The Food and Drug Administration has issued an emergency authorization for the use of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11.
The FDA’s authorization follows the recommendation of its independent advisory committee, which earlier this week voted nearly unanimously in favor of authorizing the vaccine. The committee of 18 voting members voted 17 to 0 in favor, with one abstention.
In a day-long meeting Tuesday, advisors pored over data and analyses of the vaccine in the younger children, who will receive two shots of a 10-microgram dose—a third of the dosage used in people ages 12 years and up—three weeks apart. Data from clinical trials suggest that the smaller dose in children produces equally strong immune responses as those seen in older age groups while minimizing the risks of side effects.
A clinical trial run by Pfizer and BioNTech involving about 2,250 children ages 5 through 11 suggested that the vaccine was about 91 percent effective at preventing symptomatic disease. Data from around 3,100 children found no serious side effects.
“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,” Acting FDA Commissioner Janet Woodcock said in a statement. “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.”
Before children can get the vaccine, the Centers for Disease Control and Prevention and its panel of independent advisors will also need to weigh in. As Ars noted earlier, that panel—the Advisory Committee on Immunization Practices (ACIP)—is scheduled to meet on November 2 and 3. According to a recently posted agenda, the committee will discuss the vaccine on Tuesday, November 2, and vote that day on whether to recommend its use for children 5 to 11. If the committee votes in favor, CDC Director Rochelle Walensky will next need to sign off on the recommendation. That would likely happen quickly, and after that, vaccinations can begin. If all goes smoothly, vaccinations in young children could start as soon as Wednesday, November 3.
According to survey data on COVID-19 vaccination released Thursday by the Kaiser Family Foundation, only about 27 percent of parents are planning to vaccinate their 5–11-year-old children right away. An additional 33 percent of parents said they would “wait and see.” A full 30 percent responded that they would “definitely not” vaccinate their children, and 5 percent said they would only immunize their children if they were required to do so. The survey found that a top concern among hesitant parents is the vaccine’s safety.
The FDA seemed to acknowledge those widespread concerns in their announcement of the authorization Friday afternoon. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, tried to reassure parents of the vaccine’s safety and the rigorous review that the agency undertook before issuing the authorization.
“We are confident in the safety, effectiveness, and manufacturing data behind this authorization,” Marks said in a statement. “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.”
