosing will be evaluated.